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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00006401 |
To determine whether or not inhaled nitric oxide (iNO) safely decreases the incidence of chronic lung disease (CLD) in premature infants.
Condition | Intervention | Phase |
---|---|---|
Lung Diseases Bronchopulmonary Dysplasia |
Procedure: Mechanical Ventilation |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | Inhaled NO for the Prevention of Chronic Lung Disease |
Estimated Enrollment: | 793 |
Study Start Date: | September 2000 |
Study Completion Date: | October 2007 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
BACKGROUND:
Despite advances in medical, nursing, and respiratory care, CLD affects up to 50 percent of premature infants. As a result, nearly 50,000 infants in the United States develop CLD. It is desirable to investigate therapies that decrease the incidence of CLD because it is associated with failure to thrive, developmental delay, increased risk of pulmonary infection, reactive airway disease, pulmonary hypertension, and death.
DESIGN NARRATIVE:
This is a randomized, double-blind, placebo-controlled, multi-center study. Three specific hypotheses will be tested: 1) iNO reduces the incidence of CLD; 2) iNO reduces serum and lung (tracheal aspirate) markers of inflammation; and 3) iNO does not increase the incidence of intraventricular hemorrhage in premature neonates. The primary endpoint is survival without CLD (defined as continued oxygen requirement) at 36 weeks post conceptional age.
A total of 793 premature newborns will be enrolled from 14 centers within 48 hours of birth. They will be randomly assigned to receive either placebo or iNO at 5 ppm until the breathing tube can be safely removed or after 21 days. The iNO will be delivered by an INOvent delivery system in such a way that physicians and nurses will not know which treatment each participant is receiving. Management strategies for aspects of patient care including mechanical ventilation, surfactant administration, fluid administration, and steroid use will be determined by physicians at each center. Serial cranial ultrasounds and methemoglobin levels will be monitored to determine adverse events. The first 200 patients will have serial blood samples and tracheal aspirates obtained for measurements of inflammatory mediators, including interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), endothelin-1, myeloperoxidase, neutrophil counts (tracheal aspirates), and endothelin-1 (blood). Participants will be seen at 12 and 24 months of age to monitor the long-term effects on the cardiopulmonary or neurologic systems. At these visits, a health questionnaire will be administered and Bayley II scales of infant development will be completed.
Ages Eligible for Study: | up to 1 Year |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
St. Joseph's Hospital | |
Phoenix, Arizona, United States, 85013 | |
United States, California | |
Loma Linda University Medical Center | |
Loma Linda, California, United States, 92350 | |
Univeristy of Southern California/Good Samaritan Hospital | |
Los Angeles, California, United States, 90033 | |
United States, Colorado | |
Children's Hospital | |
Denver, Colorado, United States, 80218-1088 | |
United States, Connecticut | |
University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06030 | |
United States, Iowa | |
University of Iowa Hospital & Clinics | |
Iowa City, Iowa, United States, 52242 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
University of North Carolina Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Oklahoma | |
Children's Hospital of Oklahoma | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
Magee-Women's Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
Pennsylvania Hospital | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Utah | |
Utah Valley Regional Medical Center | |
Provo, Utah, United States, 84604 |
Study Chair: | John P. Kinsella, MD | Children's Hospital |
Study ID Numbers: | 135, U01 HL64857 |
Study First Received: | October 12, 2000 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00006401 |
Health Authority: | United States: Federal Government |
Nitric Oxide Bronchopulmonary dysplasia Bronchopulmonary Dysplasia Respiratory Tract Diseases |
Lung Diseases Infant, Newborn, Diseases Infant, Premature, Diseases |