Fluid Balance Study in Sick Neonates

Princess Amalia Children's Clinic

Status and phase: Completed; Phase 4

Conditions: Very Low Birth Weight Infant

Treatments: Procedure: physician no insight in the fluid balance chart

Study type: Interventional

Funder types: Other

Identifiers

NCT00962754

NL26894.075.09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

physician insight fluid balance

No Intervention group

Description:

physician has insight in fluid balance chart, this is standard practice

fluid balance data masked to physician

Experimental group

Description:

physician no insight in the fluid balance chart

Treatment:

Procedure: physician no insight in the fluid balance chart