Surfactant 1: Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

Sponsor

NICHD Neonatal Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT01203358

Collaborator

(none)

617

Enrollment

Locations

Arms

Duration (Months)

47.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Bronchopulmonary Dysplasia	Drug: Exosurf Drug: Survanta	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

617 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome

Study Start Date :

Jan 1, 1991

Actual Primary Completion Date :

Jan 1, 1992

Actual Study Completion Date :

Jan 1, 1992

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Surfactant 1 Exosurf Neonatal (Burroughs Wellcome Co.)	Drug: Exosurf Infants received up to four intratracheal doses of the surfactant. Other Names: Exosurf Neonatal (Burroughs Wellcome Co.)
Active Comparator: Surfactant 2 Survanta (Ross Laboratories)	Drug: Survanta Infants received up to four intratracheal doses of the surfactant. Other Names: Survanta (Ross Laboratories)

Arm

Intervention/Treatment

Active Comparator: Surfactant 1

Exosurf Neonatal (Burroughs Wellcome Co.)

Drug: Exosurf

Infants received up to four intratracheal doses of the surfactant.

Other Names:

Exosurf Neonatal (Burroughs Wellcome Co.)

Active Comparator: Surfactant 2

Survanta (Ross Laboratories)

Drug: Survanta

Infants received up to four intratracheal doses of the surfactant.

Other Names:

Survanta (Ross Laboratories)

Outcome Measures

Primary Outcome Measures

Death or bronchopulmonary dysplasia [28 days of life]

Secondary Outcome Measures

Average fraction of inspired oxygen (FIO2) [72 hours after treatment]
Mean airway pressure (MAP) [72 hours after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304
2	Yale University	New Haven	Connecticut	United States	06504
3	George Washington University	Washington	District of Columbia	United States	20052
4	University of Miami	Miami	Florida	United States	33136
5	Emory University	Atlanta	Georgia	United States	30303
6	Indiana University	Indianapolis	Indiana	United States	46202
7	Wayne State University	Detroit	Michigan	United States	48201
8	University of New Mexico	Albuquerque	New Mexico	United States	87131
9	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States	45267
10	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
11	University of Tennessee	Memphis	Tennessee	United States	38163
12	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235
13	University of Vermont	Burlington	Vermont	United States	05405

Sponsors and Collaborators

NICHD Neonatal Research Network

Investigators

Study Director: Jeffrey D. Horbar, MD, University of Vermont
Principal Investigator: Elizabeth C. Wright, PhD, George Washington University
Principal Investigator: Avroy A. Fanaroff, MD, Case Western Reserve University
Principal Investigator: Sheldon B. Korones, MD, University of Tennessee
Principal Investigator: Seetha Shankaran, MD, Wayne State University
Principal Investigator: Charles R. Bauer, MD, University of Miami
Principal Investigator: Jon E. Tyson, MD MPH, University of Texas
Principal Investigator: James A. Lemons, MD, Indiana University
Principal Investigator: Edward F. Donovan, MD, Children's Hospital Medical Center, Cincinnati
Principal Investigator: Barbara J. Stoll, MD, Emory University
Principal Investigator: David K. Stevenson, MD, Stanford University
Principal Investigator: LuAnn Papile, MD, University of New Mexico