None listed
Conditions
Brief summary
Babies who have deprived of oxygen during birth can be at risk of brain damage because the blood rushes to the brain to compensate for the lack of oxygen. Cooling has been show to help prevent brain damage. Currently all babies are cooled for 72 hours but it is thought that some babies may benefit from being cooled for longer. Babies in this study will have more frequent ultrasound scans through the soft spot on the head (fontanelle) to monitor blood flow to the brain. Ultrasound scans will occur before cooling, daily whilst cooled, and every hour during rewarming (this takes around 12 hours). Whilst being treated the baby will be monitored by a patient monitor that monitors blood pressure, heart rate and respiration rate and an electroencephalograph (EEG) monitor which records electrical brain activity. The data from the patient monitor and EEG will be collected and analysed for the research. Pathology results and MRI’s may also be included in the research. When the baby is 2, it is normal practice to invite parents of HIE babies to an interview with a Paediatrician to discuss their developmental progress and this study will use the information from this developmental review.
Interventions
Additional measurements of the Resistance Index (RI) are measured with Ultrasound daily whilst cooled and every 0.5 degrees (C) increase in rectal temperature (approximately 2 hourly). After warmed, RI will be measured daily until recovery to normal (1 week maximum).
All available clinical parameters recorded and analysed including (but not limited to) vital signs, pathology results, and aEEG from time of consent until the return of the RI to normal (1 week maximum). Cerebral perfusion using Nea
Additional measurements of the Resistance Index (RI) are measured with Ultrasound daily whilst cooled and every 0.5 degrees (C) increase in rectal temperature (approximately 2 hourly). After warmed, RI will be measured daily until recovery to normal (1 week maximum). All available clinical parameters recorded and analysed including (but not limited to) vital signs, pathology results, and aEEG from time of consent until the return of the RI to normal (1 week maximum). Cerebral perfusion using Near-infrared Spectrometry (NIRS) continuously monitored from time of consent during cooling and re-warming and until RI returns to normal (again 1 week maximum). Analysis of MRI (one MRI after re-warming). Inclusion of 2 year developmental review.
Sponsors
Mercy Hospital for Women
Eligibility
Sex/Gender
All
Age
1 Hours to 48 Hours
Healthy volunteers
No
Inclusion criteria
Near-term or term infants born at 36 weeks' gestation or more with birth weight of >1.8kgs that have had hypothermia treatment started within 6 hours of birth because they have been clinically assessed and deemed suitable for the treatment because there was: * Evidence of acute event around the time of birth Apgar score of 5 or less at 10 minutes after birth, severe acidosis, defined as pH level of less than 7 or base deficit of 16 mmol/L or less (cord blood or any blood gas obtained within 1 h of birth), continued need for resuscitation at 10 minutes after birth and * Evidence of moderate to severe encephalopathy at birth - clinically determined (at least 3 of the following: lethargy, stupor, or coma; abnormal tone or posture; abnormal reflexes [suck, grasp, Moro, gag, stretch reflexes]; decreased or absent spontaneous activity; autonomic dysfunction [including bradycardia, abnormal pupils, apneas]; and clinical evidence of seizures, moderately or severely abnormal amplitudeintegrated electroencephalography (aEEG) background or seizures (CoolCap and TOBY)
Exclusion criteria
Less than 36 weeks gestation or hypothermia treatment not initiated within 6 hours of birth.
Outcome results
None listed