Phase 4
N=170
Fluid Balance Study in Sick Neonates
Very Low Birth Weight Infant
Bottom Line
View on ClinicalTrials.gov: NCT00962754 ↗Enrolled (actual)
170
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Duration of Admission at the Ward in Days — 9; 8 number of days — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- physician no insight in the fluid balance chart (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Princess Amalia Children's Clinic
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Admission at the Ward in Days |
9; 8 | <0.05 sig |
| SECONDARY Use of Diuretics |
0; 0 | — |
| SECONDARY Complications |
2; 5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00962754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.