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

Sponsor

Hawaii Pacific Health (Other)

Overall Status

Completed

CT.gov ID

NCT00739115

Collaborator

Hawaii Community Foundation (Other), Hawaii Medical Service Association (Other)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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	Phase
Respiratory Distress Syndrome, Newborn	Other: Heliox gas	N/A

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

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 :

Sep 1, 2008

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 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

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

Nasal CPAP failure resulting in endotracheal intubation [72 hours of life]

Secondary Outcome Measures

Bronchopulmonary dysplasia [36 weeks corrected gestational age]
Hospital length of stay [At hospital discharge]
Death [Prior to hospital discharge]
Pulmonary interstitial emphysema [72 hours of life]
Pneumothorax [72 hours of life]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Minute to 12 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Cyanotic congenital heart disease
Congenital malformation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

Study Director: Taylor Sawyer, DO, Kapiolani Medical Center For Women & Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Charles R. Neal,, Professor, Hawaii Pacific Health

ClinicalTrials.gov Identifier:

NCT00739115

Other Study ID Numbers:

07-026-1-HPH1

First Posted:

Aug 21, 2008

Last Update Posted:

Aug 26, 2015

Last Verified:

Aug 1, 2015

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

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of Aug 26, 2015