CClinicalTrials.gg
CompletedNCT00739115Updated Aug 26, 2015

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

An interventional study of Heliox gas in Respiratory Distress Syndrome, Newborn, sponsored by Hawaii Pacific Health. Completed at 1 site in United States. Open to participants aged 1 Minute to 12 Hours. Per ClinicalTrials.gov, last updated 2015-08-26.

Sponsored by Hawaii Pacific Health · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
1 Minute to 12 Hours
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Respiratory Distress Syndrome, Newborn

Keywords

  • Respiratory
  • Distress
  • Prematurity
  • Heliox
  • CPAP
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 13 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Hawaii Pacific Health is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 12 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Cyanotic congenital heart disease
  • Congenital malformation
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    1

    Heliox gas added to nasal CPAP for the first 72 hours of life

    Other: Heliox gas

  • No intervention
    2

    Conventional nasal CPAP for the first 72 hours of life

Interventions

  • OtherHeliox gas

    Heliox gas used in conjunction with nasal CPAP

06

What researchers measure

Primary outcomes

  1. Nasal CPAP failure resulting in endotracheal intubation

    Time frame: 72 hours of life

Secondary outcomes

  1. Bronchopulmonary dysplasia

    Time frame: 36 weeks corrected gestational age

  2. Hospital length of stay

    Time frame: At hospital discharge

  3. Death

    Time frame: Prior to hospital discharge

  4. Pulmonary interstitial emphysema

    Time frame: 72 hours of life

  5. Pneumothorax

    Time frame: 72 hours of life

07

Study locations

1 site
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00739115
Lead sponsor
Hawaii Pacific Health
Collaborators
Hawaii Community Foundation, Hawaii Medical Service Association
Responsible party
Charles R. Neal, (Professor, Hawaii Pacific Health) — Principal investigator
First posted
Aug 21, 2008
Start date
Sep 2008
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Aug 26, 2015

Study contacts

Taylor Sawyer, DO
study director · Kapiolani Medical Center For Women & Children

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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