Fluid Balance Study in Sick Neonates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Princess Amalia Children's Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier:
NCT00962754
First received: August 18, 2009
Last updated: August 19, 2009
Last verified: August 2009

August 18, 2009
August 19, 2009
June 2009
May 2010   (final data collection date for primary outcome measure)
duration of admission at the ward in days [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00962754 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Newborn
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
  • Active Comparator: physician no insight 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.
 
Recruiting
174
May 2010
May 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: J Bekhof, Pediatrician +31384254050 j.bekhof@isala.nl
Contact: P Brand, Pediatrician +31384245050 p.l.p.brand@isala.nl
Netherlands
 
NCT00962754
NL26894.075.09
No
J. 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, medical student University of Groningen
Princess Amalia Children's Clinic
August 2009

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