Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
NCT ID: NCT01550627
Last Updated: 2012-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
60 participants
INTERVENTIONAL
2007-11-30
2009-06-30
Brief Summary
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Detailed Description
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Collected data:
* cardiorespiratory parameters(heart rate, blood pressure, SaO2 and capillary refill time, breathing rate, temperature) and a pain score was completed at the first day of phototherapy
* The maximum total serum bilirubin levels (TSB) within one week after onset of phototherapy
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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extra-fluid
The study group received an extra intravenous fluid intake of 20% of the total fluid demand per 24 hours of NaCl 0,9% during each two hour period of phototherapy (12h total per day).
extra fluid/iv fluid supplementation during phototherapy
The study group received an extra intravenous fluid intake of 20% of the total fluid demand per 24 hours of NaCl 0,9% during each two hour period of phototherapy (12h total per day). The extra fluid intake was interrupted during the 12 hours break of phototherapy.
non extra fluid (control group)
The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake.
Non extra fluid
Control placebo The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake.
Interventions
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extra fluid/iv fluid supplementation during phototherapy
The study group received an extra intravenous fluid intake of 20% of the total fluid demand per 24 hours of NaCl 0,9% during each two hour period of phototherapy (12h total per day). The extra fluid intake was interrupted during the 12 hours break of phototherapy.
Non extra fluid
Control placebo The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Week
1 Week
ALL
No
Sponsors
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University of Jena
OTHER
Responsible Party
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Stefanie Junge
(MD)
Locations
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University Hospital of Jena
Jena, Jena, Germany
Countries
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Other Identifiers
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2127-10/09
Identifier Type: -
Identifier Source: org_study_id
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