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Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants (Surfactant 2)

This study has been terminated.
(The trial was stopped after 7 months for lack of recruitment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005774
First Posted: June 2, 2000
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network
  Purpose
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.

Condition Intervention Phase
Infant, Newborn Respiratory Distress Syndrome Respiratory Insufficiency Drug: Early surfactant Drug: Standard practice Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250- 2000 Grams With RDS

Resource links provided by NLM:


Further study details as provided by NICHD Neonatal Research Network:

Primary Outcome Measures:
  • Need for mechanical ventilation following randomization [ Time Frame: Until hospital discharge or 120 days of life ]

Secondary Outcome Measures:
  • Mean duration of mechanical ventilation [ Time Frame: Until hospital discharge or 120 days of life ]
  • Risk morbidities associated with mechanical ventilation and/or early surfactant administration [ Time Frame: Until hospital discharge or 120 days of life ]

Enrollment: 61
Study Start Date: May 2000
Study Completion Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early surfactant group Drug: Early surfactant
Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)
Other Name: Survanta
Active Comparator: Standard Practice group Drug: Standard practice
Surfactant according to current center practice, only after initiation of mechanical ventilation.

Detailed Description:

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. The role of surfactant therapy in the management of larger infants with respiratory distress syndrome (RDS) was unclear. In many neonatal intensive care units, these infants were routinely managed with continuous positive airway pressure (CPAP) alone.

This trial tested whether early use of surfactant combined with CPAP would ameliorate the course of RDS without an increased risk of death. Primary study outcomes were measures of use of mechanical ventilation, and thereby likely reduction in risk of ventilator-associated morbidity.

Eligible infants were randomized before the infant is 12 hours of age to receive either: early surfactant followed by extubation within 30 minutes and application of CPAP (intervention group); or surfactant according to current center practice, only after initiation of mechanical ventilation (control group).

The trial was stopped after 7 months for lack of recruitment.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Receiving mechanical ventilation
  • Air leak
  • Pulmonary hemorrhage
  • Major congenital anomaly
  • Congenital non-bacterial infection
  • Parental refusal of consent
  • Refusal of attending neonatologist
  Contacts and Locations
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): NCT00005774


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
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, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Investigators
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
  More Information

Additional Information:
Responsible Party: Edward F. Donovan, Lead Principal Investigator, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT00005774     History of Changes
Other Study ID Numbers: NICHD-NRN-0024
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD034167 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD021415 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD027881 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U01HD036790 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
M01RR006022 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
M01RR000997 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
M01RR001032 ( U.S. NIH Grant/Contract )
First Submitted: June 1, 2000
First Posted: June 2, 2000
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Pulmonary ventilation
Respiratory distress syndrome
Respiratory insufficiency
Surfactant, pulmonary
Mechanical Ventilation
Survanta

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Pulmonary Surfactants
Beractant
Respiratory System Agents