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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01550627
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : March 12, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hyperbilirubinemia Other: extra fluid/iv fluid supplementation during phototherapy Other: Non extra fluid Early Phase 1

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2007
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. The maximum total serum bilirubin levels [ Time Frame: within one week after onset of phototherapy ]
    The maximum total serum bilirubin levels within on week after onset of phototherapy


Eligibility Criteria

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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperbilirubinemia

Exclusion Criteria:

  • Preterm infants > 33 weeks of gestation
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550627


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

Responsible Party: Stefanie Junge, (MD), University of Jena
ClinicalTrials.gov Identifier: NCT01550627     History of Changes
Other Study ID Numbers: 2127-10/09
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012

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

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