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Completed Phase 3 Interventional

Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)

ClinicalTrials.gov ID: NCT00433212

Public ClinicalTrials.gov record NCT00433212. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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?

Study identification

NCT ID
NCT00433212
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
McMaster University
Other
Enrollment
1,011 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
Up to 28 Days
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2007
Primary completion
Jul 31, 2011
Completion
Nov 30, 2011
Last update posted
Dec 4, 2014

2007 – 2011

United States locations

U.S. sites
14
U.S. states
6
U.S. cities
9
Facility City State ZIP Site status
Georgetown University Children's Medical Center Washington D.C. District of Columbia 20007
The George Washington University Hospital Washington D.C. District of Columbia 20037
Tufts University Medical Center Boston Massachusetts 02111
Beth Israel Deaconess Medical Center (BIDMC) Boston Massachusetts 02215
Virtua West Jersey Hospital Voorhees Township New Jersey 08043
SUNY Downstate Medical Center Brooklyn New York 11023
Kings County Hospital Brooklyn New York 11203
New York Hospital Queens Brooklyn New York 11355
Queens Hospital Center Jamaica New York 11432
Brookdale University Hospital & Medical Center New York New York 11212
Stony Brook University Medical Center Stony Brook New York 11794-8111
Pennsylvania Hospital/U. of Pennsylvania Philadelphia Pennsylvania 19035
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
University of Utah Salt Lake City Utah 84158-1289

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00433212, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 4, 2014 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00433212 live on ClinicalTrials.gov.

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