The TOBY Children Study (Follow up at school age)

Outcome at School Age Following Treatment With Whole Body Hypothermia After Perinatal Asphyxial Encephalopathy.

Trial started: 2009  Trial ended: 2013 

Summary

Objectives

To determine whether the benefits of moderate hypothermia after perinatal asphyxia extend to neurocognitive and neurological outcomes at 6–7 years of age.

Methods

A follow-up of children from the Total Body Hypothermia for Neonatal Encephalopathy (TOBY) randomised controlled trial. In the original trial, 325 newborns with asphyxial encephalopathy born at ?36 weeks' gestation were randomised to receive either standard care alone or standard care with whole-body cooling to 33–34°C for 72 hours, started within 6 hours of birth. Neurocognitive and neurological outcomes were assessed at 6–7 years of age.

Outcome measures

Primary outcome: Survival with an IQ score of ?85 at 6–7 years of age.

Other outcomes included death, survival without neurological abnormalities, cerebral palsy, moderate or severe disability, motor function, health status and psychometric assessments.

Results

At 6–7 years, 75 of 145 (52%) children in the hypothermia group survived with an IQ score of ?85 compared with 52 of 132 (39%) in the control group (relative risk 1.31; p = 0.04). Mortality was similar between the hypothermia and control groups (29% vs 30%). More children in the hypothermia group survived without neurological abnormalities [65 of 145 (45%) vs 37 of 132 (28%); relative risk 1.60, 95% confidence interval 1.15 to 2.22]. Among survivors, cerebral palsy was less frequent in the hypothermia group (21% vs 36%; p = 0.03), as was moderate or severe disability (22% vs 37%; p = 0.03), and motor-function scores were better. There were no significant differences between groups in parental assessments of children's health status or in 10 of 11 psychometric tests.

Conclusions

Moderate hypothermia after perinatal asphyxia resulted in improved neurocognitive outcomes at 6–7 years of age.

Summary based on: Azzopardi D, Strohm B, Marlow N, et al. Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes. New England Journal of Medicine. 2014;371(2):140–149. https://doi.org/10.1056/NEJMoa1315788