Embedding the 'CoolCuddle' intervention for infants undergoing therapeutic hypothermia for hypoxic-ischaemic encephalopathy in NICU: an evaluation using normalisation process theory.

Newborn 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. Process 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. Six 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. The family-centred intervention 'CoolCuddle' was developed to enable parents to hold their infant during cooling, without affecting the cooling therapy or intensive care. NoMAD questionnaires at three timepoints over 6 months and NPT informed qualitative interviews. NoMAD 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. The 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. ISRCTN10018542; Results: registered on 30 August 2022.

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Competing interests: None declared.