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Clinical Trials/NCT00244101
NCT00244101CompletedPhase 3

Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome

Vermont Oxford Network1 site in 1 country648 target enrollmentStarted: August 2003Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
648
Locations
1
Primary Endpoint
Death or Chronic Lung Disease

Study Overview

Brief Summary

The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.

Detailed Description

The "Delivery room management of premature infants at high risk of respiratory distress syndrome" protocol compares three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk of respiratory distress syndrome. The three approaches to post-delivery care include:

  1. Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
  2. Early stabilization on nasal continuous positive airway pressure (NCPAP) with selective intubation and surfactant administration for clinical indications.
  3. Intubation, prophylactic surfactant administration shortly after delivery and rapid extubation to nasal CPAP.

The primary null hypothesis for this study is that no difference will be found in chronic lung disease and/or mortality at 36 weeks adjusted age in premature infants at high risk of RDS, depending on the method of post-delivery stabilization.

The study is a randomized, multicenter trial conducted at participating Vermont Oxford Network Centers. Participating centers will demonstrate competency in the use of nasal CPAP by successfully completing a web-based, educational program and utilizing nasal CPAP in a minimum of 20 infants in their NICU.

Infants likely to be delivered to women presenting to a participating Vermont Oxford Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks will be eligible for inclusion. Specific inclusion criteria that must be met prior to randomization include:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
26 Weeks to 29 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Infants likely to be delivered to women presenting to a participating Vermont Oxford Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks will be eligible for inclusion. Specific inclusion criteria that must be met prior to randomization include:
  • Imminent delivery
  • No potentially life-threatening congenital anomaly or genetic syndrome
  • No known lung maturity
  • Antenatal steroid status known
  • Written, informed consent obtained (on admission or prior to delivery).

Exclusion Criteria

  • Stillborn (Apgar score of 0 at one minute of age)
  • Noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.

Arms & Interventions

PS Group

Active Comparator

Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.

Intervention: PS Group (Drug)

NCPAP Group

Experimental

Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.

Intervention: NCPAP Group (Device)

ISX Group

Experimental

Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.

Intervention: ISX Group (Drug)

Outcomes

Primary Outcomes

Death or Chronic Lung Disease

Time Frame: at 36 weeks postmenstrual age

Death

Time Frame: 36 weeks adjusted age

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (1)

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