Status:
COMPLETED
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
Lead Sponsor:
Mallinckrodt
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
5-14 years
Phase:
PHASE3
Brief 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 suppo...
Detailed Description
Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT00931632
Start Date
November 1 2009
End Date
May 1 2014
Last Update
December 4 2017
Active Locations (33)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85006
2
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
3
Loma Linda University School of Medicine
Loma Linda, California, United States, 92354
4
Children's Hospital of Orange County
Orange, California, United States, 92868