Phase 2
N=124
Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Bronchopulmonary Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT00955487 ↗Enrolled (actual)
124
Serious AEs
55.7%
Results posted
May 2017
Primary outcome: Primary: Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality — 1; 2; 24; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Inhaled Nitric Oxide (iNO) (Drug); Nitrogen (placebo) (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality |
1; 2; 24; 25; 25; 26 | — |
| PRIMARY Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight |
0; 2; 1; 0; 0; 0 | — |
| SECONDARY Severity of Bronchopulmonary Dysplasia (BPD) |
35; 37; 2; 9; 20; 12 | — |
| SECONDARY Need for Mechanical Ventilation |
13; 15; 46; 50 | — |
| SECONDARY Total Ventilation Days |
9.7; 8.4 | — |
| SECONDARY Necrotizing Enterocolitis (NEC) |
5; 10 | — |
| SECONDARY Symptomatic PDA Requiring Medical Treatment |
1; 2 | — |
| SECONDARY Symptomatic PDA Requiring Surgical Ligation |
3; 8 | — |
| SECONDARY Threshold Retinopathy of Prematurity (ROP) |
3; 4 | — |
| SECONDARY Severe Intracranial Hemorrhage |
2; 4 | — |
| SECONDARY Sepsis |
13; 14 | — |
Summary
Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns. The condition involves abnormal development of lung tissue and is characterized by inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce the incidence of BPD and another commonly associated condition called pulmonary hypertension, which is high blood pressure in the vessels carrying blood to the lungs.. This study will determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary hypertension, and death in premature newborns.
Eligibility Criteria
Inclusion Criteria
- Birth weight of 500-1250 grams and gestational age of less than 34 weeks
- Age at enrollment is less than 72 hours
- Supplemental oxygen or 21% requirement by nasal cannula or NCPAP only
Exclusion Criteria
- Presence of structural heart disease (other than patent ductus arteriosus, atrial septal defect less than 1 cm, or muscular ventricular septal defect less than 2 mm)
- Presence of lethal congenital anomaly
- Participating in another concurrent experimental study
- Requires mechanical ventilation in the first 72 hours of life (patients are not excluded if they are intubated briefly but they must be extubated at the time of consent and study entry prior to 72 hours of life)
Data sourced from ClinicalTrials.gov (NCT00955487). 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.