ArticleBMJ open2024
Embedding the 'CoolCuddle' intervention for infants undergoing therapeutic hypothermia for hypoxic-ischaemic encephalopathy in NICU: an evaluation using normalisation process theory.
Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Factors Influencing Breastfeeding Outcomes Following Neonatal Hypoxic Ischaemic Encephalopathy: A Mixed Methods Systematic Review.Journal of human lactation : official journal of International Lactation Consultant Association · 2026Pooled it
- The POETIC (PrOcess Evaluation of Trials In Critical care) Framework: A Structured Approach for Designing and Conducting Process Evaluations in Critical Care Trials.Critical care explorations · 2025Article
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesNewborn infants exposed to lack of oxygen and blood flow to the brain around birth may develop brain dysfunction (hypoxic-ischaemic encephalopathy-HIE). These infants undergo 72 hours of cooling therapy and most are not held by their parents in the UK. We examined the implementation of 'CoolCuddle', identifying factors that impact embedding of this complex intervention in neonatal intensive care units (NICUs) across England.
designProcess evaluation and qualitative study using a standard questionnaire and interviews. Normalisation Process Theory (NPT) core constructs were used to assess relevant issues to staff embedding 'CoolCuddle', to discern change over time and different settings. Qualitative interviews provided valuable contextual exploration of implementation. SETTING AND
participantsSix tertiary NICUs in England. Thirty-seven families with a newborn baby undergoing cooling therapy for HIE were recruited from September 2022 to August 2023; 17 NICU staff Normalisation MeAsure Development (NoMADs) at six NICUs over 6 months were included; 14 neonatal/research nurses from three participating NICUs were interviewed.
interventionThe family-centred intervention 'CoolCuddle' was developed to enable parents to hold their infant during cooling, without affecting the cooling therapy or intensive care. OUTCOME MEASURES: NoMAD questionnaires at three timepoints over 6 months and NPT informed qualitative interviews.
resultsNoMAD questionnaires at baseline showed more variation between units, for intervention acceptability, than those at 3 and 6 months. Qualitative data highlighted that staff understood the benefits of CoolCuddle but were apprehensive due to perceived risks involved in moving cooling babies. A rigorous standard operating procedure was flexible enough to incorporate the use of local processes and equipment and provided the relevant procedural knowledge to deliver CoolCuddle safely.
conclusionsThe CoolCuddle intervention can be implemented safely under the supervision of standard neonatal teams as part of usual practice in diverse NICU settings in England. The importance of having a rigorous standard operating procedure, which can be adapted to support local settings, is highlighted. TRIAL REGISTRATION NUMBER: ISRCTN10018542; Results: registered on 30 August 2022.
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