Fluid Balance Study in Sick Neonates

Very Low Birth Weight Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962754
• Other study ID #: NL26894.075.09
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2009
• Last updated: April 8, 2014
• Start date: June 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2014
• Source: Princess Amalia Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Birth Weight
• Very Low Birth Weight Infant

Intervention

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

Locations

Country	Name	City	State
Netherlands	Princess Amalia Children's Clinic	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Princess Amalia Children's Clinic

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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. — View Citation

Daffurn K, Hillman KM, Bauman A, Lum M, Crispin C, Ince L. Fluid balance charts: do they measure up? Br J Nurs. 1994 Sep 8-21;3(16):816-20. — View 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. — View 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. — View Citation

Pflaum SS. Investigation of intake-output as a means of assessing body fluid balance. Heart Lung. 1979 May-Jun;8(3):495-8. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Use of Diuretics	prescription of diuretic therapy	during days of admission	No
Secondary	Complications	notifications of complications	duration of admission	Yes