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Trial NCT00000548

Resource URI: http://static.linkedct.org/resource/trials/NCT00000548
linkedct:brief_title Inhaled NO in Prevention of Chronic Lung Disease
linkedct:condition <http://static.linkedct.org/resource/condition/1950>
linkedct:condition <http://static.linkedct.org/resource/condition/7483>
linkedct: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.
linkedct:description 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 480 infants were 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 1 Year
linkedct:eligibility_minimum_age N/A
linkedct:end_date February 2006
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000548
rdfs:label Trial NCT00000548
linkedct:lastchanged_date August 25, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000548
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 92
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/51187>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000548>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/18306>
linkedct:reference <http://static.linkedct.org/resource/reference/24237>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date March 2000
linkedct:study_design Prevention, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date August 2005