Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome (Surfactant 1)
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| ClinicalTrials.gov Identifier: NCT01203358 |
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Recruitment Status :
Completed
First Posted : September 16, 2010
Last Update Posted : March 22, 2019
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Sponsor:
NICHD Neonatal Research Network
Information provided by:
NICHD Neonatal Research Network
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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 |
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 Type : | Interventional (Clinical Trial) |
| 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 : | January 1991 |
| Actual Primary Completion Date : | January 1992 |
| Actual Study Completion Date : | January 1992 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Beractant
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Surfactant 1
Exosurf Neonatal (Burroughs Wellcome Co.)
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Drug: Exosurf
Infants received up to four intratracheal doses of the surfactant.
Other Name: Exosurf Neonatal (Burroughs Wellcome Co.) |
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Active Comparator: Surfactant 2
Survanta (Ross Laboratories)
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Drug: Survanta
Infants received up to four intratracheal doses of the surfactant.
Other Name: Survanta (Ross Laboratories) |
Primary Outcome Measures :
- Death or bronchopulmonary dysplasia [ Time Frame: 28 days of life ]
Secondary Outcome Measures :
- Average fraction of inspired oxygen (FIO2) [ Time Frame: 72 hours after treatment ]
- Mean airway pressure (MAP) [ Time Frame: 72 hours after treatment ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 6 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203358
Locations
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| George Washington University | |
| Washington, District of Columbia, United States, 20052 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| United States, Vermont | |
| 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 |
Additional Information:
Publications of Results:
Publications of Results:
| Responsible Party: | Jeffrey D. Horbar/ Lead Principal Investigator, University of Vermont |
| ClinicalTrials.gov Identifier: | NCT01203358 |
| Other Study ID Numbers: |
NICHD-NRN-0003 U01HD019897 ( U.S. NIH Grant/Contract ) U10HD021364 ( U.S. NIH Grant/Contract ) U10HD021373 ( U.S. NIH Grant/Contract ) U10HD021385 ( U.S. NIH Grant/Contract ) U10HD021397 ( U.S. NIH Grant/Contract ) U10HD021415 ( U.S. NIH Grant/Contract ) U10HD027856 ( U.S. NIH Grant/Contract ) U10HD027853 ( U.S. NIH Grant/Contract ) U10HD027871 ( U.S. NIH Grant/Contract ) U10HD027851 ( U.S. NIH Grant/Contract ) U10HD027880 ( U.S. NIH Grant/Contract ) U10HD027881 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 16, 2010 Key Record Dates |
| Last Update Posted: | March 22, 2019 |
| Last Verified: | March 2019 |
Keywords provided by NICHD Neonatal Research Network:
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NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity Respiratory distress syndrome Surfactant |
Additional relevant MeSH terms:
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Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Bronchopulmonary Dysplasia Birth Weight Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases |
Infant, Newborn, Diseases Body Weight Ventilator-Induced Lung Injury Lung Injury Beractant Pulmonary Surfactants Respiratory System Agents |