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

NCT ID: NCT00739115

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-08-31

Brief 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.

Conditions

Respiratory Distress Syndrome, Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Heliox gas

Intervention Type: OTHER

Heliox gas used in conjunction with nasal CPAP

2

Conventional nasal CPAP for the first 72 hours of life

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Heliox gas

Heliox gas used in conjunction with nasal CPAP

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Cyanotic congenital heart disease
• Congenital malformation

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 12 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hawaii Community Foundation

OTHER

Sponsor Role: collaborator

Hawaii Medical Service Association

OTHER

Sponsor Role: collaborator

Hawaii Pacific Health

OTHER

Sponsor Role: lead

Responsible Party

Charles R. Neal,

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taylor Sawyer, DO

Role: STUDY_DIRECTOR

Kapiolani Medical Center For Women & Children

Locations

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

07-026-1-HPH1

Identifier Type: -

Identifier Source: org_study_id