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

August 18, 2009
April 8, 2014
June 2009
March 2010   (final data collection date for primary outcome measure)
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
duration of admission at the ward in days [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00962754 on ClinicalTrials.gov Archive Site
  • 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
  • agreement between fluid balance and weight measurement [ Time Frame: daily during first 3 days of admission of patient ] [ Designated as safety issue: No ]
  • use of diuretics [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • complications [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Fluid Balance Study in Sick Neonates
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Very Low Birth Weight Infant
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
  • 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
    Intervention: Procedure: physician no insight in the fluid balance chart

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
up to 28 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00962754
NL26894.075.09
No
Jolita Bekhof, Princess Amalia Children's Clinic
Princess Amalia Children's Clinic
Not Provided
Study Director: J Bekhof, pediatrician Princess Amalia Children's Clinic
Principal Investigator: Y v Asperen, MD University of Groningen
Princess Amalia Children's Clinic
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP