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
  Purpose

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 Intervention
Respiratory Distress Syndrome, Newborn
Other: Heliox gas

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hawaii Pacific Health:

Primary Outcome Measures:
  • Nasal CPAP failure resulting in endotracheal intubation [ Time Frame: 72 hours of life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: September 2008
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 12 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Cyanotic congenital heart disease
  • Congenital malformation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739115

Contacts
Contact: Taylor Sawyer, DO 808-551-9074 taylorleesawyer@hotmail.com
Contact: Charles Neal, MD, PhD 808-983-8670 cneal@kapiolani.org

Locations
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Principal Investigator: Charles Neal, MD, PhD         
Sub-Investigator: Taylor Sawyer, DO         
Sub-Investigator: Timothy Vedder, MD         
Sub-Investigator: Venkataraman Balaraman, MBBS         
Sub-Investigator: David Easa, MD         
Sponsors and Collaborators
Hawaii Pacific Health
Hawaii Community Foundation
Hawaii Medical Service Association (HMSA)
Investigators
Study Director: Taylor Sawyer, DO Kapiolani Medical Center For Women & Children
  More Information

No publications provided

Responsible Party: Charles Neal MD, PhD, Kapiolani Medical Center for Women and Children
ClinicalTrials.gov Identifier: NCT00739115     History of Changes
Other Study ID Numbers: 07-026-1-HPH1
Study First Received: August 20, 2008
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Hawaii Pacific Health:
Respiratory
Distress
Prematurity
Heliox
CPAP

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

ClinicalTrials.gov processed this record on September 16, 2014