Clinical trial NCT00962754: Fluid Balance Study in Sick Neonates
Official title: Reliability and Utility of Fluid Balance Charting in Neonates Admitted to the Pediatric Ward.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Very Low Birth Weight Infant
Keywords: recording fluid balance
reliability
utility
sick neonate
fluid balance
inpatient
sick
Lead sponsor: Princess Amalia Children's Clinic
Sponsor class: OTHER
First posted: 2009-08-20
Enrollment: 170
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of Admission at the Ward in Days
timeFrame: 1-8 months
Secondary outcomes:
measure: Use of Diuretics
timeFrame: during days of admission
measure: Complications
timeFrame: duration of admission
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Princess Amalia Children's Clinic
state: Overijssel
Study officials:
affiliation: Princess Amalia Children's Clinic
name: J Bekhof, pediatrician
role: STUDY_DIRECTOR
affiliation: University of Groningen
name: Y v Asperen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Chung LH, Chong S, French P. The efficiency of fluid balance charting: an evidence-based management project. J Nurs Manag. 2002 Mar;10(2):103-13. doi: 10.1046/j.0966-0429.2001.00296.x.
citation: Wise LC, Mersch J, Racioppi J, Crosier J, Thompson C. Evaluating the reliability and utility of cumulative intake and output. J Nurs Care Qual. 2000 Apr;14(3):37-42. doi: 10.1097/00001786-200004000-00005.
citation: Eastwood GM. Evaluating the reliability of recorded fluid balance to approximate body weight change in patients undergoing cardiac surgery. Heart Lung. 2006 Jan-Feb;35(1):27-33. doi: 10.1016/j.hrtlng.2005.06.001.
citation: Mank A, Semin-Goossens A, Lelie Jv, Bakker P, Vos R. Monitoring hyperhydration during high-dose chemotherapy: body weight or fluid balance? Acta Haematol. 2003;109(4):163-8. doi: 10.1159/000070964.
citation: Pflaum SS. Investigation of intake-output as a means of assessing body fluid balance. Heart Lung. 1979 May-Jun;8(3):495-8.
citation: Scales K, Pilsworth J. The importance of fluid balance in clinical practice. Nurs Stand. 2008 Jul 30-Aug 5;22(47):50-7; quiz 58, 60. doi: 10.7748/ns2008.07.22.47.50.c6634.
citation: Bekhof J, van Asperen Y, Brand PL. Usefulness of the fluid balance: a randomised controlled trial in neonates. J Paediatr Child Health. 2013 Jun;49(6):486-92. doi: 10.1111/jpc.12214. Epub 2013 May 2.