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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Hawaii Pacific Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hawaii Community Foundation
Hawaii Medical Service Association (HMSA)
Information provided by:
Hawaii Pacific Health
ClinicalTrials.gov Identifier:
NCT00739115
First received: August 20, 2008
Last updated: August 5, 2011
Last verified: February 2009

August 20, 2008
August 5, 2011
September 2008
September 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.

Not Provided
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.
 
Recruiting
20
Not Provided
September 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
No
Contact: Taylor Sawyer, DO 808-551-9074 taylorleesawyer@hotmail.com
Contact: Charles Neal, MD, PhD 808-983-8670 cneal@kapiolani.org
United States
 
NCT00739115
07-026-1-HPH1
Yes
Charles Neal MD, PhD, Kapiolani Medical Center for Women and Children
Hawaii Pacific Health
  • Hawaii Community Foundation
  • Hawaii Medical Service Association (HMSA)
Study Director: Taylor Sawyer, DO Kapiolani Medical Center for Women and Children
Hawaii Pacific Health
February 2009

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