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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physician no insight in the fluid balance chart | Procedure | physician had no insight in the fluid balance chart during the first 3 days of admission of the patient when the balance is recorded |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Diuretics | prescription of diuretic therapy | during days of admission |
| Complications | notifications of complications | duration of admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Bekhof, pediatrician | Princess Amalia Children's Clinic | Study Director |
| Y v Asperen, MD | University of Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Amalia Children's Clinic | Zwolle | Overijssel | 8000GK | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7950261 | Background | 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. | |
| 11882111 | Background | 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. |
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Patients were recruited upon admission to our neonatal high care ward from June 2009 to March 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Physician Insight Fluid Balance | Physician has insight in the fluid balance chart |
| FG001 | Physician no Insight Fluid Balance Chart | physician does not have insight in the fluid balance chart |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Physician Insight Fluid Balance | physician has insight in the fluid balance data |
| BG001 | Physician no Insight Fluid Balance Chart | physician does not have insight in the fluid balance data (fluid balance chart is blinded) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Admission at the Ward in Days | Duration of hospital stay in days or duration of admission at the pediatric ward in days | intention to treat analysis | Posted | Median | Full Range | number of days | 1-8 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physician Insight Fluid Balance | physician has insight in (full access to) the fluid balance chart data |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J. Bekhof | Princess Amalia Children's Clinic, Isala Klinieken | 0031-38-4245050 | j.bekhof@isala.nl |
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| 10826233 | Background | 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. |
| 16426933 | Background | 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. |
| 12853687 | Background | 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. |
| 254670 | Background | Pflaum SS. Investigation of intake-output as a means of assessing body fluid balance. Heart Lung. 1979 May-Jun;8(3):495-8. |
| 18777823 | Background | 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. |
| 23635344 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Use of Diuretics | prescription of diuretic therapy | Posted | Number | participants | during days of admission |
|
|
|
| Secondary | Complications | notifications of complications | Posted | Number | participants | duration of admission |
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | Physician no Insight Fluid Balance Chart | Physician has no insight in the fluid balance chart data (masked) | 0 | 84 | 0 | 84 |
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