Trial Outcomes & Findings for Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns (NCT NCT00955487)
NCT ID: NCT00955487
Last Updated: 2017-06-15
Results Overview
Number of participants that developed bronchopulmonary dysplasia and/or that died
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Week 36 or earlier, if participants are discharged from the hospital
Results posted on
2017-06-15
Participant Flow
Participant milestones
| Measure |
500-749g Inhaled Nitric Oxide (iNO)
Participants weighing between 500 and 749 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
500-749g Placebo (Nitrogen)
Participants weighing between 500 and 749 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
17
|
21
|
32
|
35
|
|
Overall Study
COMPLETED
|
10
|
9
|
17
|
21
|
32
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Baseline characteristics by cohort
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Gestational Age at Baseline
|
27.5 Weeks
STANDARD_DEVIATION 1.6 • n=93 Participants
|
27.3 Weeks
STANDARD_DEVIATION 1.8 • n=4 Participants
|
27.4 Weeks
STANDARD_DEVIATION 1.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
48 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
96 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
59 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
124 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 36 or earlier, if participants are discharged from the hospitalNumber of participants that developed bronchopulmonary dysplasia and/or that died
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality
Death
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality
Bronchopulmonary Dysplasia (BPD)
|
24 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
|
Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality
Death/BPD
|
25 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
|
Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality
No Death or BPD
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Randomization to dischargeNumber of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams)
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=10 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=9 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
n=17 Participants
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
n=21 Participants
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
n=32 Participants
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
n=35 Participants
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight
Death
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight
BPD
|
3 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
13 Participants
|
15 Participants
|
|
Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight
Death/BPD
|
3 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
13 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 36 weeks corrected gestational ageAssessment of the severity of BPD as defined by the oxygen reduction test
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=62 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Severity of Bronchopulmonary Dysplasia (BPD)
None
|
35 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Severity of Bronchopulmonary Dysplasia (BPD)
Mild
|
2 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Severity of Bronchopulmonary Dysplasia (BPD)
Moderate
|
20 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Severity of Bronchopulmonary Dysplasia (BPD)
Severe
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Anytime after randomization up to 36 weeks corrected gestational ageNumber of participants who required endotracheal intubation and mechanical ventilation
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Need for Mechanical Ventilation
Required Mechanical Ventilation
|
13 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Need for Mechanical Ventilation
Did not require mechanical ventilation
|
46 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After randomization up until hospital dischargeOf those participants who required mechanical ventilation, the total number of days receiving ventilation
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Total Ventilation Days
|
9.7 Days
Standard Deviation 29
|
8.4 Days
Standard Deviation 12
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After randomization through hospital dischargeNumber of participants diagnosed with necrotizing enterocolitis
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Necrotizing Enterocolitis (NEC)
|
5 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until dischargeNumber of participants with a symptomatic PDA that required medical treatment
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Symptomatic PDA Requiring Medical Treatment
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomization through dischargeNumber of participants with symptomatic PDA that required surgical ligation
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Symptomatic PDA Requiring Surgical Ligation
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomization to dischargeThreshold ROP defined as requiring interventional therapy
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Threshold Retinopathy of Prematurity (ROP)
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomization to dischargeNumber of participants that developed severe intracranial hemorrhage (grade 3-4)
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Severe Intracranial Hemorrhage
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomization to dischargeNumber of participants that developed sepsis
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Sepsis
|
13 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From birth to hospital dischargeLength of stay of participants
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 Participants
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 Participants
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
750-999g Inhaled Nitric Oxide (iNO)
Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
750-999g Placebo (Nitrogen)
Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Inhaled Nitric Oxide (iNO)
Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
1000-1250g Placebo (Nitrogen)
Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx.
|
|---|---|---|---|---|---|---|
|
Days in Hospital
|
75 Days
Standard Deviation 32
|
75 Days
Standard Deviation 29
|
—
|
—
|
—
|
—
|
Adverse Events
Inhaled Nitric Oxide (iNO)
Serious events: 27 serious events
Other events: 0 other events
Deaths: 2 deaths
Placebo (Nitrogen)
Serious events: 42 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Inhaled Nitric Oxide (iNO)
n=59 participants at risk
Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
Placebo (Nitrogen)
n=65 participants at risk
Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
|
|---|---|---|
|
Gastrointestinal disorders
Necrotizing enterocolitis
|
8.5%
5/59 • Number of events 5
|
15.4%
10/65 • Number of events 10
|
|
Cardiac disorders
Symptomatic PDA
|
5.1%
3/59 • Number of events 3
|
12.3%
8/65 • Number of events 8
|
|
Eye disorders
Threshold ROP
|
5.1%
3/59 • Number of events 3
|
6.2%
4/65 • Number of events 4
|
|
Nervous system disorders
Severe ICH
|
3.4%
2/59 • Number of events 2
|
6.2%
4/65 • Number of events 4
|
|
Infections and infestations
Sepsis
|
22.0%
13/59 • Number of events 13
|
21.5%
14/65 • Number of events 14
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. John Kinsella
University of Colorado School of Medicine/Children's Hospital Colorado
Phone: (303) 724-2853
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place