Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
3 other identifiers
interventional
124
1 country
6
Brief Summary
Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns. The condition involves abnormal development of lung tissue and is characterized by inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce the incidence of BPD and another commonly associated condition called pulmonary hypertension, which is high blood pressure in the vessels carrying blood to the lungs.. This study will determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary hypertension, and death in premature newborns.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2007
Longer than P75 for phase_2
6 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
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
May 23, 2017
CompletedJune 15, 2017
May 1, 2017
7.5 years
August 6, 2009
April 14, 2017
May 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality
Number of participants that developed bronchopulmonary dysplasia and/or that died
Week 36 or earlier, if participants are discharged from the hospital
Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight
Number of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams)
Randomization to discharge
Secondary Outcomes (9)
Severity of Bronchopulmonary Dysplasia (BPD)
36 weeks corrected gestational age
Need for Mechanical Ventilation
Anytime after randomization up to 36 weeks corrected gestational age
Total Ventilation Days
After randomization up until hospital discharge
Necrotizing Enterocolitis (NEC)
After randomization through hospital discharge
Symptomatic PDA Requiring Medical Treatment
From randomization until discharge
- +4 more secondary outcomes
Other Outcomes (1)
Days in Hospital
From birth to hospital discharge
Study Arms (2)
Inhaled Nitric Oxide (iNO)
EXPERIMENTALParticipants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Nitrogen (placebo)
PLACEBO COMPARATORParticipants will receive nitrogen (placebo) while in the hospital.
Interventions
iNO will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
Nitrogen will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
Eligibility Criteria
You may qualify if:
- Birth weight of 500-1250 grams and gestational age of less than 34 weeks
- Age at enrollment is less than 72 hours
- Supplemental oxygen or 21% requirement by nasal cannula or NCPAP only
You may not qualify if:
- Presence of structural heart disease (other than patent ductus arteriosus, atrial septal defect less than 1 cm, or muscular ventricular septal defect less than 2 mm)
- Presence of lethal congenital anomaly
- Participating in another concurrent experimental study
- Requires mechanical ventilation in the first 72 hours of life (patients are not excluded if they are intubated briefly but they must be extubated at the time of consent and study entry prior to 72 hours of life)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Alabama at Birmingham
Birmingham, Alabama, 35242, United States
University of California San Diego
San Diego, California, 92123, United States
Children's Hospital and University Colorado Hospital
Aurora, Colorado, 80045, United States
Anne and Robert H. Lurie Children's Hospital of Chicago and Northwestern Memorial Hospital
Chicago, Illinois, 60614, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232, United States
Related Publications (1)
Kinsella JP, Cutter GR, Steinhorn RH, Nelin LD, Walsh WF, Finer NN, Abman SH. Noninvasive inhaled nitric oxide does not prevent bronchopulmonary dysplasia in premature newborns. J Pediatr. 2014 Dec;165(6):1104-1108.e1. doi: 10.1016/j.jpeds.2014.06.018. Epub 2014 Jul 22.
PMID: 25063725DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John Kinsella
- Organization
- University of Colorado School of Medicine/Children's Hospital Colorado
Study Officials
- PRINCIPAL INVESTIGATOR
John Kinsella, MD
Chidlren's Hospital and University of Colorado Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 10, 2009
Study Start
January 1, 2007
Primary Completion
July 1, 2014
Study Completion
December 1, 2014
Last Updated
June 15, 2017
Results First Posted
May 23, 2017
Record last verified: 2017-05