Skip to main content
Clinical Trials/NCT00962754
NCT00962754CompletedPhase 4

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

Princess Amalia Children's Clinic2 sites in 1 country170 target enrollmentStarted: June 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
170
Locations
2
Primary Endpoint
Duration of Admission at the Ward in Days

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Participant)

Eligibility Criteria

Ages
— to 28 Days (Child)
Sex
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

Outcomes

Primary Outcomes

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 Outcomes

  • Use of Diuretics(during days of admission)
  • Complications(duration of admission)

Investigators

Sponsor
Princess Amalia Children's Clinic
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jolita Bekhof

MD, Pediatrician

Princess Amalia Children's Clinic

Study Sites (2)

Loading locations...

Similar Trials