The Use of Heliox to Prevent Early Nasal CPAP Failure in Extremely Low Birth Weight Infants

This study is not yet open for participant recruitment.

Verified by Hawaii Pacific Health, August 2008

Sponsors and Collaborators:	Hawaii Pacific Health Hawaii Community Foundation Hawaii Medical Service Association (HMSA)
Information provided by:	Hawaii Pacific Health
ClinicalTrials.gov Identifier:	NCT00739115

Purpose

The purpose of this study is to evaluate the utility of using heliox gas in combination with nasal CPAP in extremely low birth weight 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 Low Birth Weight	Other: Heliox gas

MedlinePlus related topics: Gas

Drug Information available for: Heliox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Use of Heliox to Prevent Early Nasal CPAP Failure in Extremely Low Birth Weight Infants: A Pilot Study

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:	40
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Heliox gas added to nasal CPAP for the first 72 hours of life	Other: Heliox gas Heliox gas used in conjunction with nasal CPAP
2: No Intervention 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 ≤ 28 weeks
Birth weight ≤ 1000 gms
Receiving CPAP from the time of delivery

Exclusion Criteria:

Cyanotic congenital heart disease
Congenital malformation

Contacts and Locations

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
Honolulu, Hawaii, United States, 96826

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 and Children

More Information

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

Keywords provided by Hawaii Pacific Health:

Respiratory
Distress
Syndrome
Extremely
Low

Birth
Weight
Heliox
CPAP

Study placed in the following topic categories:

Body Weight
Birth Weight
Signs and Symptoms
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009