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Fluid Balance Study in Sick Neonates

Primary Purpose

Very Low Birth Weight Infant

Status

Completed

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

physician no insight in the fluid balance chart

About this trial

This is an interventional diagnostic trial for Very Low Birth Weight Infant focused on measuring recording fluid balance, reliability, utility, sick neonate, fluid balance, inpatient, sick

Eligibility Criteria

undefined - 28 Days (Child)All SexesAccepts 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

Sites / Locations

Princess Amalia Children's Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

physician insight fluid balance

fluid balance data masked to physician

Arm Description

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

physician no insight in the fluid balance chart

Outcomes

Primary Outcome Measures

Duration of Admission at the Ward in Days

Duration of hospital stay in days or duration of admission at the pediatric ward in days

Secondary Outcome Measures

Use of Diuretics

prescription of diuretic therapy

Complications

notifications of complications

Full Information

NCT ID

NCT00962754

First Posted

August 18, 2009

Last Updated

April 8, 2014

Sponsor

Princess Amalia Children's Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00962754

Brief Title

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

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Princess Amalia Children's Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Very Low Birth Weight Infant

Keywords

recording fluid balance, reliability, utility, sick neonate, fluid balance, inpatient, sick

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

physician insight fluid balance

Arm Type

No Intervention

Arm Description

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

Arm Title

fluid balance data masked to physician

Arm Type

Experimental

Arm Description

physician no insight in the fluid balance chart

Intervention Type

Procedure

Intervention Name(s)

physician no insight in the fluid balance chart

Intervention Description

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

Primary Outcome Measure Information:

Title

Duration of Admission at the Ward in Days

Description

Duration of hospital stay in days or duration of admission at the pediatric ward in days

Time Frame

1-8 months

Secondary Outcome Measure Information:

Title

Use of Diuretics

Description

prescription of diuretic therapy

Time Frame

during days of admission

Title

Complications

Description

notifications of complications

Time Frame

duration of admission

10. Eligibility

Sex

All

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J Bekhof, pediatrician

Organizational Affiliation

Princess Amalia Children's Clinic

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Y v Asperen, MD

Organizational Affiliation

University of Groningen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Princess Amalia Children's Clinic

City

Zwolle

State/Province

Overijssel

ZIP/Postal Code

8000GK

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

7950261

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. doi: 10.12968/bjon.1994.3.16.816.

Results Reference

background

PubMed Identifier

11882111

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.

Results Reference

background

PubMed Identifier

10826233

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.

Results Reference

background

PubMed Identifier

16426933

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.

Results Reference

background

PubMed Identifier

12853687

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.

Results Reference

background

PubMed Identifier

254670

Citation

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

Results Reference

background

PubMed Identifier

18777823

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.

Results Reference

background

PubMed Identifier

23635344

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.

Results Reference

derived

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Fluid Balance Study in Sick Neonates

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