A Feasibility Randomised Controlled Trial to determine feasibility of a neonatal swaddle bathing intervention for preterm infants in a neonatal unit: The NeoBath study protocol
Background Infection is common in neonatal units, particularly among preterm or unwell term infants who have underdeveloped immune systems. While bathing may help reduce infection risk, the optimal frequency of bathing this population remains unclear. Establishing an evidence-based bathing schedule could improve short-and long-term outcomes for infants. Additionally, involving parents in bathing routines may enhance parental engagement in their baby’s care and support preparation for discharge home. Aim The aim of this study is to determine the feasibility and acceptability of a neonatal swaddled bathing intervention for newborn infants admitted to a neonatal unit. Design This is a parallel group, open-label, single centre, feasibility randomised controlled trial (RCT), with embedded qualitative study. Methods Babies will be randomised to either bathing every 4 days (n = 25) or bathing every 7 days (n = 25), using a swaddled technique. Skin swabs will be collected before and after each bath. Semi-structured online interviews will be conducted with parents (n = 5) prior to discharge from the neonatal unit, and with healthcare professionals (n = 5) who have cared for babies and their families who have participated in the study. Conclusion The results of this study will determine whether a larger multicentre RCT would be achievable in this population. This would identify whether there is an association between bathing frequency and a subsequent reduction in neonatal sepsis. Trial registration The study has been retrospectively registered with the ISRCTN (ISRCTN10089507 4 th March 2026). Protocol version: 1.3
Authors
- Aviva Petrie (ORCID: https://orcid.org/0000-0002-5236-4741)
- Laurence Galland
- Katie Gallagher (ORCID: https://orcid.org/0000-0002-6847-9594)
- Kathy Chant (ORCID: https://orcid.org/0009-0007-4276-4622)
- Christina Kortsalioudaki
- Shanom Ali (ORCID: https://orcid.org/0000-0003-3392-7657)
- Subhabrata Mitra (ORCID: https://orcid.org/0000-0002-4304-4594)
- Betty Hutchon
- Ben Wills-Eve
- Hailey Fulkerson
- Nicola Harris
- Cidalia Da Costa
- Beverley Hicks
- Abishek Das
- Jos M Latour
- Leah Healy
- Bronwen Shuttleworth
- Eilis Boyle
- Judith Meek
Institutions
- University College London Hospitals NHS Foundation Trust (GB)
- University of Leicester (GB)
- Curtin University (AU)
- Fudan University (CN)
- Leicester College (GB)
- University Hospitals of Leicester NHS Trust (GB)
- Bliss (GB)
- Zhongshan Hospital (CN)
- Expert System (Italy) (IT)
- The London College (GB)
- University College London (GB)
- University of Plymouth (GB)
Publication Details
- Journal
- NIHR Open Research
- Published
- 2026-09-08
- DOI
- https://doi.org/10.3310/nihropenres.14319.1
- Primary Topic
- Neonatal skin health care
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Institute for Health and Care Research
- Department of Health and Social Care