Phase 3
N=451
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
Bronchopulmonary Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT00931632 ↗Enrolled (actual)
451
Serious AEs
45.7%
Results posted
Aug 2015
Primary outcome: Primary: Survival Without BPD at 36 Weeks — 80; 70; 149; 152 participants — p=0.427
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Inhaled Nitric Oxide (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Mallinckrodt
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Without BPD at 36 Weeks |
80; 70; 149; 152 | 0.427 |
| SECONDARY Days of Airway Pressure Support - Intent-to-treat Population |
53.7; 55.3 | — |
| SECONDARY Length of Birth Hospitalization |
108.3; 105.0 | — |
| SECONDARY Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia |
95; 91; 134; 131 | — |
| SECONDARY Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason |
154; 145 | — |
| SECONDARY Systemic Use of Postnatal Corticosteroids for Any Medical Reason |
144; 131 | — |
| SECONDARY Number of Days of Oxygen Use |
91.0; 88.0 | — |
| SECONDARY Severity of Bronchopulmonary Dysplasia |
1; 2; 80; 72; 83; 82 | — |
Summary
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.
Eligibility Criteria
Inclusion Criteria
- Preterm infants who are:
- 500 to 1250 grams at birth
- < 30 weeks gestational age
- 5 to 14 days of age (inclusive) at the time of entry
- Requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)
Exclusion Criteria
- Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care
- Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
- Subjects who are dependent on right to left shunting to maintain the systemic circulation
- Preterm infants who received prior iNO therapy
- Use of another investigational agent
Data sourced from ClinicalTrials.gov (NCT00931632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.