The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

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.
    

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.
    

Intervention name(s): Heliox gas
Intervention type(s): Other
Intervention description(s): Heliox gas used in conjunction with nasal CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Respiratory; Distress; Prematurity; Heliox; CPAP