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

NCT00244101 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 648

Last updated 2023-01-18

Study results available
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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.

Conditions

  • Respiratory Distress Syndrome, Newborn

Interventions

DRUG

PS Group

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

DEVICE

NCPAP Group

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

DRUG

ISX Group

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

Sponsors & Collaborators

  • Vermont Oxford Network

    lead NETWORK

Principal Investigators

  • Roger F Soll, MD · Vermont Oxford Network

  • Michael Dunn, MD · Sunnybrook and Women's Hospital, Toronto, Ontario, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
26 Weeks
Max Age
29 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2009-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00244101 on ClinicalTrials.gov