Study Stopped
The trial was stopped after 7 months for lack of recruitment.
Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
Surfactant 2
Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250- 2000 Grams With RDS
21 other identifiers
interventional
61
1 country
13
Brief Summary
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2000
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedFirst Submitted
Initial submission to the registry
June 1, 2000
CompletedFirst Posted
Study publicly available on registry
June 2, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2002
CompletedJune 8, 2015
June 1, 2015
2.2 years
June 1, 2000
June 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Need for mechanical ventilation following randomization
Until hospital discharge or 120 days of life
Secondary Outcomes (2)
Mean duration of mechanical ventilation
Until hospital discharge or 120 days of life
Risk morbidities associated with mechanical ventilation and/or early surfactant administration
Until hospital discharge or 120 days of life
Study Arms (2)
Early surfactant group
EXPERIMENTALStandard Practice group
ACTIVE COMPARATORInterventions
Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)
Surfactant according to current center practice, only after initiation of mechanical ventilation.
Eligibility Criteria
You may qualify if:
- Infants born at 1,250-2g000 grams birth weight
- \<12 hours of age
- Clinical and radiographic diagnosis of respiratory distress syndrome (RDS)
- Receiving supplemental oxygen with head-hood Fi02 of 0.35 to 0.50 or CPAP Fi02 of 0.25 to 0.50 to maintain oxygen saturation less than 90 percent and more than 96 percent
You may not qualify if:
- Receiving mechanical ventilation
- Air leak
- Pulmonary hemorrhage
- Major congenital anomaly
- Congenital non-bacterial infection
- Parental refusal of consent
- Refusal of attending neonatologist
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Stanford University
Palo Alto, California, 94304, United States
Yale University
New Haven, Connecticut, 06504, United States
University of Miami
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30303, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Wayne State University
Detroit, Michigan, 48201, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Edward F. Donovan, MD
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
David K. Stevenson, MD
Stanford University
- PRINCIPAL INVESTIGATOR
Waldemar A. Carlo, MD
University of Alabama at Birmingham
- PRINCIPAL INVESTIGATOR
Richard A. Ehrenkranz, MD
Yale University
- PRINCIPAL INVESTIGATOR
Barbara J. Stoll, MD
Emory University
- PRINCIPAL INVESTIGATOR
James A. Lemons, MD
Indiana University
- PRINCIPAL INVESTIGATOR
Charles R. Bauer, MD
University of Miami
- PRINCIPAL INVESTIGATOR
Lu-Ann Papile, MD
University of New Mexico
- PRINCIPAL INVESTIGATOR
Seetha Shankaran, MD
Wayne State University
- PRINCIPAL INVESTIGATOR
Avroy A. Fanaroff, MD
Case Western Reserve University, Rainbow Babies and Children's Hospital
- PRINCIPAL INVESTIGATOR
William Oh, MD
Brown University, Women & Infants Hospital of Rhode Island
- PRINCIPAL INVESTIGATOR
Sheldon B. Korones, MD
University of Tennessee
- PRINCIPAL INVESTIGATOR
Jon E. Tyson, MD MPH
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
June 1, 2000
First Posted
June 2, 2000
Study Start
May 1, 2000
Primary Completion
July 1, 2002
Study Completion
July 1, 2002
Last Updated
June 8, 2015
Record last verified: 2015-06