Fluid Balance Study in Sick Neonates

April 8, 2014 updated by: Jolita Bekhof, Princess Amalia Children's Clinic

Reliability and Utility of Fluid Balance Charting in Neonates Admitted to the Pediatric Ward.

The purpose of this study is to determine if routinely recording fluid balance in sick neonates admitted to the pediatric ward is reliable and useful. The investigators' hypothesis is that it is not useful and reliable.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fluid balance charts are commonly used, in the Netherlands, to assess patient fluid volume status. Some disadvantages of recording fluid intake and output are that it is time-consuming and complex. If it would give reliable and accurate information about the fluid volume status there would be a good reason for all this effort. In the few researches that have investigated this subject a low correlation has been found between the fluid balance and the weight changes of an adult patient. Own experience gives reasons to doubt about the reliability of the fluid balance in children, not rarely there is a discrepancy between the fluid balance and the weight measurement. We are interested in the relevance of recording fluid balance in neonates.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 4

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

  • Netherlands
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8000GK
        • Princess Amalia Children's Clinic

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

No older than 4 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sick neonates admitted to the neonatal ward

Exclusion Criteria:

  • Admitted elsewhere before admission to the neonatal ward
  • Indication for recording fluid balance
  • Impossibility to measure the weight every day
  • No consent parents

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: physician insight fluid balance
physician has insight in fluid balance chart, this is standard practice
EXPERIMENTAL: fluid balance data masked to physician
physician no insight in the fluid balance chart
Procedure: physician no insight in the fluid balance chart
physician had no insight in the fluid balance chart during the first 3 days of admission of the patient when the balance is recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Admission at the Ward in Days
Time Frame: 1-8 months
Duration of hospital stay in days or duration of admission at the pediatric ward in days
1-8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Diuretics
Time Frame: during days of admission
prescription of diuretic therapy
during days of admission
Complications
Time Frame: duration of admission
notifications of complications
duration of admission

Collaborators and Investigators

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

Sponsor

Princess Amalia Children's Clinic

Investigators

  • Study Director: J Bekhof, pediatrician, Princess Amalia Children's Clinic
  • Principal Investigator: Y v Asperen, MD, University of Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

August 19, 2009

First Posted (ESTIMATE)

August 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL26894.075.09

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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