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Fluid Balance Study in Sick Neonates

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ClinicalTrials.gov Identifier: NCT00962754
Recruitment Status : Completed
First Posted : August 20, 2009
Results First Posted : May 7, 2014
Last Update Posted : May 7, 2014
Sponsor:
Information provided by (Responsible Party):
Jolita Bekhof, 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.

Condition or disease Intervention/treatment Phase
Very Low Birth Weight Infant Procedure: physician no insight in the fluid balance chart Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Reliability and Utility of Fluid Balance Charting in Neonates Admitted to the Pediatric Ward.
Study Start Date : June 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
No Intervention: physician insight fluid balance
physician has insight in fluid balance chart, this is standard practice
Experimental: fluid balance data masked to physician
physician no insight in the fluid balance chart
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



Primary Outcome Measures :
  1. Duration of Admission at the Ward in Days [ Time Frame: 1-8 months ]
    Duration of hospital stay in days or duration of admission at the pediatric ward in days


Secondary Outcome Measures :
  1. Use of Diuretics [ Time Frame: during days of admission ]
    prescription of diuretic therapy

  2. Complications [ Time Frame: duration of admission ]
    notifications of complications



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962754


Locations
Netherlands
Princess Amalia Children's Clinic
Zwolle, Overijssel, Netherlands, 8000GK
Sponsors and Collaborators
Princess Amalia Children's Clinic
Investigators
Study Director: J Bekhof, pediatrician Princess Amalia Children's Clinic
Principal Investigator: Y v Asperen, MD University of Groningen

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jolita Bekhof, MD, Pediatrician, Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier: NCT00962754     History of Changes
Other Study ID Numbers: NL26894.075.09
First Posted: August 20, 2009    Key Record Dates
Results First Posted: May 7, 2014
Last Update Posted: May 7, 2014
Last Verified: April 2014

Keywords provided by Jolita Bekhof, Princess Amalia Children's Clinic:
recording fluid balance
reliability
utility
sick neonate
fluid balance
inpatient
sick

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms