Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome (Surfactant 1)
This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01203358
First received: September 15, 2010
Last updated: January 9, 2011
Last verified: September 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Bronchopulmonary Dysplasia |
Drug: Exosurf Drug: Survanta |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Death or bronchopulmonary dysplasia [ Time Frame: 28 days of life ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Average fraction of inspired oxygen (FIO2) [ Time Frame: 72 hours after treatment ] [ Designated as safety issue: Yes ]
- Mean airway pressure (MAP) [ Time Frame: 72 hours after treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 617 |
| Study Start Date: | January 1991 |
| Study Completion Date: | January 1992 |
| Primary Completion Date: | January 1992 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Surfactant 1
Exosurf Neonatal (Burroughs Wellcome Co.)
|
Drug: Exosurf
Infants received up to four intratracheal doses of the surfactant.
Other Name: 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 Name: Survanta (Ross Laboratories)
|
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.
Eligibility| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 | Cincinnati Children's Medical Center |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Jeffrey D. Horbar/ Lead Principal Investigator, University of Vermont |
| ClinicalTrials.gov Identifier: | NCT01203358 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0003, U01HD019897, U10HD021364, U10HD021373, U10HD021385, U10HD021397, U10HD021415, U10HD027856, U10HD027853, U10HD027871, U10HD027851, U10HD027880, U10HD027881 |
| Study First Received: | September 15, 2010 |
| Last Updated: | January 9, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity Respiratory distress syndrome Surfactant |
Additional relevant MeSH terms:
|
Birth Weight Bronchopulmonary Dysplasia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Body Weight Signs and Symptoms Ventilator-Induced Lung Injury Lung Injury Lung Diseases |
Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Respiration Disorders Pulmonary Surfactants Beractant Respiratory System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013