Evaluation of feasibility and physiological stability of parents cuddling babies during cooling therapy for hypoxic ischaemic encephalopathy: a quantitative and qualitative study

niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 27 人开始时间: 2020年4月21日最近更新: 2022年8月22日

试验速览

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)

•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

•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

发起方

niversity Hospitals Bristol NHS Foundation Trust