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

Primary Purpose

Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exosurf
Survanta
Sponsored by
NICHD Neonatal Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Newborn focused on measuring NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Respiratory distress syndrome, Surfactant

Eligibility Criteria

undefined - 6 Hours (Child)All SexesDoes not accept 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

Sites / Locations

  • Stanford University
  • Yale University
  • George Washington University
  • University of Miami
  • Emory University
  • Indiana University
  • Wayne State University
  • University of New Mexico
  • Cincinnati Children's Medical Center
  • Case Western Reserve University, Rainbow Babies and Children's Hospital
  • University of Tennessee
  • University of Texas Southwestern Medical Center at Dallas
  • University of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surfactant 1

Surfactant 2

Arm Description

Exosurf Neonatal (Burroughs Wellcome Co.)

Survanta (Ross Laboratories)

Outcomes

Primary Outcome Measures

Death or bronchopulmonary dysplasia

Secondary Outcome Measures

Average fraction of inspired oxygen (FIO2)
Mean airway pressure (MAP)

Full Information

First Posted
September 15, 2010
Last Updated
March 20, 2019
Sponsor
NICHD Neonatal Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT01203358
Brief Title
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
Acronym
Surfactant 1
Official Title
Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 1991 (undefined)
Primary Completion Date
January 1992 (Actual)
Study Completion Date
January 1992 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
NICHD Neonatal Research Network

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Respiratory distress syndrome, Surfactant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
617 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surfactant 1
Arm Type
Active Comparator
Arm Description
Exosurf Neonatal (Burroughs Wellcome Co.)
Arm Title
Surfactant 2
Arm Type
Active Comparator
Arm Description
Survanta (Ross Laboratories)
Intervention Type
Drug
Intervention Name(s)
Exosurf
Other Intervention Name(s)
Exosurf Neonatal (Burroughs Wellcome Co.)
Intervention Description
Infants received up to four intratracheal doses of the surfactant.
Intervention Type
Drug
Intervention Name(s)
Survanta
Other Intervention Name(s)
Survanta (Ross Laboratories)
Intervention Description
Infants received up to four intratracheal doses of the surfactant.
Primary Outcome Measure Information:
Title
Death or bronchopulmonary dysplasia
Time Frame
28 days of life
Secondary Outcome Measure Information:
Title
Average fraction of inspired oxygen (FIO2)
Time Frame
72 hours after treatment
Title
Mean airway pressure (MAP)
Time Frame
72 hours after treatment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey D. Horbar, MD
Organizational Affiliation
University of Vermont
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elizabeth C. Wright, PhD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Avroy A. Fanaroff, MD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheldon B. Korones, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seetha Shankaran, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles R. Bauer, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jon E. Tyson, MD MPH
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James A. Lemons, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward F. Donovan, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara J. Stoll, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David K. Stevenson, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LuAnn Papile, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Cincinnati Children's Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University, Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8229487
Citation
Horbar JD, Wright LL, Soll RF, Wright EC, Fanaroff AA, Korones SB, Shankaran S, Oh W, Fletcher BD, Bauer CR, et al. A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1993 Nov;123(5):757-66. doi: 10.1016/s0022-3476(05)80856-x.
Results Reference
result
Links:
URL
http://neonatal.rti.org/
Description
NICHD Neonatal Research Network

Learn more about this trial

Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

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