Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)

Completed · Phase 3

Conditions studied: Respiratory Insufficiency of Prematurity

In brief

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?

Key facts

Study ID

NCT00433212

Run by

McMaster University

People needed

1011

Starts

2007-04-01

Expected to finish

2011-12-01

Last updated by the study team

2014-12-05

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Birth weight <1000 gm
• Gestational age <30 completed weeks
• Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:
• the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support;
• the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.

You may not qualify if…

• Considered non-viable by clinician (decision not to administer effective therapies)
• Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
• Infants known to require surgical treatment
• Abnormalities of the upper and lower airways
• Neuromuscular disorders
• Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube

Where it is running

• Georgetown University Children's Medical Center — Washington D.C., District of Columbia, United States
• The George Washington University Hospital — Washington D.C., District of Columbia, United States
• Tufts University Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States
• Virtua West Jersey Hospital — Voorhees Township, New Jersey, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• Kings County Hospital — Brooklyn, New York, United States
• New York Hospital Queens — Brooklyn, New York, United States
• Queens Hospital Center — Jamaica, New York, United States
• Brookdale University Hospital & Medical Center — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Pennsylvania Hospital/U. of Pennsylvania — Philadelphia, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Utah — Salt Lake City, Utah, United States
• LKH Feldkirch — Feldkirch, Austria
• CHC St. Vincent — Rocourt, Belgium
• St. Boniface General Hospital/University of Manitoba — Winnipeg, Manitoba, Canada
• Winnipeg Health Sciences Centre — Winnipeg, Manitoba, Canada
• IWK Health Centre — Halifax, Nova Scotia, Canada
• McMaster University — Hamilton, Ontario, Canada
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada
• The Ottawa Hospital General Campus — Ottawa, Ontario, Canada
• Hospital for Sick Children — Toronto, Ontario, Canada
• Royal University Hospital — Saskatoon, Saskatchewan, Canada
• Cork University Maternity Hospital — Wilton, Cork, Ireland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.