CoolCuddle-2 study: Embedding CoolCuddle into NICUs
| ISRCTN | ISRCTN10018542 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10018542 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 312535 |
| Protocol serial number | IRAS 312535, CH/2021/7268, CPMS 52790 |
| Sponsor | University Hospitals Bristol NHS Foundation Trust |
| Funders | National Institute for Health and Care Research, Research for Patient Benefit Programme |
- Submission date
- 05/08/2022
- Registration date
- 30/08/2022
- Last edited
- 21/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
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.
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.
The aim of this study is 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.
Who can participate?
Infants aged ≥35 weeks’ gestation undergoing intensive care and cooling therapy for HIE, and their parents.
What does the study involve?
We will use our standard procedure and video to train staff at around 6 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.
What are the possible benefits and risks of participating?
The benefits of participating in the study include early physical and emotional contact between the parents and the babies who are undergoing cooling therapy for birth asphyxia which may help with establishing breastfeeding and potentially influence the long-term development of babies. Risks of participation may include disruption of the intensive care and cooling therapy. Any physical disruption of wires and catheters will be closely monitored and the chances of occurring will be reduced by following a standard procedure. Disruption occurring despite this will be immediately addressed by nurses and doctors and the new measures will be incorporated into the subsequent cuddles. Further, we will be monitoring the temperature, breathing, and heart function to ensure that these measures are stable during cuddle. Our previous study with CoolCuddle intervention did not show any measurable disruption to intensive care, cooling therapy, or adverse effects to babies or parents.
Where is the study run from?
University Hospitals Bristol NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
From July 2022 to March 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) programme (UK)
Who is the main contact?
1. Dr Ela Chakkarapani, ela.chakkarapani@bristol.ac.uk
2. Prof Jenny Ingram, jenny.ingram@bristol.ac.uk
Contact information
Principal investigator
Level D, Neonatal Neuroscience
St Michael's Hospital
Southwell street
Bristol
BS2 8EG
United Kingdom
 ORCID ID |
0000-0003-3380-047X |
|---|---|
| Phone | +44 (0)1173425711 |
| ela.chakkarapani@bristol.ac.uk |
Principal investigator
Office 1.12
1-5 Whiteladies Road
Bristol
BS8 1NU
United Kingdom
| Phone | +44 (0)117 455 4118 |
|---|---|
| jenny.ingram@bristol.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Process evaluation of embedding the CoolCuddle intervention into neonatal intensive care units. |
| Study acronym | CoolCuddle2 Study |
| Study objectives | To assess the process of embedding the CoolCuddle intervention into standard care during cooling therapy for neonatal HIE in the NHS. 1. Track intervention implementation in 4 diverse tertiary NICUs using continuous monitoring with the NoMAD Implementation measure based on NPT (www.normalizationprocess.org). 2. Examine barriers and facilitators for implementing CoolCuddle using NPT informed qualitative interviews with neonatal staff and parents. 3. Evaluate cooling process and intensive care during cuddles, rates of postnatal depression, parent-infant bonding or attachment and breastfeeding at discharge and 8 weeks. 4. Examine safety issues associated with CoolCuddle and develop corrective actions. |
| Ethics approval(s) | Approved 06/06/2022, North West-Greater Manchester West Research Ethics Committee (Meeting held by video-conference via Zoom; +44 (0)2071048384; gmwest.rec@hra.nhs.uk), ref: 22/NW/0141 |
| Health condition(s) or problem(s) studied | Neonatal hypoxic ischaemic encephalopathy (HIE) |
| Intervention | Process evaluation of implementing CoolCuddle intervention that allows parents to cuddle babies whilst undergoing therapeutic hypothermia and intensive care for neonatal hypoxic-ischaemic encephalopathy in different tertiary NICUs in the UK. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Normalisation of the CoolCuddle intervention in 4 NICUs with a refined training package measured using the Normalisation MeAsure Development questionnaire (NoMAD) for each of the four domains of normalisation process theory (NPT) (coherence, cognitive participation, collective action, and reflexive monitoring) at up to 6 timepoints during implementation |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Lower age limit | 35 Weeks |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 37 |
| Key inclusion criteria | Infants, aged ≥35 weeks’ gestation undergoing therapeutic hypothermia using a servo-controlled cooling machine and intensive care for Hypoxic Ischemic Encephalopathy (HIE), and their parents: |
| Key exclusion criteria | 1. Infants whose parents are not able to complete the consent form or questionnaires in English 2. Infants whose parents are aged <16 years |
| Date of first enrolment | 01/08/2022 |
| Date of final enrolment | 31/08/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Tremona Road
Southampton
SO16 6YD
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Metchley Park Road
Birmingham
B15 2TG
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository, Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository managed by the University of Bristol Search and ublished as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/10/2024 | 21/10/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/10/2024: Publication reference added.
14/09/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2023 to 31/08/2023.
2. The overall end date was changed from 04/10/2023 to 31/03/2024.
3. The intention to publish date was changed from 01/12/2023 to 31/03/2025.
4. The plain English summary was updated to reflect these changes.
5. The target number of participants was changed from 50 to 40.
6. The total final enrolment was added.
7. The study participating centres South Tees Hospitals NHS Foundation Trust, Newcastle upon Tyne Hospitals NHS Foundation Trust were added.
29/09/2022: The following changes were made to the trial record:
1. The overall end date was changed from 04/10/2022 to 04/10/2023.
2. The recruitment end date was changed from 30/09/2022 to 30/09/2023.
3. The plain English summary was updated to reflect these changes.
23/08/2022: Trial’s existence confirmed by Health Research Authority (HRA) and Health and Care Research Wales (HCRW).
