Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants

Completed · Phase 3 · Has a placebo group

Conditions studied: Bronchopulmonary Dysplasia

In brief

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.

Key facts

Study ID

NCT00931632

Run by

Mallinckrodt

People needed

451

Starts

2009-11-01

Expected to finish

2014-05-01

Last updated by the study team

2017-12-04

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Loma Linda University School of Medicine — Loma Linda, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• Rady Children's Hospital of San Diego — San Diego, California, United States
• Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Winnie Palmer Hospital for Women and Babies — Orlando, Florida, United States
• University of So Florida College of Medicine — Tampa, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Advocate Lutheran General Children's Hospital — Park Ridge, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Louisville School of Medicine — Louisville, Kentucky, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Maria Fareri Children's Hospital at Westchester Medical Center — Valhalla, New York, United States
• WakeMed Faculty Physicians, Neonatology — Raleigh, North Carolina, United States
• Mercy Children's Hospital — Toledo, Ohio, United States
• Saint Francis Children's Hospital — Tulsa, Oklahoma, United States
• Greenville Memorial Hospital — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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