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

Primary Purpose

Infant, Newborn, Respiratory Distress Syndrome, Respiratory Insufficiency

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Early surfactant
Standard practice
Sponsored by
NICHD Neonatal Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Newborn focused on measuring NICHD Neonatal Research Network, Pulmonary ventilation, Respiratory distress syndrome, Respiratory insufficiency, Surfactant, pulmonary, Mechanical Ventilation, Survanta

Eligibility Criteria

undefined - 12 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Stanford University
  • Yale University
  • University of Miami
  • Emory University
  • Indiana University
  • Wayne State University
  • University of New Mexico
  • Cincinnati Children's Medical Center
  • Case Western Reserve University, Rainbow Babies and Children's Hospital
  • Brown University, Women & Infants Hospital of Rhode Island
  • University of Tennessee
  • University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early surfactant group

Standard Practice group

Arm Description

Outcomes

Primary Outcome Measures

Need for mechanical ventilation following randomization

Secondary Outcome Measures

Mean duration of mechanical ventilation
Risk morbidities associated with mechanical ventilation and/or early surfactant administration

Full Information

First Posted
June 1, 2000
Last Updated
June 3, 2015
Sponsor
NICHD Neonatal Research Network
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00005774
Brief Title
Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
Acronym
Surfactant 2
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
The trial was stopped after 7 months for lack of recruitment.
Study Start Date
May 2000 (undefined)
Primary Completion Date
July 2002 (Actual)
Study Completion Date
July 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
NICHD Neonatal Research Network
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Respiratory Distress Syndrome, Respiratory Insufficiency
Keywords
NICHD Neonatal Research Network, Pulmonary ventilation, Respiratory distress syndrome, Respiratory insufficiency, Surfactant, pulmonary, Mechanical Ventilation, Survanta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early surfactant group
Arm Type
Experimental
Arm Title
Standard Practice group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Early surfactant
Other Intervention Name(s)
Survanta
Intervention Description
Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)
Intervention Type
Drug
Intervention Name(s)
Standard practice
Intervention Description
Surfactant according to current center practice, only after initiation of mechanical ventilation.
Primary Outcome Measure Information:
Title
Need for mechanical ventilation following randomization
Time Frame
Until hospital discharge or 120 days of life
Secondary Outcome Measure Information:
Title
Mean duration of mechanical ventilation
Time Frame
Until hospital discharge or 120 days of life
Title
Risk morbidities associated with mechanical ventilation and/or early surfactant administration
Time Frame
Until hospital discharge or 120 days of life

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward F. Donovan, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David K. Stevenson, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waldemar A. Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard A. Ehrenkranz, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara J. Stoll, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James A. Lemons, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles R. Bauer, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lu-Ann Papile, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seetha Shankaran, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Avroy A. Fanaroff, MD
Organizational Affiliation
Case Western Reserve University, Rainbow Babies and Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Oh, MD
Organizational Affiliation
Brown University, Women & Infants Hospital of Rhode Island
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheldon B. Korones, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jon E. Tyson, MD MPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Cincinnati Children's Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University, Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Brown University, Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
University of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://neonatal.rti.org/
Description
NICHD Neonatal Research Network

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

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