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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2002

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.

Interventions

  • Drug: Early surfactant
    • Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)
  • Drug: Standard practice
    • Surfactant according to current center practice, only after initiation of mechanical ventilation.

Arms, Groups and Cohorts

  • Experimental: Early surfactant group
  • Active Comparator: Standard Practice group

Clinical Trial Outcome Measures

Primary Measures

  • Need for mechanical ventilation following randomization
    • Time Frame: Until hospital discharge or 120 days of life

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 12 Hours

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NICHD Neonatal Research Network
  • Collaborator
    • National Center for Research Resources (NCRR)
  • Provider of Information About this Clinical Study
    • Edward F. Donovan, Lead Principal Investigator, Cincinnati Children’s Hospital Medical Center
  • Overall Official(s)
    • Edward F. Donovan, MD, Study Director, Children’s Hospital Medical Center, Cincinnati
    • David K. Stevenson, MD, Principal Investigator, Stanford University
    • Waldemar A. Carlo, MD, Principal Investigator, University of Alabama at Birmingham
    • Richard A. Ehrenkranz, MD, Principal Investigator, Yale University
    • Barbara J. Stoll, MD, Principal Investigator, Emory University
    • James A. Lemons, MD, Principal Investigator, Indiana University
    • Charles R. Bauer, MD, Principal Investigator, University of Miami
    • Lu-Ann Papile, MD, Principal Investigator, University of New Mexico
    • Seetha Shankaran, MD, Principal Investigator, Wayne State University
    • Avroy A. Fanaroff, MD, Principal Investigator, Case Western Reserve University, Rainbow Babies and Children’s Hospital
    • William Oh, MD, Principal Investigator, Brown University, Women & Infants Hospital of Rhode Island
    • Sheldon B. Korones, MD, Principal Investigator, University of Tennessee
    • Jon E. Tyson, MD MPH, Principal Investigator, The University of Texas Health Science Center, Houston

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