Very Low Birth Weight Infant
Conditions
Keywords
recording fluid balance, reliability, utility, sick neonate, fluid balance, inpatient, sick
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.
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.
Interventions
PROCEDUREphysician 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
Sponsors
Princess Amalia Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Admission at the Ward in Days | 1-8 months | Duration of hospital stay in days or duration of admission at the pediatric ward in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of Diuretics | during days of admission | prescription of diuretic therapy |
| Complications | duration of admission | notifications of complications |
Countries
Netherlands
Participant flow
Recruitment details
Patients were recruited upon admission to our neonatal high care ward from June 2009 to March 2010
Participants by arm
| Arm | Count |
|---|---|
| Physician Insight Fluid Balance physician has insight in the fluid balance data | 86 |
| Physician no Insight Fluid Balance Chart physician does not have insight in the fluid balance data (fluid balance chart is blinded) | 84 |
| Total | 170 |
Baseline characteristics
| Characteristic | Physician no Insight Fluid Balance Chart | Physician Insight Fluid Balance | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 84 Participants | 86 Participants | 170 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 0.01 years STANDARD_DEVIATION 0 | 0.01 years STANDARD_DEVIATION 0 | 0.01 years STANDARD_DEVIATION 0 |
| Region of Enrollment Netherlands | 84 participants | 86 participants | 170 participants |
| Sex: Female, Male Female | 33 Participants | 37 Participants | 70 Participants |
| Sex: Female, Male Male | 51 Participants | 49 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 86 | 0 / 84 |
| serious Total, serious adverse events | 0 / 86 | 0 / 84 |
Outcome results
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
Time frame: 1-8 months
Population: intention to treat analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group (no Insight in Fluid Balance) | Duration of Admission at the Ward in Days | 9 number of days |
| Control Group (Insight in Fluid Balance) | Duration of Admission at the Ward in Days | 8 number of days |
Comparison: We calculated that 85 patients in each group would give a power in excess of 85% to detect a difference of two days or more in the geometric mean length of hospital stay with a two-sided significance level of 0.05.p-value: <0.0595% CI: [0.81, 1.19]t-test, 2 sided
Secondary
Complications
notifications of complications
Time frame: duration of admission
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group (no Insight in Fluid Balance) | Complications | 2 participants |
| Control Group (Insight in Fluid Balance) | Complications | 5 participants |
Secondary
Use of Diuretics
prescription of diuretic therapy
Time frame: during days of admission
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group (no Insight in Fluid Balance) | Use of Diuretics | 0 participants |
| Control Group (Insight in Fluid Balance) | Use of Diuretics | 0 participants |