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Clinical Interventions in Respiratory Distress Syndrome and Neonatal Lung Injury - SCOR in Lung Biology and Diseases in Infants and Children
This study has been completed.
Study NCT00005683   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes

May 25, 2000
June 23, 2005
December 1986
 
 
 
Complete list of historical versions of study NCT00005683 on ClinicalTrials.gov Archive Site
 
 
 
Clinical Interventions in Respiratory Distress Syndrome and Neonatal Lung Injury - SCOR in Lung Biology and Diseases in Infants and Children
 

To conduct clinical interventions directed at neonatal lung disease and injury, with a focus on infants having surfactant-deficiency or inactivation as a component of pathophysiology. A major emphasis was on the surfactant-deficient Respiratory Distress Syndrome (RDS) of premature infants, and on acute neonatal respiratory failure in term infants with pulmonary edema and potential surfactant inactivation (ARDS-related).

BACKGROUND:

The study was a subproject within a Specialized Center of Research (SCOR) in Lung Biology and Diseases in Infants and Children. The clinical interventions studied had significance for respiratory distress syndrome of the newborn and for bronchopulmonary dysplasia, which is the chronic lung disorder of fibrosis, alveolar loss and reactive airway disease that often follows pulmonary disease requiring treatment with oxygen and mechanical ventilation in the newborn period.

DESIGN NARRATIVE:

A series of randomized, controlled trials/studies were conducted. In the first clinical study, full term infants with severe respiratory pathology where surfactant inactivation was important were assigned randomly to exogenous surfactant versus control groups to determine if surfactant was efficacious and safe in this kind of lung injury. In the second study, infants of less than 29 weeks gestation received prophylactic exogenous surfactant, but were assigned randomly to receive it immediately following birth or after initial stabilization at 10-15 minutes, to address a then critical current issue in surfactant therapy for RDS. In the third study, infants who had moderate RDS despite exogenous surfactant therapy were randomly assigned to high frequency jet or conventional ventilation groups to determine if this mode of ventilation therapy would reduce barotrauma and the incidence and/or severity of bronchopulmonary dysplasia (BPD). In addition to these three clinical trials, another study involved therapy using superoxide dismutase (SOD) along with surfactant as a multi-modal approach treating premature infants with RDS and lung injury secondary to hyperoxia and mechanical ventilation. This study depended on results of animal studies with SOD in Project 5. Finally, the study addressed the long term evaluation and surveillance of survival, rehospitalizations, health status, pulmonary sequelae, and school performance of those infants enrolled in the randomized clinical trials, as necessary for long-term outcome assessments.

 
Observational
Retrospective Study
  • Lung Diseases
  • Respiratory Distress Syndrome
  • Bronchopulmonary Dysplasia
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
November 1997
 

No eligibility criteria

Both
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005683
 
4094
National Heart, Lung, and Blood Institute (NHLBI)
 
 
National Heart, Lung, and Blood Institute (NHLBI)
September 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP