Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT02250079 |
Date of registration:
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08/09/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Polyethylene Body Bags as an Alternative to Radiant Heat Lamp During the Neonatal Adaptation in Infants Older Than 29 Weeks
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Scientific title:
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Features and Differences Between Neonates Undergoing Body Bag With Polyethylene and Conventional Drying During Neonatal Adaptation in Maternal and Child Headquarters Hospital and the Victoria Hospital Engativá, Bogotá, 2013 |
Date of first enrolment:
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June 2013 |
Target sample size:
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100 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02250079 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Colombia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Inborn neonates with both a gestational age >29 weeks
Exclusion Criteria:
- Abdominal wall defect, myelomeningocele, major congenital anomaly, or blistering skin
disorder
Age minimum:
29 Weeks
Age maximum:
42 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neonatal Adaptation
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Intervention(s)
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Device: Conventional treatment
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Device: polyethylene plastic bag
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Primary Outcome(s)
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Temperature
[Time Frame: 10 minutes]
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Humidity
[Time Frame: 10 minutes]
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Secondary Outcome(s)
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Both, Hypothermia or Hyperthermia
[Time Frame: 10 minutes]
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Secondary ID(s)
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polyethylene29
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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