Trial Outcomes & Findings for Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial (NCT NCT02907593)

NCT ID: NCT02907593

Last Updated: 2025-04-04

Results Overview

Dose escalation will be defined as effective at the dose level in which 5 of 8 infants achieve the following: 1. Extubation within 72 hours of first dose or after \< 3 doses-without re-intubation before 28 days of age 2. RSS on nasal continuous positive airway pressure (NCPAP) \< 1.5 or on nasal cannula Fi02 \<25% at \< 2L/min at 28 days of age, persisting for at least 72 hours. 3. Cumulative supplemental oxygen \< 4.2 from time of enrollment to 28 days of age 4 4. No respiratory support at 28 days, including no supplemental oxygen by nasal cannula AND a \> 50% suppression of the tracheal aspirate interleukin-8 (IL-8) or CCL2 (chemokine ligand 2) at 24-72 hours (or prior to extubation if occurs at \<24 hours after dosing) after the initial dose in 5 of 8 of the infants (this may be a different combination of 5 patients than those who met the above criteria).

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: 28 days of life for each dosing group
• Results posted on: 2025-04-04

Participant Flow

Participant milestones

Measure	0.025 mg/kg Budesonide 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
Overall Study STARTED	8	8	9	0
Overall Study COMPLETED	8	8	8	0
Overall Study NOT COMPLETED	0	0	1	0

Reasons for withdrawal

Measure	0.025 mg/kg Budesonide 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
Overall Study Withdrawal by Subject	0	0	1	0

Baseline Characteristics

Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial

Baseline characteristics by cohort

Measure	0.025 mg/kg Budesonide n=8 Participants 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide n=8 Participants 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide n=9 Participants 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	0 Participants n=4 Participants	25 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	25.3 gestational age in weeks STANDARD_DEVIATION 1.64 • n=5 Participants	25.3 gestational age in weeks STANDARD_DEVIATION 1.25 • n=7 Participants	24.4 gestational age in weeks STANDARD_DEVIATION 0.89 • n=5 Participants	—	25.0 gestational age in weeks STANDARD_DEVIATION 1.31 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	—	12 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	—	13 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	—	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	—	18 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	—	2 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	—	21 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	—	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	1 Participants n=21 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	9 participants n=5 Participants	—	25 participants n=21 Participants
Number of participants that completed study	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	0 Participants n=4 Participants	24 Participants n=21 Participants

PRIMARY outcome

Timeframe: 28 days of life for each dosing group

Population: Extremely low gestational age infants (ELGANs), born before 28 weeks gestation.

Dose escalation will be defined as effective at the dose level in which 5 of 8 infants achieve the following:

1. Extubation within 72 hours of first dose or after < 3 doses-without re-intubation before 28 days of age

2. RSS on nasal continuous positive airway pressure (NCPAP) < 1.5 or on nasal cannula Fi02 <25% at < 2L/min at 28 days of age, persisting for at least 72 hours.

3. Cumulative supplemental oxygen < 4.2 from time of enrollment to 28 days of age 4

4. No respiratory support at 28 days, including no supplemental oxygen by nasal cannula

AND a > 50% suppression of the tracheal aspirate interleukin-8 (IL-8) or CCL2 (chemokine ligand 2) at 24-72 hours (or prior to extubation if occurs at <24 hours after dosing) after the initial dose in 5 of 8 of the infants (this may be a different combination of 5 patients than those who met the above criteria).

Outcome measures

Measure	0.025 mg/kg Budesonide n=8 Participants 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide n=8 Participants 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide n=8 Participants 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
Number of ELGANs With Clinical and Anti-inflammatory Efficacy of Escalating Doses of Budesonide Determined by Monitoring Respiratory Severity Score (RSS)	1 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 28 days of life for each dosing group

Population: No patient at the 0.025 mg/kg or at the 0.05 mg/kg or at the 0.10 mg/kg dosing level met the criteria for the primary outcome of a clinical and cytokine response. Due to this lack of response, we were approved by the Thrasher Foundation to not perform the dosing at the 0.15 mg/kg dosing level.

Number of ELGANS with a clinical AND Cytokine response: a > 50% suppression of the tracheal aspirate interleukin-8 or chemokine ligand 2 at 24-72 hours (or prior to extubation if occurs at <24 hours after dosing) after the initial dose in 5 of 8 of the infants

Outcome measures

Measure	0.025 mg/kg Budesonide n=8 Participants 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide n=8 Participants 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide n=8 Participants 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
The Clinical and Anti-inflammatory Efficacy of Escalating Doses of Budesonide Suspended in Calfactant and Given Into the Lungs of ELGANs by Monitoring Tracheal Aspirate Cytokine Levels.	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through 28 days of life

Population: No SAEs were considered to be treatment related.

Safety assessments will include the subject's vital signs, clinical laboratory testing, morbidities associated with prematurity, morbidities associated with administration of budesonide in calfactant, and Adverse Events (AE)s. Clinical parameters/ AEs of interest are those potentially consistent with elevated glucocorticoid levels and will be specifically evaluated. A Data and Safety Monitoring Board (DSMB) will be established to review safety data. All of the data will be reviewed to monitor subject safety.

Outcome measures

Measure	0.025 mg/kg Budesonide n=8 Participants 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide n=8 Participants 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide n=8 Participants 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
Adverse Events/Subject Safety	8 Participants	8 Participants	8 Participants	—

SECONDARY outcome

Timeframe: At 15 minutes, 1 and 4 hours after first dose and prior to each additional dose

The research team will obtain dried blood spot samples at 15 minutes, and 1 and 4 hours after the first dose of budesonide in calfactant for budesonide levels. Trough concentrations (Cmin) will be drawn before potential subsequent daily doses.

Outcome measures

Measure	0.025 mg/kg Budesonide n=8 Participants 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide n=8 Participants 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide n=9 Participants 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
Serial Budesonide Levels, Peak	7.70 ng/mL Interval 7.7 to 18.7	8.60 ng/mL Interval 7.7 to 18.7	18.7 ng/mL Interval 7.7 to 18.7	—

SECONDARY outcome

Timeframe: At 15 minutes, 1 and 4 hours after first dose and prior to each additional dose

The research team will obtain dried blood spot samples at 15 minutes, and 1 and 4 hours after the first dose of budesonide in calfactant for budesonide levels. Trough concentrations (Cmin) will be drawn before potential subsequent daily doses.

Outcome measures

Measure	0.025 mg/kg Budesonide n=8 Participants 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide n=8 Participants 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide n=9 Participants 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
Serial Budesonide Levels, T 1/2	3.78 h Interval 3.2 to 3.78	3.20 h Interval 3.2 to 3.78	3.20 h Interval 3.2 to 3.78	—

SECONDARY outcome

Timeframe: At 15 minutes, 1 and 4 hours after first dose and prior to each additional dose

The research team will obtain dried blood spot samples at 15 minutes, and 1 and 4 hours after the first dose of budesonide in calfactant for budesonide levels. Trough concentrations (Cmin) will be drawn before potential subsequent daily doses.

Outcome measures

Measure	0.025 mg/kg Budesonide n=8 Participants 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide n=8 Participants 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide n=9 Participants 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
Serial Budesonide Levels, AUC	39.4 ng*h/mL Interval 37.2 to 73.5	37.2 ng*h/mL Interval 37.2 to 73.5	73.5 ng*h/mL Interval 37.2 to 73.5	—

SECONDARY outcome

Timeframe: 28 days of life for each dosing group

Clinical respiratory status (RSS and oxygen requirement) around dosing and at 28 days of age will be compared between dosing groups and also compared to the matched historical control patients from the "Trial of Late Surfactant:(TOLSURF) study.

The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2). This score ranges from 0 to 12, with a higher score indicating more severe disease.

Outcome measures

Measure	0.025 mg/kg Budesonide n=8 Participants 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide n=8 Participants 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide n=5 Participants 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
Respiratory Severity Score: Mean Airway Pressure and Oxygen Requirement at 28 Days of Age	4.59 Respiratory Severity Score Standard Deviation 3.74	4.94 Respiratory Severity Score Standard Deviation 2.93	3.74 Respiratory Severity Score Standard Deviation 2.97	—

Adverse Events

0.025 mg/kg Budesonide

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

0.050 mg/kg Budesonide

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

0.10 mg/kg Budesonide

Serious events: 4 serious events

Other events: 8 other events

Deaths: 3 deaths

0.15 mg/kg Budesonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	0.025 mg/kg Budesonide n=8 participants at risk 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide n=8 participants at risk 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide n=9 participants at risk 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
Respiratory, thoracic and mediastinal disorders Severe Respiratory Decompensation	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Infections and infestations Sepsis	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	22.2% 2/9 • Number of events 2 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Gastrointestinal disorders Necrotizing Enterocolitis	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.

Other adverse events

Measure	0.025 mg/kg Budesonide n=8 participants at risk 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.050 mg/kg Budesonide n=8 participants at risk 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.10 mg/kg Budesonide n=9 participants at risk 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant	0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant
Respiratory, thoracic and mediastinal disorders Apnea	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Blood and lymphatic system disorders Anemia	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	22.2% 2/9 • Number of events 2 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Respiratory, thoracic and mediastinal disorders Bradycardia	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	25.0% 2/8 • Number of events 2 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/9 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Cardiac disorders Cardiopulmonary arrest	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Metabolism and nutrition disorders Elevated blood gas	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/9 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Renal and urinary disorders Increased urine output	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/9 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Nervous system disorders Intraventricular hemorrhage	25.0% 2/8 • Number of events 2 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/9 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	33.3% 3/9 • Number of events 3 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
General disorders Presumed formula aspiratiom	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/9 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Injury, poisoning and procedural complications Reflux into ETT during dosing	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/9 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Cardiac disorders PDA requiring treatment	75.0% 6/8 • Number of events 6 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	62.5% 5/8 • Number of events 5 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	33.3% 3/9 • Number of events 3 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Respiratory, thoracic and mediastinal disorders Pulmonary decompensation	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	22.2% 2/9 • Number of events 2 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
General disorders Re-intubation during study	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Renal and urinary disorders Renal insufficiency	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/9 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Infections and infestations Sepsis	25.0% 2/8 • Number of events 2 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	25.0% 2/8 • Number of events 3 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Blood and lymphatic system disorders Severe hypotension	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	25.0% 2/8 • Number of events 2 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Respiratory, thoracic and mediastinal disorders Severe respiratory decompensation	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Respiratory, thoracic and mediastinal disorders Severe pulmonary hemorrhage	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Cardiac disorders Supraventricular tachycardia	12.5% 1/8 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/9 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Metabolism and nutrition disorders Uncontrolled hyperglycemia	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	0.00% 0/8 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	11.1% 1/9 • Number of events 1 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.	— 0/0 • Adverse event data was collected through 28 days of life. Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.

Additional Information

Dr. Cindy McEvoy

Oregon Health & Science University

Phone: 5034945598

Email: mcevoyc@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place