Trial Outcomes & Findings for Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants (NCT NCT00931632)
NCT ID: NCT00931632
Last Updated: 2017-12-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
451 participants
Primary outcome timeframe
Baseline, 36 weeks PMA
Results posted on
2017-12-04
Participant Flow
Participant milestones
| Measure |
Inhaled Nitric Oxide
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Overall Study
STARTED
|
229
|
222
|
|
Overall Study
COMPLETED
|
208
|
204
|
|
Overall Study
NOT COMPLETED
|
21
|
18
|
Reasons for withdrawal
| Measure |
Inhaled Nitric Oxide
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Adverse Event
|
19
|
15
|
Baseline Characteristics
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
Baseline characteristics by cohort
| Measure |
Inhaled Nitric Oxide
n=229 Participants
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=222 Participants
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
Total
n=451 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
229 participants
n=5 Participants
|
222 participants
n=7 Participants
|
451 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
120 participants
n=5 Participants
|
85 participants
n=7 Participants
|
205 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
55 participants
n=5 Participants
|
62 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
40 participants
n=5 Participants
|
48 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
209 participants
n=5 Participants
|
203 participants
n=7 Participants
|
412 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 36 weeks PMAPopulation: Subjects with missing primary outcome or who crossed over to open-label iNO during the blinded treatment period were considered as failures
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=229 Participants
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=222 Participants
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Survival Without BPD at 36 Weeks
Alive without BPD at 36 weeks GA
|
80 participants
|
70 participants
|
|
Survival Without BPD at 36 Weeks
Death or had BPD at 36 weeks GA
|
149 participants
|
152 participants
|
SECONDARY outcome
Timeframe: Through hospital discharge, an average of 105 days for placebo and 108 days for INOAirway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=229 Participants
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=220 Participants
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Days of Airway Pressure Support - Intent-to-treat Population
|
53.7 Days
Standard Deviation 42.16
|
55.3 Days
Standard Deviation 40.45
|
SECONDARY outcome
Timeframe: Through hospital discharge, an average of 105 days for placebo and 108 days for INOPopulation: Number of subjects within the Intent-to-treat population with available data
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=201 Participants
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=203 Participants
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Length of Birth Hospitalization
|
108.3 Days
Standard Deviation 54.03
|
105.0 Days
Standard Deviation 36.69
|
SECONDARY outcome
Timeframe: Through hospital discharge, an average of 105 days for placebo and 108 days for INOPopulation: Intent-to-treat population
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=229 Participants
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=222 Participants
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia
Yes
|
95 Participants
|
91 Participants
|
|
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia
No
|
134 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: Through hospital discharge, an average of 105 days for placebo and 108 days for INOPopulation: Intent-to-treat population
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=229 Participants
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=222 Participants
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason
|
154 Participants
|
145 Participants
|
SECONDARY outcome
Timeframe: Through hospital discharge, an average of 105 days for placebo and 108 days for INOPopulation: Intent-to-treat population
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=229 Participants
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=222 Participants
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Systemic Use of Postnatal Corticosteroids for Any Medical Reason
|
144 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: Through hospital discharge, an average of 105 days for placebo and 108 days for INOPopulation: Number of subjects within the Intent-to-treat population with available data
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=207 Participants
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=212 Participants
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Number of Days of Oxygen Use
|
91.0 Days
Standard Deviation 59.26
|
88.0 Days
Standard Deviation 40.91
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Number of subjects within the Intent-to-treat population with available data
Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=207 Participants
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=211 Participants
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Severity of Bronchopulmonary Dysplasia
0 = None
|
1 Participants
|
2 Participants
|
|
Severity of Bronchopulmonary Dysplasia
1 = Mild
|
80 Participants
|
72 Participants
|
|
Severity of Bronchopulmonary Dysplasia
2 = Moderate
|
83 Participants
|
82 Participants
|
|
Severity of Bronchopulmonary Dysplasia
3 = Severe
|
43 Participants
|
55 Participants
|
Adverse Events
Inhaled Nitric Oxide
Serious events: 105 serious events
Other events: 169 other events
Deaths: 12 deaths
Placebo
Serious events: 100 serious events
Other events: 143 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Inhaled Nitric Oxide
n=229 participants at risk
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=220 participants at risk
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
14.8%
34/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
15.5%
34/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
4.8%
11/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
6.8%
15/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Sepsis
|
10.9%
25/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
12.3%
27/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Blood and lymphatic system disorders
Anemia neonatal
|
1.7%
4/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
2.7%
6/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.87%
2/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
1.8%
4/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Blood and lymphatic system disorders
Hemolytic anemia
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Cardiac disorders
Bradycardia
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Cardiac disorders
Pneumopericardium
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Cardiac disorders
Ventricular fibrillation
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Congenital, familial and genetic disorders
Persistent fetal circulation
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.91%
2/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Congenital, familial and genetic disorders
Adrenogenital syndrome
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Congenital, familial and genetic disorders
Hereditary spherocytosis
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Gastrointestinal disorders
Intestinal perforation
|
3.5%
8/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
1.8%
4/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Gastrointestinal disorders
Abdominal distension
|
0.87%
2/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Gastrointestinal disorders
Esophageal perforation
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Staphylococcal sepsis
|
3.1%
7/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
1.8%
4/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Group B streptococcus neonatal sepsis
|
1.3%
3/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Pneumonia
|
1.3%
3/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
3.2%
7/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Septic shock
|
1.3%
3/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Fungal sepsis
|
0.87%
2/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Pneumonia bacterial
|
0.87%
2/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.91%
2/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Urinary tract infection
|
0.87%
2/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.91%
2/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Bacterial sepsis
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.91%
2/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Beta hemolytic streptococcal infection
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Enterococcal sepsis
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Lung infection pseudomonal
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.91%
2/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Staphylococcal bacteremia
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Staphylococcal infection
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.91%
2/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Lung abscess
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Meningitis candida
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Tracheitis
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Investigations
Bacterial test positive
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Investigations
CST culture positive
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Investigations
Candida test positive
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
1.4%
3/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Nervous system disorders
Hydrocephalus
|
1.3%
3/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.91%
2/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Nervous system disorders
Intraventricular hemorrhage neonatal
|
1.3%
3/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
1.4%
3/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Nervous system disorders
Encephalomalacia
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Nervous system disorders
Hemorrhage intracranial
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Nervous system disorders
Periventricular leukomalacia
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Renal and urinary disorders
Renal failure
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Renal and urinary disorders
Renal failure acute
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.91%
2/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
4/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
2.3%
5/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoeic attack
|
0.87%
2/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
1.4%
3/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Surgical and medical procedures
Thoracotomy
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Vascular disorders
Hypotension
|
3.1%
7/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.91%
2/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Vascular disorders
Aortic thrombosis
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Vascular disorders
Arterial spasm
|
0.44%
1/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.00%
0/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Vascular disorders
Thrombosis
|
0.00%
0/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
0.45%
1/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
Other adverse events
| Measure |
Inhaled Nitric Oxide
n=229 participants at risk
Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
|
Placebo
n=220 participants at risk
Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
28.8%
66/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
22.7%
50/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
12.7%
29/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
13.2%
29/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.7%
13/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
3.6%
8/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
|
4.4%
10/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
5.5%
12/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
12.7%
29/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
9.5%
21/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
5.2%
12/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
5.5%
12/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.4%
10/229 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
5.0%
11/220 • Through treatment completion, up to 24 days
During treatment of 24 day course
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site shall use Confidential Information solely for the purposes of preforming its obligations under the Clinical Study Agreement and shall not, without Sponsor's prior written consent, publish, disseminate or otherwise disclose to any third party (including any of its affiliates) any Confidential Information. These obligations shall survive and continue for ten years after the termination or expiration of the Agreement or such longer period as required by Applicable Law.
- Publication restrictions are in place
Restriction type: OTHER