Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
- Conditions
- Bronchopulmonary Dysplasia
- Interventions
- Drug: PlaceboDrug: Inhaled Nitric Oxide
- Registration Number
- NCT00931632
- Lead Sponsor
- Mallinckrodt
- 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 support at any point during days 5 to 14 after birth may benefit from treatment with iNO.
- 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 starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome measure will be survival without BPD at 36 weeks gestational age using a physiologic assessment of BPD.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 451
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Nitrogen Placebo Inhaled Nitric Oxide Inhaled Nitric Oxide Inhaled Nitric Oxide
- Primary Outcome Measures
Name Time Method Survival Without BPD at 36 Weeks Baseline, 36 weeks PMA
- Secondary Outcome Measures
Name Time Method Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia Through hospital discharge, an average of 105 days for placebo and 108 days for INO Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason Through hospital discharge, an average of 105 days for placebo and 108 days for INO Systemic Use of Postnatal Corticosteroids for Any Medical Reason Through hospital discharge, an average of 105 days for placebo and 108 days for INO Days of Airway Pressure Support - Intent-to-treat Population Through hospital discharge, an average of 105 days for placebo and 108 days for INO Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.
Length of Birth Hospitalization Through hospital discharge, an average of 105 days for placebo and 108 days for INO Number of Days of Oxygen Use Through hospital discharge, an average of 105 days for placebo and 108 days for INO Severity of Bronchopulmonary Dysplasia 36 weeks Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.
Trial Locations
- Locations (33)
Saint Francis Children's Hospital
🇺🇸Tulsa, Oklahoma, United States
Sharp Mary Birch Hospital for Women and Newborns
🇺🇸San Diego, California, United States
Winnie Palmer Hospital for Women and Babies
🇺🇸Orlando, Florida, United States
Loma Linda University School of Medicine
🇺🇸Loma Linda, California, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Jersey Shore University Medical Center
🇺🇸Neptune City, New Jersey, United States
Maria Fareri Children's Hospital at Westchester Medical Center
🇺🇸Valhalla, New York, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Advocate Lutheran General Children's Hospital
🇺🇸Park Ridge, Illinois, United States
University of Louisville School of Medicine
🇺🇸Louisville, Kentucky, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Mercy Children's Hospital
🇺🇸Toledo, Ohio, United States
Wheaton Franciscan Healthcare
🇺🇸Milwaukee, Wisconsin, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Rady Children's Hospital of San Diego
🇺🇸San Diego, California, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
WakeMed Faculty Physicians, Neonatology
🇺🇸Raleigh, North Carolina, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Children's Corporate Center, Division of Neonatology
🇺🇸Wauwatosa, Wisconsin, United States
Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
University of So Florida College of Medicine
🇺🇸Tampa, Florida, United States
Sanford Children's Hospital
🇺🇸Sioux Falls, South Dakota, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Montefiore Medical Center
🇺🇸The Bronx, New York, United States