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Completed

NCT Number: NCT00962754

Fluid Balance Study in Sick Neonates

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.

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Key information

Conditions

Very Low Birth Weight Infant

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Princess Amalia Children's Clinic

Zwolle, Overijssel, 8000GK, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physician no insight in the fluid balance chart

Procedure

physician had no insight in the fluid balance chart during the first 3 days of admission of the patient when the balance is recorded

Primary outcomes

  1. 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

  1. Use of Diuretics

    Time frame: during days of admission

    prescription of diuretic therapy

  2. Complications

    Time frame: duration of admission

    notifications of complications

Sponsors and collaborators

Lead sponsor

Princess Amalia Children's Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 20, 2009
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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