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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00739115
Other study ID # 07-026-1-HPH1
Secondary ID
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
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