Fluid Balance Study in Sick Neonates

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Very Low Birth Weight Infant

Intervention / Treatment
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* Procedure: physician no insight in the fluid balance chart


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: physician insight fluid balance<br>physician has insight in fluid balance chart, this is standard practice | |
| Experimental: fluid balance data masked to physician<br>physician no insight in the fluid balance chart | Procedure: physician no insight in the fluid balance chart<br>* physician had no insight in the fluid balance chart during the first 3 days of admission of the patient when the balance is recorded<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Admission at the Ward in Days | Duration of hospital stay in days or duration of admission at the pediatric ward in days | 1-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Diuretics | prescription of diuretic therapy | during days of admission | 
| Complications | notifications of complications | duration of admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recording fluid balance, reliability, utility, sick neonate, fluid balance, inpatient, sick