Comparison of Humidified High Flow Nasal Cannula to Nasal CPAP in Neonates

Completed · Not applicable

Conditions studied: Respiratory Insufficiency

In brief

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 of 72 hours, will be equivalent among infants managed with nasal CPAP compared to humidified high flow nasal cannula (HHFNC).

Key facts

Study ID

NCT00609882

Run by

University of Utah

People needed

420

Starts

2007-12-01

Expected to finish

2012-06-01

Last updated by the study team

2013-02-06

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Wilford Hall Medical Center — Lackland Air Force Base, Texas, United States
• McKay-Dee Medical Center — Ogden, Utah, United States
• Utah Valley Regional Medical Center — Provo, Utah, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• University Hospital — Salt Lake City, Utah, United States
• Intermountain Medical Center — Salt Lake City, Utah, United States
• Dixie Medical Center — St. George, Utah, United States
• Hebei Provincial Children's Hospital — Shijiazhuang, China

Full record on ClinicalTrials.gov

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