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

February 5, 2013 updated by: University of Utah

Comparison of Humidified High Flow Nasal Cannula to Nasal Continuous Positive Airway Pressure for Non-Invasive Respiratory Support in Neonates

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 secondary lung injury and subsequent development of bronchopulmonary dysplasia (BPD). As reported by Avery et al and Van Marter et al, early application of nasal continuous positive airway pressure (nCPAP) has been shown as an effective non-invasive mode of respiratory support in this population.(1, 2) Additionally, in the premature sheep and baboon models of BPD, the early use of nCPAP is accompanied by significant improvement in subsequent lung development and alveolization.(3) In light of these findings, there has been a concerted effort in most NICU's to avoid prolonged ventilator support through the early application of nCPAP.

Unfortunately, nCPAP systems are not always easily applied or tolerated in the preterm population.

Difficulties with the application of nCPAP include bulky head wraps, positional problems, compression of the nose, marked dilation and tissue breakdown of the nares, and apparent agitation, often leading to the use of potentially neurotoxic medications.(4) Previous studies have suggested that NC flows at 1-2 lpm may also generate a positive pressure in the airway of preterm infants.(5) The use of NC flow to generate positive airway pressure would minimize many of the application issues of nCPAP. However, standard NC systems used in neonates routinely employ gas that is inadequately warmed and humidified, limiting the use of such flows due to increased risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.(4, 6) The development of humidified high flow via nasal cannulas (HHFNC) systems may obviate these problems and provide a safe, effective alternative to nCPAP in the preterm infant. Unfortunately, HHFNC does not allow the measurement of distending pressure without an invasive process such as an esophageal pressure catheter. Two recent reports have suggested that HHFNC does not provide excessive distending pressure.(7, 8) The study by Saslow and colleagues found that work of breathing and lung compliance were improved in preterm infants on HHFNC up to a maximum of 5 lpm compared to nCPAP at 6 cm H2O.(7) In comparison to nCPAP, the maximum positive distending pressure measured was 4.8 cm H2O and was not significantly increased with HHFNC flows up to 5 lpm. Kubicka and colleagues also demonstrated that the maximum distending pressure measured during support with HHFNC up to 8 lpm was < 5 cm H2O.(8)

A recent publication has suggested that HHFNC can safely and effectively be applied in the non-invasive respiratory management of premature infants with respiratory dysfunction.(9) In this retrospective analysis evaluating over 1000 infants, Shoemaker et al reported a significant decrease in ventilator days among the group of infants managed with HHFNC compared to infants previously managed with nCPAP. Additionally, they found no increased adverse effects noted such as air leak, intraventricular hemorrhage, nosocomial infection or BPD. In a smaller prospective study, Campbell et al did not find a benefit from high-flow NC among a group 40 infants < 1250 grams.(10) However, they did not use adequate humidification and the maximum "high-flow" applied was < 2 lpm. The previously noted study by Woodhead et al demonstrated that HHFNC decreased respiratory work effort and was more effective at preventing reintubation than high-flow from a standard, non-heated, non-humidified nasal cannula.(4)

Thus HHFNC, with flow rates as high as 8 lpm, is being used clinically in a large number of NICU's, including all of the units participating in this study, for management of a variety of neonatal respiratory problems. The introduction of HHFNC into clinical practice has not been accompanied by apparent changes in neonatal outcome, but this has not been systematically studied in a randomized, controlled approach.

The purpose of this randomized controlled trial is to evaluate the clinical impact of applying HHFNC to that of nCPAP among a group of infants requiring continuing non-invasive respiratory support in the NICU.

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shijiazhuang 050031, China
        • Hebei Provincial Children's Hospital
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Children's Hospital of Philadelphia
    • Texas
      • Lackland AFB, Texas, United States, 78236-5300
        • Wilford Hall Medical Center
    • Utah
      • Ogden, Utah, United States, 84403
        • McKay-Dee Medical Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Medical Center
      • Salt Lake City, Utah, United States, 84132
        • University Hospital
      • Salt Lake City, Utah, United States, 84157
        • Intermountain Medical Center
      • St. George, Utah, United States, 84770
        • Dixie Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare extubation success rate, defined as % infants remaining extubated for > 72 hrs, among infants managed with HHFNC versus nCPAP
Time Frame: 72 hrs
72 hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare frequency of significant apnea after extubation to HHFNC v CPAP
Time Frame: 7 days
7 days
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 months
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
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Intermountain Health Care, Inc.

Investigators

  • Principal Investigator: Bradley A Yoder, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24721
  • UofU_IRB_00024721

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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