Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms

  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn

NCT number NCT00739115
Study type Interventional
Source Hawaii Pacific Health
Contact
Status Completed
Phase N/A
Start date September 2008
Completion date August 2011

See also
  Status Clinical Trial Phase
Recruiting NCT01206946 - Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants Phase 2
Terminated NCT00486395 - Will CPAP Reduce Length Of Respiratory Support In Premature Infants? Phase 3
Completed NCT01242462 - Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial Phase 1/Phase 2
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1
Completed NCT00486850 - Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress Phase 4
Terminated NCT00005776 - Inhaled Nitric Oxide Study for Respiratory Failure in Newborns Phase 3
Completed NCT04500353 - Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial N/A
Completed NCT05796128 - NIPPV vs.nCPAP During LISA Procedure N/A
Withdrawn NCT02835209 - Positioning During SBT in NICU Infants N/A
Terminated NCT01467076 - Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF) Phase 2
Completed NCT00828243 - Genetic Regulation of Surfactant Deficiency
Completed NCT00556738 - Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn N/A
Not yet recruiting NCT05594030 - Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress
Completed NCT02332304 - Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity. Phase 3
Withdrawn NCT00598429 - Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure Phase 2
Completed NCT04137783 - ABCA3 Gene and RDS in Late Preterm and Term Infants
Completed NCT01941524 - Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations Phase 4
Completed NCT01102543 - Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS) N/A
Completed NCT00501982 - Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study Phase 4
Recruiting NCT05065424 - Premedication for Less Invasive Surfactant Administration Study (PRELISA) Phase 4