Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

Phase 2

Completed

• Conditions: Infant, Small for Gestational Age; Bronchopulmonary Dysplasia; Infant, Newborn; Infant, Low Birth Weight; Infant, Premature
• Interventions: Drug: Exosurf; Drug: Survanta

• Registration Number: NCT01203358
• Lead Sponsor: NICHD Neonatal Research Network

Brief Summary

The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.

Detailed Description

The NICHD Neonatal Research Network conducted a randomized trial at 11 centers comparing the efficacy of two surfactants -- Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories) -- for the treatment of neonatal respiratory distress syndrome. Newborn infants with birth weights of 501-1500g with respiratory distress syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992. Infants were randomly assigned to receive up to four intratracheal doses of either Exosurf Neonatal or Survanta.

Study Timeline

• Study Start: 1991-01
• Primary Completion: 1992-01
• Study Completion: 1992-01
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 617

Inclusion Criteria

• Newborn infants weighing 501 to 1500 gm with respiratory distress syndrome were receiving assisted ventilation with 30% oxygen or more

Exclusion Criteria

• Less than 6 hours of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surfactant 1	Exosurf	Exosurf Neonatal (Burroughs Wellcome Co.)
Surfactant 2	Survanta	Survanta (Ross Laboratories)

Primary Outcome Measures

Name	Time	Method
Death or bronchopulmonary dysplasia	28 days of life

Secondary Outcome Measures

Name	Time	Method
Average fraction of inspired oxygen (FIO2)	72 hours after treatment
Mean airway pressure (MAP)	72 hours after treatment

Trial Locations

Locations (13)

University of Vermont; 🇺🇸 Burlington, Vermont, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States

Cincinnati Children's Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

University of Tennessee; 🇺🇸 Memphis, Tennessee, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States