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Non-invasive Respiratory Support in Preterm Infants

NCT03512158 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-12-16

No results posted yet for this study

Summary

Lungs of babies born early are not fully developed and they often need a machine to help them breathe. The traditional approach to provide this support is with a breathing tube passed into the windpipe. However, we know that breathing tubes can cause injury to the fragile lungs of premature babies. Providing breathing support through nose-masks instead of breathing tubes (called nasal breathing support) is becoming popular, as it is gentler on developing lungs. Doctors, in trying to limit the use of support with a breathing tube, are using many different forms of nasal breathing support. The most common form is nasal continuous positive airway pressure (CPAP) which delivers a constant pressure and the baby breathes on his on her own. However, when this strategy is no longer able to support a premature baby's breathing, the best way to provide breathing support is not known. Some doctors use a strategy called "nasal intermittent positive airway pressure" (NIPPV) which gives the baby artificial breaths through the nose-mask. Others simply increase the pressure on nasal CPAP to higher than traditional levels. In the first study of its kind, we will compare these two strategies of nasal breathing support given to premature babies.

Conditions

  • Preterm Infant
  • Respiratory Insufficiency Syndrome of Newborn
  • Bronchopulmonary Dysplasia

Interventions

OTHER

Non-invasive respiratory support mode

A mode of providing respiratory support via nasal masks or prongs

Sponsors & Collaborators

  • Hamilton Academic Health Sciences Organization

    collaborator OTHER

  • Hamilton Health Sciences Foundation - New Investigator Fund

    collaborator UNKNOWN

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • McMaster Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2023-11-30
Completion
2023-12-31

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 NCT03512158 on ClinicalTrials.gov