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

Conditions:Obesity Weight Loss, Hospital, Women's Studies, Pulmonary
Therapuetic Areas:Endocrinology, Pulmonary / Respiratory Diseases, Other, Reproductive
Age Range:Any
Start Date:September 2008
End Date:August 2011

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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.

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.

Inclusion Criteria:

- Gestational age < 33 weeks

- Receiving CPAP from the time of delivery

Exclusion Criteria:

- Cyanotic congenital heart disease

- Congenital malformation
We found this trial at
1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
Honolulu, HI
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