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Fluid Balance Study in Sick Neonates

This study has been completed.
Information provided by (Responsible Party):
Jolita Bekhof, Princess Amalia Children's Clinic Identifier:
First received: August 18, 2009
Last updated: April 8, 2014
Last verified: April 2014
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
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Diagnostic
Official Title: Reliability and Utility of Fluid Balance Charting in Neonates Admitted to the Pediatric Ward.

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 ]
    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 ]
    prescription of diuretic therapy

  • Complications [ Time Frame: duration of admission ]
    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.

Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00962754

Princess Amalia Children's Clinic
Zwolle, Overijssel, Netherlands, 8000GK
Sponsors and Collaborators
Princess Amalia Children's Clinic
Study Director: J Bekhof, pediatrician Princess Amalia Children's Clinic
Principal Investigator: Y v Asperen, MD University of Groningen
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jolita Bekhof, MD, Pediatrician, Princess Amalia Children's Clinic 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

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

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms processed this record on April 28, 2017