We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00739115
First Posted: August 21, 2008
Last Update Posted: August 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hawaii Community Foundation
Hawaii Medical Service Association (HMSA)
Information provided by (Responsible Party):
Charles R. Neal,, Hawaii Pacific Health
  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
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

Resource links provided by NLM:


Further study details as provided by Charles R. Neal,, Hawaii Pacific Health:

Primary Outcome Measures:
  • Nasal CPAP failure resulting in endotracheal intubation [ Time Frame: 72 hours of life ]

Secondary Outcome Measures:
  • Bronchopulmonary dysplasia [ Time Frame: 36 weeks corrected gestational age ]
  • Hospital length of stay [ Time Frame: At hospital discharge ]
  • Death [ Time Frame: Prior to hospital discharge ]
  • Pulmonary interstitial emphysema [ Time Frame: 72 hours of life ]
  • Pneumothorax [ Time Frame: 72 hours of life ]

Enrollment: 13
Study Start Date: September 2008
Study Completion Date: August 2011
Primary Completion Date: August 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

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739115


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 & Children
  More Information

Responsible Party: Charles R. Neal,, Professor, Hawaii Pacific Health
ClinicalTrials.gov Identifier: NCT00739115     History of Changes
Other Study ID Numbers: 07-026-1-HPH1
First Submitted: August 20, 2008
First Posted: August 21, 2008
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by Charles R. Neal,, Hawaii Pacific Health:
Respiratory
Distress
Prematurity
Heliox
CPAP

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


To Top