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The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study

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ClinicalTrials.gov Identifier: NCT00739115
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : August 26, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the safety and utility of using heliox gas in combination with nasal CPAP in premature infants. The investigators hypothesize that using heliox gas in combination with nasal CPAP will results in decreased early nasal CPAP failure requiring intubation and mechanical ventilation.

Condition or disease Intervention/treatment
Respiratory Distress Syndrome, Newborn Other: Heliox gas

Detailed Description:

Introduction: In recent years there has been an increased use of nasal continuous positive airway pressure (nCPAP) in the management of premature infants with respiratory distress syndrome (RDS). The use of early nCPAP eliminates the need for endotracheal intubation and mechanical ventilation, and their associated morbidities. In clinical practice a significant number of extremely low birth weight (ELBW) infants with RDS fail nCPAP therapy within the first 72 hours of life and require rescue endotracheal intubation. The clinical factors resulting in nCPAP failure are hypoxemia, hypoventilation, muscular fatigue and/or apnea. Helium is a biologically inert gas that is used in medicine as a carrier for oxygen. Heliox (mixture of helium and oxygen) has been used safely in neonates for decades and its use has been consistently been shown to improve oxygenation, enhance ventilation and decrease the work of breathing. Prior studies using heliox in the management of premature infants with RDS have shown clear therapeutic benefits. The use of heliox delivered via a nCPAP device (Hx-nCPAP) has recently been reported in infants with bronchiolitis. Given the prior success of heliox in the management of RDS combined with the recent advent of Hx-nCPAP we intend to investigate the utility of Hx-nCPAP in reducing the incidence of early nCPAP failure in ELBW infants with RDS.

Research design: Prospective, open-label, randomized, pilot study comparing conventional nCPAP to Hx-nCPAP in the management of ELBW infants being treated with nCPAP for RDS.

Methods: All spontaneously breathing infants born at < 30 wks estimated gestational age (EGA) admitted to the NICU at KMCWC with the diagnosis of RDS and on nCPAP since birth will be eligible for enrollment. Volunteer Infants will be randomly assigned to conventional nCPAP or Hx-nCPAP groups. Hx-nCPAP will be provided to the study group infants for the first 72 hours of life. Primary and secondary outcome measures will be compared between the heliox group and control group to determine if Hx-nCPAP results in a decreased incidence of early nCPAP failure and/or improved clinical outcomes when compared to conventional nCPAP.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study
Study Start Date : September 2008
Primary Completion Date : August 2011
Study Completion Date : August 2011

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Heliox gas added to nasal CPAP for the first 72 hours of life
Other: Heliox gas
Heliox gas used in conjunction with nasal CPAP
No Intervention: 2
Conventional nasal CPAP for the first 72 hours of life

Outcome Measures

Primary Outcome Measures :
  1. Nasal CPAP failure resulting in endotracheal intubation [ Time Frame: 72 hours of life ]

Secondary Outcome Measures :
  1. Bronchopulmonary dysplasia [ Time Frame: 36 weeks corrected gestational age ]
  2. Hospital length of stay [ Time Frame: At hospital discharge ]
  3. Death [ Time Frame: Prior to hospital discharge ]
  4. Pulmonary interstitial emphysema [ Time Frame: 72 hours of life ]
  5. Pneumothorax [ Time Frame: 72 hours of life ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Gestational age < 33 weeks
  • Receiving CPAP from the time of delivery

Exclusion Criteria:

  • Cyanotic congenital heart disease
  • Congenital malformation
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): NCT00739115

United States, Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Sponsors and Collaborators
Hawaii Pacific Health
Hawaii Community Foundation
Hawaii Medical Service Association (HMSA)
Study Director: Taylor Sawyer, DO Kapiolani Medical Center For Women & Children
More Information

Responsible Party: Charles R. Neal,, Professor, Hawaii Pacific Health
ClinicalTrials.gov Identifier: NCT00739115     History of Changes
Other Study ID Numbers: 07-026-1-HPH1
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by Charles R. Neal,, Hawaii Pacific Health:

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases