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Will CPAP Reduce Length Of Respiratory Support In Premature Infants?

NCT00486395 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2012-02-10

No results posted yet for this study

Summary

In Canada each year, there are approximately 800 infants born between 28 and 32 weeks gestation. Up to 60% of these infants will require breathing tube placement for Respiratory Distress Syndrome or RDS. RDS is a lung disease of prematurity due to a lack of a compound called surfactant. The breathing tube is placed as a conduit for placing surfactant into the babies' lungs to improve the lung disease. Most babies are then placed on a breathing machine or ventilator. Ventilation is not without harm and can be associated with lung damage, delays in feeding, increased hospital stay and interruption of bonding. An alternative that does not require the presence of a breathing tube is Continuous Positive Airway Pressure (CPAP). We will randomize babies to either ventilation or CPAP to try to minimize the length of time the baby is kept on respiratory support.

Conditions

  • Prematurity
  • Respiratory Distress Syndrome, Newborn

Interventions

DEVICE

CPAP

CPAP administered via "Bubble" method or Infant Flow Driver

DEVICE

Mechanical ventilation

Volume guarantee strategy

Sponsors & Collaborators

  • Child and Family Research Institute

    collaborator OTHER

  • Children's & Women's Health Centre of British Columbia

    lead OTHER

Principal Investigators

  • Rebecca L Sherlock, MD, FRCPC, PhD(c) · Children's and Women's Health Centre of BC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-01-31
Completion
2011-02-28

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 NCT00486395 on ClinicalTrials.gov