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Home > "I" Clinical Trials Conditions > Inhaled NO in Prevention of Chronic Lung Disease  Inhaled NO in Prevention of Chronic Lung Disease
Inhaled NO in Prevention of Chronic Lung Disease
For Condition: Bronchopulmonary Dysplasia,Lung Diseases
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To test the hypothesis that low-dose inhaled nitric oxide administered to preterm infants who continue to require mechanical ventilation at 14 days of age will reduce the incidence of chronic lung disease.
Details: BACKGROUND: Respiratory morbidity, particularly chronic lung disease (CLD), remains a major cause of long-term morbidity and mortality for preterm infants. Although surfactant replacement has decreased acute respiratory morbidity and mortality, it has not reduced the incidence of CLD. A number of other approaches, including antenatal thyrotropin releasing hormone in conjunction with corticosteroids, postnatal steroid administration, as well as administration of Vitamin E, diuretics, and bronchodilators, have not resulted in clinically important decreases in CLD. Infants with the most severe CLD go on to develop findings suggestive of pulmonary hypertension with cor pulmonale. There is preliminary evidence in the preterm infant with severe chronic lung disease that low-dose inhaled nitric oxide may significantly attenuate the disease and decrease mortality. DESIGN NARRATIVE: The multi-center, controlled and blinded trial investigates the hypothesis that low-dose inhaled nitric oxide administered to preterm infants between 500 and 1250 grams birth weight who continue to require mechanical ventilation at 10 days of age will increase survival without chronic lung disease (CLD) at 36 weeks post menstrual age. Secondary outcomes are duration of ventilation, oxygen requirement and duration of hospitalization. In addition, that there will be expected improvement in infant respiratory status (ventilatory support, airway resistance and compliance) associated with inhaled nitric oxide treatment. Indicators of inflammation and oxidant stress will be assessed by measurements of specific cytokines and protein modifications in tracheal aspirate and plasma samples, respectively. The safety of this therapy will be evaluated by assessing toxicity as measured by clinical bleeding, including intraventricular hemorrhage as well as the incidence of other morbidities of the preterm infant (necrotizing enterocolitis, retinopathy of prematurity and infection) and assessing neurodevelopmental outcome through two years of age. A total of 800 infants will be randomized to either inhaled NO or placebo. In summary, this clinical trial will assess the efficacy and safety of inhaled nitric oxide for amelioration of a major disease of premature infants.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry Criteria: Preterm infants who are 500-1250 grams at birth and who require mechanical ventilation at 10 to 21 days of age. Exclusions include congenital heart disease or pulmonary abnormalities, including a patent ductus arteriosus, ventilation solely for apnea, small-for-gestational age, or clinical bleeding.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertaBallard, , Children's Hospital of Philadelphia
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Roberta Ballard 215-590-1653
Additional Information:
Study ID Numbers: 92;
Study Start Date: March 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000548
Other Bronchopulmonary Dysplasia Studies:
1. Multicenter Asthma Research Collaboration
2. A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)
3. Sleep Apnea in Elderly Male Twins
4. Clinical Trial of Acid Reflux Therapy in Asthma
5. Lymphangioleiomyomatosis (LAM) Registry
Related Studies:
Other Bronchopulmonary Dysplasia Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Inhaled NO in Prevention of Chronic Lung Disease
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