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

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739115
• Other study ID #: 07-026-1-HPH1
• Status: Completed
• Phase: N/A
• First received: August 20, 2008
• Last updated: August 25, 2015
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: August 2015
• Source: Hawaii Pacific Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Hours

Eligibility

Inclusion Criteria:

• Gestational age < 33 weeks

• Receiving CPAP from the time of delivery

Exclusion Criteria:

• Cyanotic congenital heart disease

• Congenital malformation

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

Intervention

Other:
• Heliox gas
Heliox gas used in conjunction with nasal CPAP

Locations

Country	Name	City	State
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii

Sponsors (3)

Lead Sponsor	Collaborator
Hawaii Pacific Health	Hawaii Community Foundation, Hawaii Medical Service Association (HMSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal CPAP failure resulting in endotracheal intubation		72 hours of life	No
Secondary	Bronchopulmonary dysplasia		36 weeks corrected gestational age	No
Secondary	Hospital length of stay		At hospital discharge	No
Secondary	Death		Prior to hospital discharge	Yes
Secondary	Pulmonary interstitial emphysema		72 hours of life	Yes
Secondary	Pneumothorax		72 hours of life	Yes