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

This study has been completed.
Sponsor:
Collaborators:
Hawaii Community Foundation
Hawaii Medical Service Association (HMSA)
Information provided by (Responsible Party):
Charles R. Neal,, Hawaii Pacific Health
ClinicalTrials.gov Identifier:
NCT00739115
First received: August 20, 2008
Last updated: August 25, 2015
Last verified: August 2015

August 20, 2008
August 25, 2015
September 2008
August 2011   (final data collection date for primary outcome measure)
Nasal CPAP failure resulting in endotracheal intubation [ Time Frame: 72 hours of life ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00739115 on ClinicalTrials.gov Archive Site
  • Bronchopulmonary dysplasia [ Time Frame: 36 weeks corrected gestational age ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: At hospital discharge ] [ Designated as safety issue: No ]
  • Death [ Time Frame: Prior to hospital discharge ] [ Designated as safety issue: Yes ]
  • Pulmonary interstitial emphysema [ Time Frame: 72 hours of life ] [ Designated as safety issue: Yes ]
  • Pneumothorax [ Time Frame: 72 hours of life ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study
The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Respiratory Distress Syndrome, Newborn
Other: Heliox gas
Heliox gas used in conjunction with nasal CPAP
  • Experimental: 1
    Heliox gas added to nasal CPAP for the first 72 hours of life
    Intervention: Other: Heliox gas
  • No Intervention: 2
    Conventional nasal CPAP for the first 72 hours of life
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Cyanotic congenital heart disease
  • Congenital malformation
Both
up to 12 Hours   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00739115
07-026-1-HPH1
Yes
Not Provided
Not Provided
Charles R. Neal,, Hawaii Pacific Health
Hawaii Pacific Health
  • Hawaii Community Foundation
  • Hawaii Medical Service Association (HMSA)
Study Director: Taylor Sawyer, DO Kapiolani Medical Center For Women & Children
Hawaii Pacific Health
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP