Fluid Balance Study in Sick Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jolita Bekhof, Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier:
NCT00962754
First received: August 18, 2009
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Very Low Birth Weight Infant
Procedure: physician no insight in the fluid balance chart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Reliability and Utility of Fluid Balance Charting in Neonates Admitted to the Pediatric Ward.

Resource links provided by NLM:


Further study details as provided by Princess Amalia Children's Clinic:

Primary Outcome Measures:
  • Duration of Admission at the Ward in Days [ Time Frame: 1-8 months ] [ Designated as safety issue: No ]
    Duration of hospital stay in days or duration of admission at the pediatric ward in days


Secondary Outcome Measures:
  • Use of Diuretics [ Time Frame: during days of admission ] [ Designated as safety issue: No ]
    prescription of diuretic therapy

  • Complications [ Time Frame: duration of admission ] [ Designated as safety issue: Yes ]
    notifications of complications


Enrollment: 170
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00962754

Locations
Netherlands
Princess Amalia Children's Clinic
Zwolle, Overijssel, Netherlands, 8000GK
Sponsors and Collaborators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jolita Bekhof, MD, Pediatrician, Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier: NCT00962754     History of Changes
Other Study ID Numbers: NL26894.075.09
Study First Received: August 18, 2009
Results First Received: January 4, 2012
Last Updated: April 8, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Princess Amalia Children's Clinic:
recording fluid balance
reliability
utility
sick neonate
fluid balance
inpatient
sick

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014