Cooling in Mild Encephalopathy

Launched by IMPERIAL COLLEGE LONDON · May 25, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Cooling in Mild Encephalopathy," is studying whether cooling treatment can help newborns who have mild brain injury due to lack of oxygen during birth. The researchers want to know if cooling the whole body to a lower temperature can improve a baby's brain development by the time they reach about two years old compared to babies who are kept at a normal temperature. They will also look at whether this treatment is cost-effective for the NHS, meaning whether it’s worth the money spent on it for the potential benefits it provides.

To be part of the study, babies need to be born at least 36 weeks into the pregnancy and weigh more than 1800 grams. They should show signs of needing help at birth, such as a low Apgar score or requiring resuscitation, and have mild signs of brain injury but not severe ones. If eligible, babies will be randomly assigned to either receive the cooling treatment or to be kept at a normal temperature. Researchers will check how well the babies develop at around two years old using a standard test. This trial is not yet recruiting participants, but it aims to provide important information for future treatments and guidelines for newborn care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All 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.
• Parents will be approached for consent if the baby meets all the three (A + B + C) criteria below:
• • A. Evidence of intra-partum hypoxia-ischemia defined as any of - (i) Apgar score of \<6 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 =\<7.00 or a Base deficit \>=16mmol/l in any cord or baby gas sample within 60 minutes of birth.
• • B. 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.
• • C. 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.
• Exclusion Criteria:
• • Infants who meet the BAPM criteria for whole-body hypothermia
• • Infants without encephalopathy defined as less than two abnormalities on structured neurological examination.
• • Infants with major congenital or chromosomal anomalies identified prior to randomisation.
• • Infants with birthweight \<1800g.
• • Infants who have already received sedation, muscle relaxation, or anti-convulsants prior to neurological assessment.