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E-23596 - Use of NCPAP Cycling to Wean Preterm Infants

NCT02114112 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-04-15

No results posted yet for this study

Summary

Objective: To compare the effectiveness of nasal continuous positive airway pressure (NCPAP) cycling to continuous NCPAP in successful weaning of preterm infants of 25-28 weeks gestation to nasal prongs.

Methods: A total of 40 infants with a gestational age (GA) of 25-28 weeks ventilated for respiratory distress syndrome (RDS) and extubated to NCPAP are eligible for the study. They will be randomized to NCPAP cycling {Group A; cycling between NCPAP of 4 cm and 1litre per minute of nasal prongs} or to continuous CPAP at 4 cm of water (Group B). Primary outcome is the number of babies who came off NCPAP at the end of 72 hours of the intervention and remained off NCPAP for the next 72 hours. The duration of NCPAP, Bronchopulmonary dysplasia (BPD) at 36 weeks post menstrual age and Retinopathy of Prematurity (ROP) stage ≥3 will be the secondary outcomes.

Conditions

  • Premature Birth

Interventions

OTHER

NCPAP cycling

OTHER

NCPAP continuous

Sponsors & Collaborators

  • Alberta Children's Hospital

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Abhay Lodha, MD, DM,MSc · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
72 Hours
Max Age
75 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-11-30
Completion
2014-03-31

Countries

  • Canada

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 NCT02114112 on ClinicalTrials.gov