Development and evaluation of a standard procedure of a cuddling process allowing parents to cuddle their babies undergoing cooling therapy

Not Applicable

Completed

• Conditions: eonatal hypoxic ischaemic encephalopathy; Neonatal Diseases; Neonatal hypoxic ischaemic encephalopathy

• Registration Number: ISRCTN10198406
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/35510511/ observational study results (added 08/08/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35332621/ qualitative interview results (added 08/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-21
• Study Completion: 2021-04-01
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Newborn infants born at gestation = 36+0 weeks
1.1. Undergoing whole-body cooling for hypoxic-ischemic encephalopathy as per the national and south west neonatal network cooling therapy pathway and their parents who consent to participate in the study
1.2. Cooling provided by a cooling device offering servo-controlled cooling using a wrap or blanket covering the whole body
1.3. Receiving intensive care and will have probes monitoring core temperature and scalp EEG electrodes, may have central or peripheral arterial or venous catheter and may have a urinary catheter
2. Parents of eligible babies

Exclusion Criteria

1. Needing fraction of inspired oxygen (FiO2) >70%
2. Receiving high-frequency oscillatory ventilation
3. Requiring a mean airway pressure > 12cm H2O
4. Receiving inhaled nitric oxide for persistent pulmonary hypertension
5. >1 chest drain inserted for pneumothorax
6. Receiving three or more inotrope infusions
7. Congenital anomalies such as hydrops fetalis and congenital diaphragmatic hernia
8. Non-English speaking parents
9. If potential participants are involved in another intervention study, an eligibility check to participate in the CoolCuddle” study will be needed before recruitment
10. If a baby excluded during the initial screening because of criteria 1 to 6, becomes eligible later during the cooling period due to resolution of those criteria, the baby can be screened again for participation in the study

Study & Design

• Study Type: Observational
• Study Design: Not specified