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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.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005683
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: September 2002
  Purpose

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).


Condition
Lung Diseases
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia

Study Type: Observational
Study Design: Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: December 1986
Estimated Study Completion Date: November 1997
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00005683     History of Changes
Other Study ID Numbers: 4094
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Lung Diseases
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on November 19, 2014