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Fluid Balance Study in Sick Neonates

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962754
First Posted: August 20, 2009
Last Update Posted: May 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jolita Bekhof, Princess Amalia Children's Clinic
  Purpose
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 Intervention Phase
Very Low Birth Weight Infant Procedure: physician no insight in the fluid balance chart Phase 4

Study Type: Interventional
Study Design: 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.

Further study details as provided by Jolita Bekhof, Princess Amalia Children's Clinic:

Primary Outcome Measures:
  • 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:
  • Use of Diuretics [ Time Frame: during days of admission ]
    prescription of diuretic therapy

  • Complications [ Time Frame: duration of admission ]
    notifications of complications


Enrollment: 170
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: August 18, 2009
First Posted: August 20, 2009
Results First Submitted: January 4, 2012
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