Fluid Balance Study in Sick Neonates

Phase 4

Completed

• Conditions: Very Low Birth Weight Infant

• Registration Number: NCT00962754
• Lead Sponsor: Princess Amalia Children's Clinic

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-20
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2012-01-04
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-08
• Last Update Submitted: 2014-04-08
• Results First Posted: 2014-05-07
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of Admission at the Ward in Days	1-8 months	Duration of hospital stay in days or duration of admission at the pediatric ward in days

Secondary Outcome Measures

Name	Time	Method
Use of Diuretics	during days of admission	prescription of diuretic therapy
Complications	duration of admission	notifications of complications

Trial Locations

Locations (1)

Princess Amalia Children's Clinic; 🇳🇱 Zwolle, Overijssel, Netherlands