The use of bioelectrical impedance in fluid management decisions within the neonatal population. Neonatal Diseases
Conditions
Interventions
All babies will be randomised to either Bioscan or Standard Care (no Bioscan). This will be carried out on admission by an Advanced Practitioner / Team Leader or Consultant. The randomisation software
Sponsors
Liverpool Women's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Feasibility RCT: All neonates admitted to the Liverpool Women’s Hospital NICU within 24 hours of birth who require intravenous fluid management for the first week of life Embedded Qualitative Study: 4. All clinical staff working in the NICU 5. Parents of babies who are NICU patients enrolled in the study
Exclusion criteria
Exclusion criteria: Feasibility RCT and Embedded Qualitative Study: 1. They a have life limiting condition and the Consultant prognosis is that they will not survive the first week of life 2. They are being nursed in isolation for maternal/infant COVID or another infection, that prevents the device from being used (because of contamination risk) 3. Parents who are unable to understand study information and are deemed unable to make an informed a decision to opt out
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum sodium levels measured using ... at daily intervals for up to 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility and accuracy of patient, staff, and parent recruitment, ability to collect data, and parental and staff consent rates are measured using recruitment and data sets at ongoing intervals 2. Body water distribution (extracellular fluid, intracellular fluid, interstitial fluid, intravascular fluid) is measured using Bioscan daily for 28 days and once weekly until discharge 3. Cumulative daily nutritional intake and fluid balance (carbohydrate/lipid/protein in g/kg and calories in kcal/kg) are measured using nutritional charts on electronic patient record (EPR) daily for 28 days 4. Estimated mean daily blood glucose levels, including insulin use, are measured using routine blood glucose tests on EPR for the first 14 days of life 5. Growth (weekly change in weight, length, and head circumference) is measured using EPR daily for 28 days and then at discharge 6. Mean serum electrolyte levels are measured using routine blood monitoring tests on EPR for the first 14 days of life 7. Weekly change in total body mineral content is measured using routine blood tests on EPR at weekly intervals 8. Mean serum mineral levels and other biochemical measures of bone biochemistry, including parathyroid hormone levels, are measured using routine blood monitoring tests on EPR as clinical condition dictates 9. Duration of respiratory support (both invasive and non-invasive) is measured using EPR daily for 28 days and at discharge 10. Frequency of circulatory support, including inotropic support, hydrocortisone, and fluid boluses, is measured using EPR daily for 28 days and at discharge 11. Duration of IV fluid therapy (days) is measured using EPR daily for 28 days and at discharge 12. Adverse events associated with IV fluid therapy (e.g., extravasation, limb ischemia) are measured using EPR daily for 28 days and at discharge 13. Infant length of stay in the neonatal unit is measured using EPR at discharge 14. Presence of preterm morbidities in the <29-week gestation cohort (e. | — |
Countries
England, United Kingdom
Contacts
Public ContactDiane McCARTER
Outcome results
None listed