Trial Outcomes & Findings for A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact (NCT NCT03969992)

NCT ID: NCT03969992

Last Updated: 2025-08-07

Results Overview

Number of patients who require intubation/cannulation with bolus surfactant instillation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 261 participants
• Primary outcome timeframe: First 7 days of life
• Results posted on: 2025-08-07

Participant Flow

Participant milestones

Measure	Control: nCPAP Alone nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact AeroFact 108 mg/kg/dose	Drug: High Dose AeroFact AeroFact 216 mg/kg/dose
Part 1: Birth to Discharge/40 Weeks PMA STARTED	92	83	86
Part 1: Birth to Discharge/40 Weeks PMA COMPLETED	89	80	81
Part 1: Birth to Discharge/40 Weeks PMA NOT COMPLETED	3	3	5
Part 2: Discharge/40 Wks PMA to 12 Mos STARTED	89	80	81
Part 2: Discharge/40 Wks PMA to 12 Mos COMPLETED	74	71	71
Part 2: Discharge/40 Wks PMA to 12 Mos NOT COMPLETED	15	9	10

Reasons for withdrawal

Measure	Control: nCPAP Alone nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact AeroFact 108 mg/kg/dose	Drug: High Dose AeroFact AeroFact 216 mg/kg/dose
Part 1: Birth to Discharge/40 Weeks PMA Withdrawal by Subject	1	0	3
Part 1: Birth to Discharge/40 Weeks PMA Death	2	3	2
Part 2: Discharge/40 Wks PMA to 12 Mos Lost to Follow-up	12	8	9
Part 2: Discharge/40 Wks PMA to 12 Mos Physician Decision	0	0	1
Part 2: Discharge/40 Wks PMA to 12 Mos Withdrawal by Subject	3	1	0

Baseline Characteristics

A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact

Baseline characteristics by cohort

Measure	Control: nCPAP Alone n=92 Participants nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact n=83 Participants AeroFact-low dose SF-RI 1	Drug: High Dose AeroFact n=86 Participants AeroFact-high dose SF-RI 1	Total n=261 Participants Total of all reporting groups
Age, Continuous	29.2 weeks gestational age STANDARD_DEVIATION 1.3 • n=5 Participants	29.1 weeks gestational age STANDARD_DEVIATION 1.4 • n=7 Participants	29.1 weeks gestational age STANDARD_DEVIATION 1.5 • n=5 Participants	29.2 weeks gestational age STANDARD_DEVIATION 1.4 • n=4 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	38 Participants n=7 Participants	37 Participants n=5 Participants	122 Participants n=4 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	45 Participants n=7 Participants	49 Participants n=5 Participants	139 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	22 Participants n=7 Participants	12 Participants n=5 Participants	47 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants	58 Participants n=7 Participants	72 Participants n=5 Participants	207 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 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=4 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	43 Participants n=4 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	50 Participants n=7 Participants	48 Participants n=5 Participants	155 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	20 Participants n=7 Participants	14 Participants n=5 Participants	50 Participants n=4 Participants
Birth weight	1195.1 grams STANDARD_DEVIATION 297.9 • n=5 Participants	1245.1 grams STANDARD_DEVIATION 301.5 • n=7 Participants	1248.7 grams STANDARD_DEVIATION 303.9 • n=5 Participants	1228.7 grams STANDARD_DEVIATION 300.9 • n=4 Participants
Vaginal delivery	14 Participants n=5 Participants	25 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Multiple gestation	30 Participants n=5 Participants	29 Participants n=7 Participants	26 Participants n=5 Participants	85 Participants n=4 Participants
Age at Randomization	10.0 hours STANDARD_DEVIATION 7.2 • n=5 Participants	8.2 hours STANDARD_DEVIATION 6.5 • n=7 Participants	8.9 hours STANDARD_DEVIATION 6.9 • n=5 Participants	9.1 hours STANDARD_DEVIATION 6.9 • n=4 Participants
FiO2 at Randomization	0.27 Percentage of inspired oxygen STANDARD_DEVIATION 0.05 • n=5 Participants	0.27 Percentage of inspired oxygen STANDARD_DEVIATION 0.04 • n=7 Participants	0.27 Percentage of inspired oxygen STANDARD_DEVIATION 0.05 • n=5 Participants	0.27 Percentage of inspired oxygen STANDARD_DEVIATION 0.05 • n=4 Participants
Respiratory Severity Score at Randomization	1.7 units on a scale STANDARD_DEVIATION 0.2 • n=5 Participants	1.7 units on a scale STANDARD_DEVIATION 0.2 • n=7 Participants	1.7 units on a scale STANDARD_DEVIATION 0.3 • n=5 Participants	1.7 units on a scale STANDARD_DEVIATION 0.2 • n=4 Participants

PRIMARY outcome

Timeframe: First 7 days of life

Population: Per Protocol population

Number of patients who require intubation/cannulation with bolus surfactant instillation

Outcome measures

Measure	Control: nCPAP Alone n=89 Participants nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact n=68 Participants AeroFact-low dose SF-RI 1	Drug: High Dose AeroFact n=70 Participants AeroFact-high dose SF-RI 1
Intubation/Cannulation and Instilled Surfactant	45 Participants	21 Participants	26 Participants

SECONDARY outcome

Timeframe: First 7 days of life

Population: Per protocol population

Time from randomization to intubation/cannulation and bolus surfactant instillation in the first 7 days of life

Outcome measures

Measure	Control: nCPAP Alone n=45 Participants nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact n=21 Participants AeroFact-low dose SF-RI 1	Drug: High Dose AeroFact n=26 Participants AeroFact-high dose SF-RI 1
Time to First Intubation/Cannulation and Bolus Surfactant Instillation	17.5 hours Interval 2.0 to 53.9	13.6 hours Interval 3.2 to 43.4	22.4 hours Interval 1.8 to 53.7

SECONDARY outcome

Timeframe: First 7 days of life

Population: Per protocol population

Outcome measures

Measure	Control: nCPAP Alone n=89 Participants nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact n=68 Participants AeroFact-low dose SF-RI 1	Drug: High Dose AeroFact n=70 Participants AeroFact-high dose SF-RI 1
Proportion of Infants Who Received Multiple Doses of Bolus Surfactant	7 Participants	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Assessed daily from birth to 40 weeks post-menstrual age or discharge

Population: Per protocol population

Total number of days each participant required support with invasive mechanical ventilation

Outcome measures

Measure	Control: nCPAP Alone n=44 Participants nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact n=28 Participants AeroFact-low dose SF-RI 1	Drug: High Dose AeroFact n=28 Participants AeroFact-high dose SF-RI 1
Number of Days on Invasive Mechanical Ventilation	4.8 Days Standard Deviation 7.1	6.0 Days Standard Deviation 16.7	4.0 Days Standard Deviation 4.7

SECONDARY outcome

Timeframe: Birth to 36 weeks post-menstrual age

Population: Per protocol population

Total number of patients per treatment group who were alive and did not experience BPD at 36 weeks PMA

Outcome measures

Measure	Control: nCPAP Alone n=89 Participants nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact n=68 Participants AeroFact-low dose SF-RI 1	Drug: High Dose AeroFact n=70 Participants AeroFact-high dose SF-RI 1
Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post-menstrual Age (PMA)	69 Participants	55 Participants	53 Participants

SECONDARY outcome

Timeframe: Birth to 40 weeks post-menstrual age

Population: Per protocol population

Total number of patients per treatment group who were alive and did not experience BPD at 40 weeks PMA

Outcome measures

Measure	Control: nCPAP Alone n=89 Participants nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact n=68 Participants AeroFact-low dose SF-RI 1	Drug: High Dose AeroFact n=70 Participants AeroFact-high dose SF-RI 1
Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA)	74 Participants	58 Participants	56 Participants

Adverse Events

Control: nCPAP Alone

Serious events: 7 serious events

Other events: 43 other events

Deaths: 2 deaths

Drug: Low Dose AeroFact

Serious events: 9 serious events

Other events: 45 other events

Deaths: 3 deaths

Drug: High Dose AeroFact

Serious events: 5 serious events

Other events: 42 other events

Deaths: 2 deaths

Serious adverse events

Measure	Control: nCPAP Alone n=92 participants at risk nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact n=83 participants at risk AeroFact-low dose SF-RI 1	Drug: High Dose AeroFact n=86 participants at risk AeroFact-high dose SF-RI 1
Gastrointestinal disorders Necrotizing enterocolitis neonatal	2.2% 2/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	2.4% 2/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	2.3% 2/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Gastrointestinal disorders Gastrointestinal perforation	1.1% 1/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	2.4% 2/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Gastrointestinal disorders Meconium ileus	1.1% 1/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.1% 1/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	2.4% 2/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	2.3% 2/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage neonatal	0.00% 0/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	2.4% 2/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Cardiac disorders Cardiac dysfunction	0.00% 0/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	1.2% 1/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Cardiac disorders Cardiac tamponade	1.1% 1/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Infections and infestations Sepsis	1.1% 1/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	1.2% 1/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Nervous system disorders Intraventricular hemorrhage neonatal	0.00% 0/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	2.4% 2/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Renal and urinary disorders Acute kidney injury	0.00% 0/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	1.2% 1/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.

Other adverse events

Measure	Control: nCPAP Alone n=92 participants at risk nCPAP (nasal continuous positive airway pressure) alone	Drug: Low Dose AeroFact n=83 participants at risk AeroFact-low dose SF-RI 1	Drug: High Dose AeroFact n=86 participants at risk AeroFact-high dose SF-RI 1
Nervous system disorders Intraventricular hemorrhage neonatal	6.5% 6/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	18.1% 15/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	20.9% 18/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Eye disorders Retinopathy or prematurity	15.2% 14/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	15.7% 13/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	15.1% 13/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.3% 3/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	6.0% 5/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	4.7% 4/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Respiratory, thoracic and mediastinal disorders Infantile apnea	3.3% 3/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	1.2% 1/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	1.2% 1/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory failure	0.00% 0/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	1.2% 1/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	2.3% 2/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage neonatal	0.00% 0/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	2.4% 2/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Congenital, familial and genetic disorders Patent ductus arteriosus	12.0% 11/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	6.0% 5/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	4.7% 4/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Gastrointestinal disorders Necrotizing enterocolitis neonatal	5.4% 5/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	6.0% 5/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	5.8% 5/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Gastrointestinal disorders Gastrointestinal perforation	1.1% 1/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	3.6% 3/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Gastrointestinal disorders Inguinal hernia	2.2% 2/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	1.2% 1/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	1.2% 1/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Infections and infestations Sepsis	4.3% 4/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	6.0% 5/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	3.5% 3/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Cardiac disorders Bradycardia neonatal	2.2% 2/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	7.2% 6/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	1.2% 1/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Surgical and medical procedures Patent ductus arteriosus repair	4.3% 4/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	1.2% 1/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.
Vascular disorders Hypotension	0.00% 0/92 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	2.4% 2/83 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.	0.00% 0/86 • AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.

Additional Information

David Durand, MD

Aerogen Pharma

Phone: 510-928-2111

Email: ddurand@aerogenpharma.com

Results disclosure agreements

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