Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)

Summary

The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.

The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?

Conditions

• Respiratory Insufficiency of Prematurity

Interventions

DEVICE

nCPAP

Deliver non-invasive respiratory support via ventilator with nCPAP device

DEVICE

NIPPV

Deliver non-invasive respiratory support via ventilator with NIPPV device

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• McMaster University

  lead OTHER

Principal Investigators

• Haresh Kirpalani, MD, MSc · Hamilton Health Sciences Corporation

• Brigitte Lemyre, MD · Children's Hospital of Eastern Ontario

• Aaron Chiu, MD · St. Boniface Hospital

• David Millar, MD · Royal Maternity Hospital, Belfast

• Robin S Roberts, MTech · Hamilton Health Sciences/McMaster University

• Bradley Yoder, MD · University of Utah

• Peter H Dijk, MD, PhD · University Medical Centrum Groningen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

28 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2011-08-31

Completion

2011-12-31

Countries

• United States
• Austria
• Belgium
• Canada
• Ireland
• Netherlands
• Qatar
• Singapore
• Sweden
• United Kingdom

Study Locations