Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Completed · Phase 2 · Has a placebo group
Conditions studied: Bronchopulmonary Dysplasia
In brief
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.
Key facts
- Study ID
- NCT00955487
- Run by
- University of Colorado, Denver
- People needed
- 124
- Starts
- 2007-01-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-06-15
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- University of California San Diego — San Diego, California, United States
- Children's Hospital and University Colorado Hospital — Aurora, Colorado, United States
- Anne and Robert H. Lurie Children's Hospital of Chicago and Northwestern Memorial Hospital — Chicago, Illinois, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Vanderbilt Children's Hospital — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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