Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants
Inhaled NO for the Prevention of Chronic Lung Disease
2 other identifiers
interventional
793
1 country
14
Brief Summary
To determine whether or not inhaled nitric oxide (iNO) safely decreases the incidence of chronic lung disease (CLD) in premature infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2000
Longer than P75 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
October 12, 2000
CompletedFirst Posted
Study publicly available on registry
October 13, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedOctober 6, 2015
October 1, 2015
5 years
October 12, 2000
October 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Participant's survival without CLD
(measured at 36 weeks after birth)
Study Arms (2)
Inhaled Nitric Oxide (iNO)
EXPERIMENTALNitric Oxide study gas will be initiated at 5 ppm using the INOvent delivery system. The delivery system provides for masked delivery of the treatment gas. This dose will be used for a 21-day period or until extubation.
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Weighing between 500 to 1250 grams at birth
- Gestational age of less than 34 weeks
- Less than 48 hours old
- Respiratory failure on mechanical ventilation
- Absence of structural heart disease (PDA, ASD less than 1 cm, or VSD less than 2 mm are permitted if known prior to study entry)
- Absence of lethal congenital anomaly
You may not qualify if:
- Concurrent participation in another experimental study (observational studies will be allowed with prior approval by the Steering Committee and Data and Safety Monitoring Board)
- Active pulmonary hemorrhage
- Unevaluated pneumothorax
- High frequency jet ventilation
- Expected short duration of ventilation (less than 48 hours from birth)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
St. Joseph's Hospital
Phoenix, Arizona, 85013, United States
Loma Linda University Medical Center
Loma Linda, California, 92350, United States
Univeristy of Southern California/Good Samaritan Hospital
Los Angeles, California, 90033, United States
Children's Hospital
Denver, Colorado, 80218-1088, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
University of Iowa Hospital & Clinics
Iowa City, Iowa, 52242, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Magee-Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Related Publications (3)
Kinsella JP, Cutter GR, Walsh WF, Gerstmann DR, Bose CL, Hart C, Sekar KC, Auten RL, Bhutani VK, Gerdes JS, George TN, Southgate WM, Carriedo H, Couser RJ, Mammel MC, Hall DC, Pappagallo M, Sardesai S, Strain JD, Baier M, Abman SH. Early inhaled nitric oxide therapy in premature newborns with respiratory failure. N Engl J Med. 2006 Jul 27;355(4):354-64. doi: 10.1056/NEJMoa060442.
PMID: 16870914RESULTMourani PM, Kinsella JP, Clermont G, Kong L, Perkins AM, Weissfeld L, Cutter G, Linde-Zwirble WT, Abman SH, Angus DC, Watson RS; Prolonged Outcomes after Nitric Oxide (PrONOx) Investigators. Intensive care unit readmission during childhood after preterm birth with respiratory failure. J Pediatr. 2014 Apr;164(4):749-755.e3. doi: 10.1016/j.jpeds.2013.11.062. Epub 2013 Dec 31.
PMID: 24388320DERIVEDWatson RS, Clermont G, Kinsella JP, Kong L, Arendt RE, Cutter G, Linde-Zwirble WT, Abman SH, Angus DC; Prolonged Outcomes After Nitric Oxide Investigators. Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year. Pediatrics. 2009 Nov;124(5):1333-43. doi: 10.1542/peds.2009-0114. Epub 2009 Oct 19.
PMID: 19841128DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John P. Kinsella, MD
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2000
First Posted
October 13, 2000
Study Start
September 1, 2000
Primary Completion
September 1, 2005
Study Completion
October 1, 2007
Last Updated
October 6, 2015
Record last verified: 2015-10