The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Hawaii Pacific Health.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hawaii Pacific Health
Collaborators:
Hawaii Community Foundation
Hawaii Medical Service Association (HMSA)
Information provided by:
Hawaii Pacific Health
ClinicalTrials.gov Identifier:
NCT00739115
First received: August 20, 2008
Last updated: August 5, 2011
Last verified: February 2009
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 20, 2008 | ||||||||
| Last Updated Date | August 5, 2011 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Nasal CPAP failure resulting in endotracheal intubation [ Time Frame: 72 hours of life ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00739115 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study | ||||||||
| Official Title ICMJE | The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Respiratory Distress Syndrome, Newborn | ||||||||
| Intervention ICMJE | Other: Heliox gas
Heliox gas used in conjunction with nasal CPAP |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 12 Hours | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00739115 | ||||||||
| Other Study ID Numbers ICMJE | 07-026-1-HPH1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Charles Neal MD, PhD, Kapiolani Medical Center for Women and Children | ||||||||
| Study Sponsor ICMJE | Hawaii Pacific Health | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Hawaii Pacific Health | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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