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

March 9, 2012 updated by: Stefanie Junge, University of Jena

Study of Possible Effects of Intravenous Fluid Supplementation on Serum Bilirubin Levels and Cardiorespiratory Parameters in Preterm Infants During Phototherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Jena, Germany, 07743
        • University Hospital of Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hyperbilirubinemia

Exclusion Criteria:

  • Preterm infants > 33 weeks of gestation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within one week after onset of phototherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (Estimate)

March 12, 2012

Study Record Updates

Last Update Posted (Estimate)

March 12, 2012

Last Update Submitted That Met QC Criteria

March 9, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2127-10/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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