Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
1 other identifier
interventional
451
2 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2009
Longer than P75 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
August 11, 2015
CompletedDecember 4, 2017
October 1, 2017
3.5 years
July 1, 2009
July 16, 2015
October 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival Without BPD at 36 Weeks
Baseline, 36 weeks PMA
Secondary Outcomes (7)
Days of Airway Pressure Support - Intent-to-treat Population
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Length of Birth Hospitalization
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 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
- +2 more secondary outcomes
Study Arms (2)
Inhaled Nitric Oxide
EXPERIMENTALInhaled Nitric Oxide
Placebo
PLACEBO COMPARATORNitrogen Placebo
Interventions
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.
Nitrogen gas will be administered in the same manner as the experimental drug.
Eligibility Criteria
You may qualify if:
- Preterm infants who are:
- to 1250 grams at birth
- \< 30 weeks gestational age
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (33)
Phoenix Children's Hospital
Phoenix, Arizona, 85006, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Loma Linda University School of Medicine
Loma Linda, California, 92354, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
Rady Children's Hospital of San Diego
San Diego, California, 92123, United States
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Winnie Palmer Hospital for Women and Babies
Orlando, Florida, 32806, United States
University of So Florida College of Medicine
Tampa, Florida, 33606, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Advocate Lutheran General Children's Hospital
Park Ridge, Illinois, 60068, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Louisville School of Medicine
Louisville, Kentucky, 40202, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Maria Fareri Children's Hospital at Westchester Medical Center
Valhalla, New York, 10595, United States
WakeMed Faculty Physicians, Neonatology
Raleigh, North Carolina, 27610, United States
Mercy Children's Hospital
Toledo, Ohio, 43608, United States
Saint Francis Children's Hospital
Tulsa, Oklahoma, 74136, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Sanford Children's Hospital
Sioux Falls, South Dakota, 57117, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Wheaton Franciscan Healthcare
Milwaukee, Wisconsin, 53210, United States
Children's Corporate Center, Division of Neonatology
Wauwatosa, Wisconsin, 53226, United States
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
Centre Hospitalier Universitaire de Quebec
Québec, G1V 4G2, Canada
Related Publications (1)
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.
PMID: 28973344RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lawrence Hill
- Organization
- Mallinckrodt
Study Officials
- STUDY DIRECTOR
James Baldassarre, MD
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2009
First Posted
July 2, 2009
Study Start
November 1, 2009
Primary Completion
May 1, 2013
Study Completion
May 1, 2014
Last Updated
December 4, 2017
Results First Posted
August 11, 2015
Record last verified: 2017-10