Title: Process evaluation of embedding the CoolCuddle intervention into neonatal intensive care units.
Funder: Department of Health and Social Care

Abstract: Research question What is the optimal process of embedding the CoolCuddle intervention in usual care during therapeutic hypothermia for neonatal hypoxic ischaemic encephalopathy (HIE) involving neonatal staff and parents at diverse Neonatal Intensive Care (NICU) settings? Background Each year over 2000 babies with HIE undergo four days of therapeutic hypothermia and intensive care commenced soon after birth. In usual care, parents are not permitted to cuddle their babies during cooling due to concerns of destabilising the cooling process and intensive care, which affects bonding and breastfeeding, consequently, impacting the intellectual development of children. We have developed the CoolCuddle intervention that enables parents to cuddle their babies during cooling therapy without significantly affecting the cooling therapy or intensive care, when delivered in controlled settings, under supervision of a nurse practitioner. How best to implement the CoolCuddle intervention in usual practice in diverse NICU settings without impacting cooling therapy or safety issues is not known. Aims and Objectives The overarching aim of the study is to assess the process of embedding the CoolCuddle intervention during cooling therapy. Objectives Track intervention implementation in 4 diverse tertiary NICUs using continuous monitoring with the NoMAD Implementation measure based on Normalization Process Theory (NPT). Examine barriers and facilitators for implementing CoolCuddle using NPT informed qualitative interviews with neonatal staff and parents. Evaluate cooling process and intensive care during cuddles, rates of postnatal depression, parent-infant bonding or attachment and breastfeeding at discharge and 8 weeks. Examine safety issues associated with CoolCuddle and develop corrective actions. Methods In this process evaluation study, we will train two nurse champions at 4 diverse NICUs on the CoolCuddle standard operating procedure using the staff training videos, who will then train other nurses usually caring for babies needing therapeutic hypothermia at their site. Each unit will recruit 10-12 parent-infant pairs. Routinely collected temperature and intensive care data will be recorded. Parent-infant bonding and postnatal depression measured using mother-infant bonding scale, paternal postnatal attachment scale and Edinburgh postnatal depression scale, and breastfeeding will be completed by parents at discharge and 8 weeks postpartum using secure online questionnaires. Using the NoMAD instrument, staff and parent interviews we will identify the factors that will enhance or impede the implementation of CoolCuddle in usual practice. Mitigating measures to eliminate any safety issues that may arise during cuddles will be developed. Timelines for delivery We will setup the study between April-June 2022. Process evaluation of CoolCuddle implementation at sites will occur between July 22-March 2023. Refined CoolCudlle guideline will be disseminated between April-June 2023. Anticipated impact and dissemination The refined CoolCuddle guideline containing the factors that would enhance implementation in diverse NICU settings will be disseminated through national and international conferences, publications, charities, NIHR collaborations, national neonatal network meetings and published as a framework in the British Association of Perinatal Medicine website. This work will improve the family integrated care offered to babies with HIE potentially enhancing parent-infant bonding, breastfeeding and intellectual development of children, and staff morale.

Lay abstract: Aim. To find the best way to train and involve staff in using the CoolCuddle method in different intensive care units (NICUs) for newborn babies, by closely monitoring how it is introduced. We will also record baby safety measures and see how parents feel about the cuddles. Background. Each year in the NHS, over 2000 babies with brain injury at birth need intensive care and cooling therapy for four days. During this time, parents cannot hold their babies in case it interferes with the cooling therapy. Not allowing cuddling during this important period can affect the bond between the parents and their baby. This can cause problems with breastfeeding, parent s mental health and the baby s emotional and mental development. We have developed a safe way for parents to cuddle their babies during cooling therapy called CoolCuddle. This allows cooling treatment and intensive care to continue. CoolCuddle can help with breastfeeding, parent-baby bonding, parent mental health and may have other long-term benefits for parents and their new-born. We use a CoolCuddle standard procedure and a safety checklist that has allowed 27 cooled babies to be cuddled safely by their parents at two NHS hospitals. We have also made a training video for staff, and photos of how it works for parents. What we will do. We will use our standard procedure and video to train staff at 4 intensive care units for newborn babies. Staff at each unit will be interviewed every two months to see how well CoolCuddle is being used. Parents will be asked to fill in an online questionnaire, measuring depression, parent-baby bonding and breastfeeding when the baby is 1 and 8 weeks old. Some parents will be interviewed to get their views on CoolCuddle. We will monitor the baby during the cuddles and record any effect on cooling or intensive care and how this is corrected. We will look at differences over time and between units to work out best practice. PPI. Parents (including some who helped develop CoolCuddle) say that mothers and fathers would expect CoolCuddle during cooling. They agreed this study would lead to best practice in rolling out CoolCuddle nationally and avoid risk to babies. We have discussed details of the study and advisory group with parents. Dissemination. We will use national meetings, academic publications and work with parent groups, neonatal charities, NIHR collaborations and research networks to share our findings. We will hold meetings with the UK neonatal network to write the final guidance for the British Association of Perinatal Medicine that can then be included in the national recommendations for cooling therapy. This will help with the roll out of CoolCuddle in the NHS.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH