The RAINBoW Study
Research type
Research Study
Full title
The RAINBoW Study. A feasibility RCT to compare additional information on neonatal body water distribution (RAINBoW) with standard care.
IRAS ID
342736
Contact name
Colin Morgan
Contact email
Sponsor organisation
LIVERPOOL WOMEN'S NHS FOUNDATION TRUST
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The research is a feasibility randomised control trial that aims to find out if the use of a body composition device is useful to members of the clinical team when making decisions about how much/how little fluid to give to premature or sick term babies who are receiving their fluid via a drip.
Half the babies (85) will have a body composition reading taken and half will not (85). The usefulness will be judged on how well the serum sodium level has been controlled over the first 14 days of life. Sodium is a good marker of how well or not well the baby is hydrated.
There will also be a detailed exploration of how parents and clinicians feel about the body composition device. There will be observations of ward round interactions and clinician and parent interviews to ask their opinion about if the machine is useful, practical or if the machine was used every day.
The practical aspects of carrying out the study will also be evaluated, specifically looking at the recruitment and consent process, data collection methods and the suitability of the primary outcome. The aim is to see if this study is fit for purpose and if a bigger multicenter study could follow this work.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
24/YH/0230
Date of REC Opinion
21 Oct 2024
REC opinion
Favourable Opinion