Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stefanie Junge, University of Jena
ClinicalTrials.gov Identifier:
NCT01550627
First received: February 7, 2012
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Hyperbilirubinemia
Other: extra fluid/iv fluid supplementation during phototherapy
Other: Non extra fluid
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Possible Effects of Intravenous Fluid Supplementation on Serum Bilirubin Levels and Cardiorespiratory Parameters in Preterm Infants During Phototherapy

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • The maximum total serum bilirubin levels [ Time Frame: within one week after onset of phototherapy ] [ Designated as safety issue: Yes ]
    The maximum total serum bilirubin levels within on week after onset of phototherapy


Enrollment: 60
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Other: 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.
Placebo Comparator: 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.
Other: 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.

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
  Eligibility

Ages Eligible for Study:   up to 1 Week
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperbilirubinemia

Exclusion Criteria:

  • Preterm infants > 33 weeks of gestation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01550627

Locations
Germany
University Hospital of Jena
Jena, Germany, 07743
Sponsors and Collaborators
University of Jena
  More Information

No publications provided

Responsible Party: Stefanie Junge, (MD), University of Jena
ClinicalTrials.gov Identifier: NCT01550627     History of Changes
Other Study ID Numbers: 2127-10/09
Study First Received: February 7, 2012
Last Updated: March 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
preterm infants < 32 weeks of gestation

Additional relevant MeSH terms:
Hyperbilirubinemia
Pathologic Processes
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014