Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by King Fahad Medical City.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
King Fahad Medical City
Information provided by:
King Fahad Medical City
ClinicalTrials.gov Identifier:
NCT00850902
First received: February 23, 2009
Last updated: March 9, 2009
Last verified: March 2009
| Tracking Information | |||||
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| First Received Date ICMJE | February 23, 2009 | ||||
| Last Updated Date | March 9, 2009 | ||||
| Start Date ICMJE | March 2009 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age. [ Time Frame: 36 weeks postmenstrual age ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00850902 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants | ||||
| Official Title ICMJE | Application of a Different Incubator Humidity Strategy at Birth to Decrease Morbidity and Mortality in Extremely Low Birth (1000 g or Less) Infants | ||||
| Brief Summary | The purpose of this study is to apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants. |
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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 | Extremely Low Birth Weight | ||||
| Intervention ICMJE |
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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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 700 | ||||
| Estimated Completion Date | April 2010 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00850902 | ||||
| Other Study ID Numbers ICMJE | 08-049 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jasim Anabrees, King Fahad Medical City | ||||
| Study Sponsor ICMJE | King Fahad Medical City | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | King Fahad Medical City | ||||
| Verification Date | March 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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