NCT01203358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
617

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 1991

Shorter than P25 for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1991

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1992

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1992

Completed
18.7 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

September 15, 2010

Last Update Submit

March 20, 2019

Conditions

Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, PrematureBronchopulmonary Dysplasia

Keywords

NICHD Neonatal Research NetworkExtremely Low Birth Weight (ELBW)PrematurityRespiratory distress syndromeSurfactant

Outcome Measures

Primary Outcomes (1)

  • Death or bronchopulmonary dysplasia

    28 days of life

Secondary Outcomes (2)

  • Average fraction of inspired oxygen (FIO2)

    72 hours after treatment

  • Mean airway pressure (MAP)

    72 hours after treatment

Study Arms (2)

Surfactant 1

ACTIVE COMPARATOR

Exosurf Neonatal (Burroughs Wellcome Co.)

Drug: Exosurf

Surfactant 2

ACTIVE COMPARATOR

Survanta (Ross Laboratories)

Drug: Survanta

Interventions

ExosurfDRUG

Infants received up to four intratracheal doses of the surfactant.

Also known as: Exosurf Neonatal (Burroughs Wellcome Co.)
Surfactant 1
SurvantaDRUG

Infants received up to four intratracheal doses of the surfactant.

Also known as: Survanta (Ross Laboratories)
Surfactant 2

Eligibility Criteria

AgeUp to 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Less than 6 hours of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Stanford University

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

  • 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.

    PMID: 8229487RESULT

Related Links

MeSH Terms

Conditions

Premature BirthBronchopulmonary DysplasiaRespiratory Distress Syndrome

Interventions

dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combinationberactant

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVentilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiration Disorders

Study Officials

  • Jeffrey D. Horbar, MD

    University of Vermont

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

January 1, 1991

Primary Completion

January 1, 1992

Study Completion

January 1, 1992

Last Updated

March 22, 2019

Record last verified: 2019-03

Locations

US(13)