MedTrace Logo

Effect of Establishing Functional Residual Capacity During Newborn Resuscitation on Oxygenation

NCT00531102 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-10-12

No results posted yet for this study

Summary

Currently, newborns receive 100% supplemental oxygen by free flow when they remain cyanotic despite demonstrating regular respiratory effort. Resuscitating infants with continuous positive airway pressure (CPAP) in room air may improve oxygen saturations more quickly than providing FFO2 because of its ability to establish functional residual capacity in the lungs. Our primary hypothesis is that in this blinded, randomized control trial, more infants (≥35 weeks gestation) resuscitated with CPAP in room air will have an oxygen saturation ≥80% at five minutes of age compared to infants resuscitated with the 50% FFO2.

Conditions

  • Resuscitation

Interventions

OTHER

continuous positive airway pressure

Infants will receive CPAP of 6 cm H2O with 21% oxygen continuously for at least 5 minutes

OTHER

Free flow oxygen

Infants will receive 50% oxygen delivered by a modified neonatal T-piece resuscitator circuit that does not generate pressure for at least 5 minutes.

Sponsors & Collaborators

Principal Investigators

  • Yacov Rabi, MD, FRCPC · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
1 Minute
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT00531102 on ClinicalTrials.gov