Back to resultsEffect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
Primary Purpose
Hyperbilirubinemia
Status
Completed
Phase
Early Phase 1
Locations
Germany
Study Type
Interventional
Intervention
extra fluid/iv fluid supplementation during phototherapy
Non extra fluid
Sponsored by
About this trial
This is an interventional treatment trial for Hyperbilirubinemia focused on measuring preterm infants < 32 weeks of gestation
Eligibility Criteria
Inclusion Criteria:
- Hyperbilirubinemia
Exclusion Criteria:
- Preterm infants > 33 weeks of gestation
Sites / Locations
- University Hospital of Jena
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
extra-fluid
non extra fluid (control group)
Arm Description
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 control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake.
Outcomes
Primary Outcome Measures
The maximum total serum bilirubin levels
The maximum total serum bilirubin levels within on week after onset of phototherapy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01550627
Brief Title
Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
Official Title
Study of Possible Effects of Intravenous Fluid Supplementation on Serum Bilirubin Levels and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study was to evaluate the influence of a systematic extra intravenous fluid supplementation during phototherapy in comparison to a fluid supplementation due to short term demand in preterm infants.
Detailed Description
60 preterm infants (GA ≤ 32 week) were assigned randomly to either receive a fluid supplementation due to short term demand (control group, n=30;) or a 20% extra fluid supplementation (study group, n=30) during intermediate phototherapy.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbilirubinemia
Keywords
preterm infants < 32 weeks of gestation
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
extra-fluid
Arm Type
Active Comparator
Arm Description
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).
Arm Title
non extra fluid (control group)
Arm Type
Placebo Comparator
Arm Description
The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake.
Intervention Type
Other
Intervention Name(s)
extra fluid/iv fluid supplementation during phototherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non extra fluid
Intervention Description
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.
Primary Outcome Measure Information:
Title
The maximum total serum bilirubin levels
Description
The maximum total serum bilirubin levels within on week after onset of phototherapy
Time Frame
within one week after onset of phototherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hyperbilirubinemia
Exclusion Criteria:
Preterm infants > 33 weeks of gestation
Facility Information:
Facility Name
University Hospital of Jena
City
Jena
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
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