Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
NCT ID: NCT00931632
Last Updated: 2017-12-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
451 participants
INTERVENTIONAL
2009-11-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Inhaled Nitric Oxide
Inhaled Nitric Oxide
Inhaled Nitric Oxide
Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
Placebo
Nitrogen Placebo
Placebo
Nitrogen gas will be administered in the same manner as the experimental drug.
Interventions
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Inhaled Nitric Oxide
Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
Placebo
Nitrogen gas will be administered in the same manner as the experimental drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. 500 to 1250 grams at birth
2. \< 30 weeks gestational age
3. 5 to 14 days of age (inclusive) at the time of entry
4. 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 Criteria
2. Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
3. Subjects who are dependent on right to left shunting to maintain the systemic circulation
4. Preterm infants who received prior iNO therapy
5. Use of another investigational agent
5 Days
14 Days
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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James Baldassarre, MD
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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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
Sanford Children's Hospital
Sioux Falls, South Dakota, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Wheaton Franciscan Healthcare
Milwaukee, Wisconsin, United States
Children's Corporate Center, Division of Neonatology
Wauwatosa, Wisconsin, United States
University of Calgary
Calgary, Alberta, Canada
Centre Hospitalier Universitaire de Quebec
Québec, , Canada
Countries
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References
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Hasan SU, Potenziano J, Konduri GG, Perez JA, Van Meurs KP, Walker MW, Yoder BA; Newborns Treated With Nitric Oxide (NEWNO) Trial Group. Effect of Inhaled Nitric Oxide on Survival Without Bronchopulmonary Dysplasia in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017 Nov 1;171(11):1081-1089. doi: 10.1001/jamapediatrics.2017.2618.
Related Links
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Other Identifiers
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IK-3001-BPD-301
Identifier Type: -
Identifier Source: org_study_id