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Comparison of Humidified High Flow Nasal Cannula to Nasal CPAP in Neonates (HHFNC)

This study has been completed.
Sponsor:
Collaborator:
Intermountain Health Care, Inc.
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00609882
First received: January 24, 2008
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention
Respiratory Insufficiency
 Other: Nasal CPAP
Other: Humidified High Flow Nasal Cannula (HHFNC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Humidified High Flow Nasal Cannula to Nasal Continuous Positive Airway Pressure for Non-Invasive Respiratory Support in Neonates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Compare extubation success rate, defined as % infants remaining extubated for > 72 hrs, among infants managed with HHFNC versus nCPAP [ Time Frame: 72 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare frequency of significant apnea after extubation to HHFNC v CPAP [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Compare total duration of ventilator, positive pressure (CPAP and/or HHFNC), and oxygen use up to the time of discharge from the NICU [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Compare incidence of potential adverse effects associated with the use of nasal CPAP and HHFNC including pulmonary air leaks, nasal deformities, feeding intolerance, necrotizing enterocolitis, intestinal perforation and BPD [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Compare weight gain and the time to establish full enteral feeds (> 120 ml/kg/d) between infants on HHFNC v CPAP [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 420
Study Start Date: December 2007
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HHFNC
Infants randomized to the Humidified High Flow Nasal Cannula (HHFNC) treatment group post extubation
 Other: Nasal CPAP
Infants randomized to the Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O post extubation
Other: Humidified High Flow Nasal Cannula (HHFNC)
HHFNC
Active Comparator: nCPAP
Infants randomized to the nasal Continuous Positive Airway Pressure (nCPAP) treatment group
 Other: Nasal CPAP
Infants randomized to the Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O post extubation
Other: Humidified High Flow Nasal Cannula (HHFNC)
HHFNC

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  Eligibility

Ages Eligible for Study:   up to 8 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Birth weight > 1000 grams and > 27 weeks gestation

  2. Candidate for non-invasive respiratory support as a result of:

    1. an intention to manage the infant with non-invasive (no endotracheal tube) respiratory support from birth initiated in the first 24 hours of life
    2. an intention to extubate an infant being managed with intubated respiratory support to non-invasive support

Exclusion Criteria:

  1. Birth weight < 1000 grams
  2. Estimated gestation < 29 weeks
  3. Participation in a concurrent study that prohibits the use of HHFNC
  4. Active air leak syndrome
  5. 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
  6. Infants with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609882

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
United States, Texas
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236-5300
United States, Utah
McKay-Dee Medical Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604
University Hospital
Salt Lake City, Utah, United States, 84132
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
Intermountain Medical Center
Salt Lake City, Utah, United States, 84157
Dixie Medical Center
St. George, Utah, United States, 84770
China
Hebei Provincial Children's Hospital
Shijiazhuang 050031, China
Sponsors and Collaborators
University of Utah
Intermountain Health Care, Inc.
Investigators
Principal Investigator: Bradley A Yoder, MD University of Utah
  More Information

Publications:

Responsible Party: Bradley A. Yoder, MD, University of Utah School of Medicine
ClinicalTrials.gov Identifier: NCT00609882     History of Changes
Other Study ID Numbers: 24721, UofU_IRB_00024721
Study First Received: January 24, 2008
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Nasal CPAP
High flow nasal cannula
Neonate

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013