Status:
COMPLETED
Comparison of Humidified High Flow Nasal Cannula to Nasal CPAP in Neonates
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Intermountain Health Care, Inc.
Conditions:
Respiratory Insufficiency
Eligibility:
All Genders
Up to 8 years
Phase:
NA
Brief Summary
We hypothesize that the success rate for keeping babies extubated (without a breathing tube for assisted mechanical ventilation), defined as the proportion of infants remaining extubated for a minimum...
Detailed Description
Respiratory failure remains a common problem in the neonatal ICU. Among premature infants with respiratory failure the use of mechanical ventilation has been associated with increased risk for seconda...
Eligibility Criteria
Inclusion
- Birth weight \> 1000 grams and \> 27 weeks gestation
- Candidate for non-invasive respiratory support as a result of:
- an intention to manage the infant with non-invasive (no endotracheal tube) respiratory support from birth initiated in the first 24 hours of life
- an intention to extubate an infant being managed with intubated respiratory support to non-invasive support
Exclusion
- Birth weight \< 1000 grams
- Estimated gestation \< 29 weeks
- Participation in a concurrent study that prohibits the use of HHFNC
- Active air leak syndrome
- Infants with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis, cleft lip and/or palate, or
- Infants with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00609882
Start Date
December 1 2007
End Date
June 1 2012
Last Update
February 6 2013
Active Locations (9)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
2
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236-5300
3
McKay-Dee Medical Center
Ogden, Utah, United States, 84403
4
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604