Fluid Balance Study in Sick Neonates
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Princess Amalia Children's Clinic.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Princess Amalia Children's Clinic
Information provided by:
Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier:
NCT00962754
First received: August 18, 2009
Last updated: August 19, 2009
Last verified: August 2009
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 18, 2009 | ||||||||
| Last Updated Date | August 19, 2009 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
duration of admission at the ward in days [ Time Frame: 8 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00962754 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Fluid Balance Study in Sick Neonates | ||||||||
| Official Title ICMJE | Reliability and Utility of Fluid Balance Charting in Neonates Admitted to the Pediatric Ward. | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
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| Condition ICMJE | Newborn | ||||||||
| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 174 | ||||||||
| Estimated Completion Date | May 2010 | ||||||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 28 Days | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00962754 | ||||||||
| Other Study ID Numbers ICMJE | NL26894.075.09 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | J. Bekhof, Princess Amalia Children's Clinic | ||||||||
| Study Sponsor ICMJE | Princess Amalia Children's Clinic | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Princess Amalia Children's Clinic | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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