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Human Surfactant Treatment of Respiratory Distress Syndrome Bicenter Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000570
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : December 13, 2013
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE October 27, 1999
First Posted Date  ICMJE October 28, 1999
Last Update Posted Date December 13, 2013
Study Start Date  ICMJE January 1986
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Surfactant Treatment of Respiratory Distress Syndrome Bicenter Trial
Official Title  ICMJE Not Provided
Brief Summary To determine if surfactant administration at birth in infants at high risk for respiratory distress syndrome (RDS) modified the clinical course of the syndrome.
Detailed Description

BACKGROUND:

Respiratory distress syndrome affects more than 40,000 infants annually in the United States. The overall mortality rate exceeds 20 percent and in infants weighing less than 1500 grams at birth, RDS is responsible for or contributes to the 30-70 percent mortality, depending on birthweight. The present customary treatment of RDS with intermittent mandatory ventilation is accompanied by sequelae such as extra-alveolar air leaks, intraventricular hemorrhage, and bronchopulmonary dysplasia in approximately 50 percent of survivors.

The respiratory distress syndrome of the newborn is a disorder in which the pulmonary surfactant is deficient. It has not been possible to completely replace natural components of surfactant with synthetic components and achieve a mixture which functions physiologically like pulmonary surfactant. Therefore, studies of replacement therapy for surfactant deficiency have used complete natural surfactants or derivatives of natural surfactant which contain the defined components of surfactant. The surfactant used in the clinical trial was derived from human amniotic fluid.

Two basic different strategies for surfactant treatment of respiratory distress syndrome have emerged: prophylactic, or preventilatory, treatment at or shortly after birth versus rescue treatment after the initiation of mechanical ventilation in instances of clinically confirmed respiratory distress syndrome. Although treatment at birth has the theoretic advantage of delivering surfactant more uniformly to the airways before mechanical ventilation, it has the disadvantages of delaying physiologic stabilization after birth and resulting in unnecessary treatment, at considerable cost, of 20 percent to 40 percent of infants born at or less than 30 weeks of gestation. Rescue therapy permits early physiologic stabilization and confirmation of respiratory distress syndrome, but with the theoretic disadvantages of early lung injury from mechanical ventilation in the surfactant-deficient lung and less uniform surfactant distribution. Previous comparative trials have been biased by incomplete study enrollment and inclusion of infants in preventilation treatment groups without evidence of surfactant deficiency or immaturity. In addition, outcomes have varied in placebo-treated infants.

DESIGN NARRATIVE:

Randomized, placebo-controlled. Singleton infants were assigned to receive a placebo (air), prophylactic surfactant treatment given intratracheally, or rescue surfactant treatment. Multiple birth infants received either prophylactic or rescue treatment. Of 282 potentially eligible infants, 246 received treatments at birth and 200 had respiratory distress syndrome and received the full course of surfactant therapy. Preterm infants randomly assigned to receive prophylactic treatment received surfactant soon after birth; those assigned to receive rescue surfactant had instillation at a mean age of 220 minutes if the lecithin-sphingomyelin ratio was _ 2.0 and no phosphatidylglycerol was detected in either amniotic fluid or initial airway aspirate, oxygen requirements were a fraction of inspired oxygen of > 0.5 and mean airway pressure was _ 7 cm H20 from 2 to 12 hours after birth. Up to four treatment doses were permitted within 48 hours; approximately 60 percent of surfactant-treated infants required two or more doses. Endpoints included the mortality rate at 28 days of age, the incidence of bronchopulmonary dysplasia at 28 days after birth and at 38 weeks to adjust for differences in gestational age, the incidence of pulmonary air leaks, and the severity of respiratory distress syndrome as assessed by requirement for supplemental oxygen and mechanical ventilation.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Prevention
Condition  ICMJE
  • Lung Diseases
  • Respiratory Distress Syndrome
Intervention  ICMJE Drug: pulmonary surfactant
Study Arms  ICMJE Not Provided
Publications * Hallman M, Merritt TA, Bry K, Berry C. Association between neonatal care practices and efficacy of exogenous human surfactant: results of a bicenter randomized trial. Pediatrics. 1993 Mar;91(3):552-60.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 1990
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Boy and girl preterm infants 24-29 weeks of gestational age and 500-1400 grams birthweight.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000570
Other Study ID Numbers  ICMJE 208
5R01HL035036 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Thurman Merritt University of California, San Diego
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date January 2000

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