Status:
COMPLETED
Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
Up to 72 years
Phase:
PHASE2
Brief 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 scarri...
Detailed Description
BPD is a serious lung condition that primarily affects premature newborns and newborns with low birth weights. iNO has been proven to be a safe and effective treatment for pulmonary hypertension and h...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00955487
Start Date
January 1 2007
End Date
December 1 2014
Last Update
June 15 2017
Active Locations (6)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35242
2
University of California San Diego
San Diego, California, United States, 92123
3
Children's Hospital and University Colorado Hospital
Aurora, Colorado, United States, 80045
4
Anne and Robert H. Lurie Children's Hospital of Chicago and Northwestern Memorial Hospital
Chicago, Illinois, United States, 60614