ISRCTN10198406
Completed
未知
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 sites27 target enrollmentApril 21, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospitals Bristol NHS Foundation Trust
- Enrollment
- 27
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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