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Very Early Surfactant and NCPAP for Premature Infants With RDS

NCT00563641 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2007-11-26

No results posted yet for this study

Summary

The present study will test the use of very early nasal continuous airway pressure(NCPAP)with and without surfactant in premature infants with clinical evidence or respiratory distress syndrome. We hypothesize that premature infants exposed to very early NCPAP and surfactant will require less mechanical ventilation compared to those premature infants exposed to NCPAP alone.

Conditions

Interventions

OTHER

Very early surfactant and bubble NCPAP

For patients randomized to early NCPAP plus surfactant, 4ml/kg of surfactant were administered through an endotracheal tube in two aliquots, 2 minutes apart followed by positive pressure ventilation administered for one minute with a Neopuff Infant Resuscitator pre-set to give a peak pressure of 20 cm H2O and 5 cm H2O of positive end expiratory pressure. Infant was then extubated and placed on NCPAP of 6 cmH2O

OTHER

bubble NCPAP

Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach "yes or no" treatment failure criteria.

Sponsors & Collaborators

  • Pontificia Universidad Javeriana

    collaborator OTHER

  • Vanderbilt University School of Medicine

    collaborator OTHER

  • Abbott

    collaborator INDUSTRY

  • Fisher and Paykel Healthcare

    collaborator INDUSTRY

  • Colombian Neonatal Research Network

    lead OTHER

Principal Investigators

  • Mario A Rojas, MD, MPH · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
27 Weeks
Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2006-12-31

Countries

  • Colombia

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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 NCT00563641 on ClinicalTrials.gov