NCT00962754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

May 7, 2014

Completed
Last Updated

May 7, 2014

Status Verified

April 1, 2014

Enrollment Period

9 months

First QC Date

August 18, 2009

Results QC Date

January 4, 2012

Last Update Submit

April 8, 2014

Conditions

Very Low Birth Weight Infant

Keywords

recording fluid balancereliabilityutilitysick neonatefluid balanceinpatientsick

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Use of Diuretics

    during days of admission

  • Complications

    duration of admission

Study Arms (2)

physician insight fluid balance

NO INTERVENTION

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

fluid balance data masked to physician

EXPERIMENTAL

physician no insight in the fluid balance chart

Procedure: physician no insight in the fluid balance chart

Interventions

physician no insight in the fluid balance chartPROCEDURE

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

fluid balance data masked to physician

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Sick neonates admitted to the neonatal ward

You may not qualify if:

  • Admitted elsewhere before admission to the neonatal ward
  • Indication for recording fluid balance
  • Impossibility to measure the weight every day
  • No consent parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Amalia Children's Clinic

Zwolle, Overijssel, 8000GK, Netherlands

Location

Related Publications (8)

  • 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.

    PMID: 7950261BACKGROUND

  • 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.

    PMID: 11882111BACKGROUND

  • 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.

    PMID: 10826233BACKGROUND

  • 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.

    PMID: 16426933BACKGROUND

  • 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.

    PMID: 12853687BACKGROUND

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

    PMID: 254670BACKGROUND

  • 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.

    PMID: 18777823BACKGROUND

  • 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.

    PMID: 23635344DERIVED

Limitations and Caveats

* lack of a more reliable assessment method of fluid status, for example central venous pressure or body impedance measurements * moderate disease severity * unequal distribution of premature infants amongst the study groups

Results Point of Contact

Title
Dr. J. Bekhof
Organization
Princess Amalia Children's Clinic, Isala Klinieken
j.bekhof@isala.nl
0031-38-4245050

Study Officials

  • J Bekhof, pediatrician

    Princess Amalia Children's Clinic

    STUDY DIRECTOR

  • Y v Asperen, MD

    University of Groningen

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Pediatrician

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 20, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 7, 2014

Results First Posted

May 7, 2014

Record last verified: 2014-04

Locations

NL(1)