Status:
COMPLETED
Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Respiratory Insufficiency of Prematurity
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE3
Brief 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 long...
Detailed Description
The immature lung of extremely low birth weight (ELBW, \< 1000 g) infants is easily damaged by the placement of an endotracheal tube to deliver mechanical ventilation and oxygen. This and the total ti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
1011 Patients enrolled
Trial Details
Trial ID
NCT00433212
Start Date
April 1 2007
End Date
December 1 2011
Last Update
December 5 2014
Active Locations (35)
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1
Georgetown University Children's Medical Center
Washington D.C., District of Columbia, United States, 20007
2
The George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037
3
Tufts University Medical Center
Boston, Massachusetts, United States, 02111
4
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02215