Neonatal hypoxic ischaemic encephalopathy Neonatal Diseases Neonatal hypoxic ischaemic encephalopathy
Conditions
Interventions
Parents of babies undergoing therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy as per the regional protocol will be recruited after informed consent during the cooling period to cu
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. During pre, cuddle and post -cuddle period: 1.1. Rectal temperature measured using a temperature probe inserted in the rectum 1.2. Mean airway pressure measured using the ventilator and patient monitor 1.3. Fraction of inspired oxygen measured using the ventilator and patient monitor 1.4. Heart rate measured from chest electrodes 1.5. Blood pressure measured from chest electrodes 1.6. Regional cerebral oxygenation measured using near infra-red spectroscopy 1.7. Interburst interval in the aEEG measured using the interburst interval from the amplitude-integrated electroencephalogram 2. Depression measured using the Edinburgh Postnatal Depression Scale (EPDS) at 5-7 days and 8 weeks 3. Mother-infant bonding scale (MIBS) at 5-7 days and 8 weeks 4. Adverse events occurring during the cuddle events measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Thematic analysis of the semi-structured interviews to explore views and experiences of parents and staff participating in the CoolCuddle | — |
Countries
England, United Kingdom
Outcome results
None listed