CoolCuddle study

• Research type

  Research Study

• Full title

  “CoolCuddle” study: Development and evaluation of a standard procedure of a cuddling process allowing parents to cuddle their babies undergoing cooling therapy.

• IRAS ID

  257430

• Contact name

  Ela Chakkarapani

• Contact email

  ela.chakkarapani@bristol.ac.uk

• Sponsor organisation

  Research and Innovation, University Hospitals Bristol NHS Foundation Trust

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  Newborn babies who suffer from brain injury due to lack of oxygen around birth (hypoxic-ischaemic encephalopathy) receive three days of cooling therapy and intensive care commenced within 6 hours of age to reduce long-term disabilities and death. Early need for cooling therapy separates the baby from their parents and the current practice does not allow parents to cuddle their babies during cooling due to concerns of destabilising cooling treatment and intensive care. This practice is reported to impair parent-infant bonding, which might worsen the cognitive development of cooled infants.
  Other babies receiving intensive care are routinely cuddled by parents to promote parent-infant interaction. In this study, we aim to develop a cuddling process suitable for cooling babies modified from the process used for other babies as “CoolCuddle” protocol (stage 1) and evaluate its impact on cooling therapy, intensive care, parental mood and bonding (stage 2) and incorporate the refined “CoolCuddle” protocol into the cooling therapy guideline (stage 3). The study will be conducted at St Michael’s and Southmead neonatal intensive care units in Bristol. In Stage 1 (3 months), we will audio record cuddling process on 4-6 parent-infant pairs having up to 4 cuddles with each cuddling lasting up to 2 hours. The recording will be analysed to develop a CoolCuddle protocol. In stage 2 (12 months), we will assess the stability of baby’s temperature, heart, breathing and brain function between the cuddle and before and after cuddle period on 20-24 parents-infant pairs. We will record any problems identified during cuddling and compare breast feeding rate, mother’s mood and parent-infant bonding and attachment scores measured at 7-10 days of age and at 8 weeks with existing information. In stage 3 (3 months), we will incorporate a modified “CoolCuddle” protocol into the cooling therapy guideline.

• REC name

  HSC REC A

• REC reference

  19/NI/0143

• Date of REC Opinion

  15 Aug 2019

• REC opinion

  Further Information Favourable Opinion