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Pilot Study Comparing Different Modes of Non-invasive Ventilation for the Oral Feeding of Preterm Infants

NCT02055339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-11-09

No results posted yet for this study

Summary

Preterm infants born before 28 weeks gestation are at risk for lung disease and require oxygen and pressure to keep their lungs open. This usually involves a device called nasal continuous positive airway pressure (nCPAP). When preterm babies reach a certain age, they are ready to begin to feed by mouth, but for those on nCPAP, oral feeds are usually not started due to concerns for choking. This may cause them to miss their window of learning and may lead to a longer hospital stay or oral aversion. Sometimes babies are switched from nCPAP to low flow oxygen (LFO2) for a short time for oral feeds, but this may not provide enough support for their lungs. Heated, humidified high flow nasal cannula (HHHFNC) is another mode of providing oxygen and pressure. It is equal to nCPAP in small babies transitioning off of ventilators, but no studies have been done in older babies. We plan to compare the feeding of babies orally using either nCPAP with LFO2 or HHHFNC in preterm babies born before 28 weeks gestation who are now 34 weeks corrected gestational age. The goal will be the fastest time to full oral feeds.

Conditions

Interventions

DEVICE

Fisher & Paykel heated humidified high flow nasal cannula

DEVICE

InfantFlow/RAM nasal continuous positive airway pressure

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Sandra Leibel, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02055339 on ClinicalTrials.gov