Inhaled NO in Prevention of Chronic Lung Disease

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Brief Title

Inhaled NO in Prevention of Chronic Lung Disease


Brief 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.
    

Detailed 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Survival without chronic lung disease (CLD)


Condition

Bronchopulmonary Dysplasia

Intervention

mechanical ventilation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure


Start Date

March 2000

Completion Date

February 2006


Eligibility 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.
      

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

Roberta Ballard, , 



Administrative Informations


NCT ID

NCT00000548

Organization ID

92

Secondary IDs

U01HL062514


Study Sponsor

University of California, San Francisco

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Roberta Ballard, , Children's Hospital of Philadelphia


Verification Date

March 2015