CoolCuddle-2 study: Embedding CoolCuddle into NICUs

Process evaluation of embedding the CoolCuddle intervention into neonatal intensive care units.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10018542

Enrollment

Registered

2022-08-30

Start date

2022-08-01

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal hypoxic ischaemic encephalopathy (HIE) Pregnancy and Childbirth

Interventions

Process evaluation of implementing CoolCuddle intervention that allows parents to cuddle babies whilst undergoing therapeutic hypothermia and intensive care for neonatal hypoxic-ischaemic encephalopat

Eligibility

Sex/Gender

All

Inclusion criteria

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:

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 2. Views of neonatal nurses and clinicians regarding barriers and facilitators of embedding CoolCuddle into routine practice measured using focus groups or staff interviews at the end of recruitment at each site 3. Views of parents on the integration of CoolCuddle into infant care practices at the four sites will be measured using telephone or virtual interviews after parents complete the questionnaires at 8 weeks 4. Stability and deliverability of CoolCuddle for the recruited infants in different NICUs measured using the following: (there is no timepoint here, it is the measure for the recruited infants or the recruitment period which will vary for each site) 4.1. Number and duration of cuddles throughout the NICU admission 4.2. Difference in mean core temperature, oxygen requirement, heart rate, and blood pressure between pre-cuddle, cuddle, and post-cuddle epochs 4.3. Safety issues and instigation of mitigating factors during the recruitment period 4.4. Frequency of stopping cuddles as per SOP and reasons for this (thermal control, endotracheal tube, vascular or urinary catheter, EEG electrode dislodgement) during the recruitment period 4.5. Proportion of women breastfeeding, median Edinburgh Postnatal Depression Scale (EPDS) scores, the proportion at risk of depression (EPDS score =13), and Mother-to-Infant Bonding Scale (MIBS) scores at discharge and 8 weeks	—

Measure

Time frame

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 2. Views of neonatal nurses and clinicians regarding barriers and facilitators of embedding CoolCuddle into routine practice measured using focus groups or staff interviews at the end of recruitment at each site 3. Views of parents on the integration of CoolCuddle into infant care practices at the four sites will be measured using telephone or virtual interviews after parents complete the questionnaires at 8 weeks 4. Stability and deliverability of CoolCuddle for the recruited infants in different NICUs measured using the following: (there is no timepoint here, it is the measure for the recruited infants or the recruitment period which will vary for each site) 4.1. Number and duration of cuddles throughout the NICU admission 4.2. Difference in mean core temperature, oxygen requirement, heart rate, and blood pressure between pre-cuddle, cuddle, and post-cuddle epochs 4.3. Safety issues and instigation of mitigating factors during the recruitment period 4.4. Frequency of stopping cuddles as per SOP and reasons for this (thermal control, endotracheal tube, vascular or urinary catheter, EEG electrode dislodgement) during the recruitment period 4.5. Proportion of women breastfeeding, median Edinburgh Postnatal Depression Scale (EPDS) scores, the proportion at risk of depression (EPDS score =13), and Mother-to-Infant Bonding Scale (MIBS) scores at discharge and 8 weeks

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026