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Barking",{"type":65,"coordinates":336},[298,299],{"lat":299,"lon":298},[339],{"name":340,"role":51,"phone":27,"phoneExt":27,"email":341},"Ambalika Das","ambalika.das@nhs.net",{"facility":343,"status":60,"city":295,"state":27,"zip":27,"country":79,"countryCode":80,"cosmosGeoPoint":344,"geoPoint":346,"contacts":347},"Royal London Hospital",{"type":65,"coordinates":345},[298,299],{"lat":299,"lon":298},[348],{"name":349,"role":51,"phone":27,"phoneExt":27,"email":350},"Nandiran Ratnavel","Nandiran.Ratnavel@nhs.net",{"facility":352,"status":60,"city":295,"state":27,"zip":27,"country":79,"countryCode":80,"cosmosGeoPoint":353,"geoPoint":355,"contacts":356},"St Thomas Hospital",{"type":65,"coordinates":354},[298,299],{"lat":299,"lon":298},[357],{"name":358,"role":51,"phone":27,"phoneExt":27,"email":359},"Suresh Victor","suresh.victor@kcl.ac.uk",{"facility":361,"status":60,"city":295,"state":27,"zip":27,"country":79,"countryCode":80,"cosmosGeoPoint":362,"geoPoint":364,"contacts":365},"Whipps 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Yates","01903205111","edward.yates@nhs.net",{"type":515,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100507601","phase-3-cooling-in-mild-encephalopathy-100507601",false,"NCT05889507","Cooling in Mild Encephalopathy","Whole-body Hypothermia Versus Normothermia in Mild Neonatal Encephalopathy: A Multicentre Randomised Controlled Trial","COMET","Inclusion Criteria:\n\nAll babies born at or after 36 weeks of gestation with a birth weight of 1800g or more with birth acidosis or requiring resuscitation at birth will be screened for eligibility.\n\nParents will be approached for consent if the baby meets all the three (A + B + C) criteria below:\n\nA. Evidence of intra-partum hypoxia-ischemia defined as any of - (i) Apgar score of \\\u003C6 at 10 minutes after birth; (ii) continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth; (iii) severe birth acidosis defined as any occurrence of pH =\\\u003C7.00 or a Base deficit \\>=16mmol\u002Fl in any cord or baby gas sample within 60 minutes of birth.\n\nB. Evidence of mild hypoxic ischaemic encephalopathy defined as - two or more abnormal findings in any of the six categories of the modified Sarnat examination (level of consciousness, spontaneous activity, posture, tone, primitive reflexes, and autonomic nervous system) but not meeting the diagnosis of moderate or severe hypoxic ischaemic encephalopathy on a standardised examination performed by a certified examiner between 1 to 6 hours of age.\n\nC. Normal amplitude on aEEG performed for at least 30 minutes between 1 to 6 hours of age. Normal amplitude will be defined as upper margin of the aEEG activity more than 10 microvolts and the lower margin more than 5 microvolts on a single channel aEEG.\n\nExclusion Criteria:\n\n* Infants who meet the BAPM criteria for whole-body hypothermia\n* Infants without encephalopathy defined as less than two abnormalities on structured neurological examination.\n* Infants with major congenital or chromosomal anomalies identified prior to randomisation.\n* Infants with birthweight \\\u003C1800g.\n* Infants who have already received sedation, muscle relaxation, or anti-convulsants prior to neurological assessment.","ALL","1 Hour","6 Hours",{"count":528,"type":529},426,"ESTIMATED","INTERVENTIONAL",[532],"PHASE3","The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish uniform practice across the NHS.\n\nThe main questions it aims to answer are:\n\n1. Does whole-body cooling (33.5±0.5°C) initiated within six hours of birth and continued for 72 hours, improve cognitive development at 24 (±2) months of age after mild neonatal encephalopathy compared with normothermia (37±0.5°C)?\n2. Does a prospective trial-based economic evaluation support the provision of cooling therapy for mild encephalopathy in the NHS on cost-effectiveness grounds?\n\nParticipants will have the following interventions:\n\n* Randomisation into one of the following groups\n\n  * Whole body hypothermia group\n  * Targeted normothermia group\n* Bayley Scales of Infant and Toddler Development 4th Edition (Bayley-IV) examination at 24 (±2) months of age.\n\nResearchers will compare the mean Cognitive Composite Scale score from the Bayley IV examination between the two groups.",[535,536],"Neonatal Encephalopathy","Newborn Asphyxia",[538],"therapeutic hypothermia","2026-02-04",{"date":541,"type":542},"2026-02-06","ACTUAL",{"date":544,"type":542},"2024-03-15",{"date":546,"type":529},"2030-01-01",{"name":5,"class":6},39]