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

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ClinicalTrials.gov Identifier: NCT00609882
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : February 6, 2013
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment
Respiratory Insufficiency Other: Nasal CPAP Other: Humidified High Flow Nasal Cannula (HHFNC)

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2007
Primary Completion Date : March 2012
Study Completion Date : June 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Compare extubation success rate, defined as % infants remaining extubated for > 72 hrs, among infants managed with HHFNC versus nCPAP [ Time Frame: 72 hrs ]

Secondary Outcome Measures :
  1. Compare frequency of significant apnea after extubation to HHFNC v CPAP [ Time Frame: 7 days ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
University Hospital
Salt Lake City, Utah, United States, 84132
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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases