Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00955487
First received: August 6, 2009
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Bronchopulmonary Dysplasia
Drug: Inhaled Nitric Oxide (iNO)
Drug: Nitrogen (placebo)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Non-invasive Inhaled Nitric Oxide in Premature Newborns

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Combined endpoint of bronchopulmonary dysplasia and mortality [ Time Frame: Week 36 or earlier, if participants are discharged from the hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary hypertension [ Time Frame: Week 36 or earlier, if participants are discharged from the hospital ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: January 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Nitric Oxide (iNO)
Participants 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.
Drug: Inhaled Nitric Oxide (iNO)
iNO will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
Placebo Comparator: Nitrogen (placebo)
Participants will receive nitrogen (placebo) while in the hospital.
Drug: Nitrogen (placebo)
Nitrogen will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).

Detailed Description:

BPD is a serious lung condition that primarily affects premature newborns and newborns with low birth weights. iNO has been proven to be a safe and effective treatment for pulmonary hypertension and hypoxemic respiratory failure—both of which are abnormal lung conditions—in full-term newborns. However, in babies born prematurely, the effects of iNO on lung function are not well defined. Also, previous studies have mainly examined whether iNO reduces the incidence of BPD in newborns who are on mechanical ventilation. However, intubation and mechanical ventilation of premature newborns is now increasingly being avoided, and non-invasive support, including the use of nasal continuous positive airway pressure (NCPAP), is being used. Early treatment with low-dose iNO may reduce the incidence of BPD in premature newborns who do not require mechanical ventilation and intubation after delivery. The purpose of this study is to determine if low-dose, non-invasive iNO reduces the risk of BPD, pulmonary hypertension, and death in premature newborns who do not require mechanical ventilation.

This study will enroll premature newborns who require extra oxygen but do not require intubation or mechanical ventilation for respiratory failure in the first 72 hours of life. Participants will be randomly assigned to receive low-dose, non-invasive iNO or nitrogen (placebo) during their hospital stay. While hospitalized, participants' heart rate, blood oxygen level breathing rate, blood pressure, and medications will be monitored, and blood collection will occur at various times. Monitoring will continue until participants are 30 weeks corrected gestational age or for at least 14 days if participants are born at 29 weeks or more. All participants will undergo an ultrasound of the head when they are 7 days, 28 days, and 36 weeks of age. They will undergo an echocardiogram, which is an ultrasound of the heart, at 7 and 21 days of age and 4 weeks before the original expected due date. A chest x-ray will be performed before hospital discharge, and a breathing status test will be performed either 4 weeks before participants' original expected due date or before hospital discharge. Follow-up study visits will occur at Years 1 and 2, and will include a physical examination and developmental and behavioral testing. Another echocardiogram will also be performed at the Year 1 visit.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955487

Contacts
Contact: John Kinsella, MD 303-724-2853 John.Kinsella@ucdenver.edu
Contact: Gary Cutter, PhD 205-975-5048 cutter@prodigy.net

Locations
United States, Alabama
University of Alabama at Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35242
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92123
Contact: Neil Finer, MD         
United States, Colorado
Children's Hospital and University Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: John Kinsella, MD    303-724-2853    John.Kinsella@ucdenver.edu   
Contact: Lucy Fashaw, RN, BSN    720-777-6745    Lucy.Fashaw@ucdenver.edu   
United States, Illinois
Children's Memorial Hospital and Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Contact: Robin Steinhorn, MD         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Leif D Nelin, MD, FAAP         
United States, Tennessee
Vanderbilt Children's Hospital Recruiting
Nashville, Tennessee, United States, 37232
Contact: William F Walsh, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: John Kinsella, MD Chidlren's Hospital and University of Colorado Hospital
  More Information

No publications provided

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00955487     History of Changes
Other Study ID Numbers: 667, 5 P50 HL084923-030001
Study First Received: August 6, 2009
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Premature Newborns
Inhaled Nitric Oxide

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bronchopulmonary Dysplasia
Premature Birth
Ventilator-Induced Lung Injury
Lung Injury
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014