Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy.
Recruitment to TOBY ended on 30th November 2006.
18 month Follow up was completed in autumn 2008.
1st October 2009
The TOBY Study results have now been published in the New England Journal of Medicine:
Moderate Hypothermia to Treat Perinatal Asphyxial Encephalopathy; Azzopardi D, Strohm B, Edwards A, Dyet L, Halliday H, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; N Engl J Med, 2009; 361:1349-1358.
This landmark randomised controlled trial was funded during the period 2002 to 2008, by the United Kingdom Medical Research Council (MRC). The MRC is also funding the TOBY Children Study over the next 4 years, which will follow up TOBY children at the age when they have started school.
The TOBY Children Study
TOBY children will be assessed at age 6 - 7 years, in order to find out whether the benefits of cooling that were apparent at 18 months are maintained in the longer term.
Perinatal asphyxia causing moderate or severe encephalopathy occurs in approximately 2/1000 births. In full term newborn infants, perinatal asphyxia may account for up to 30% of cases of cerebral palsy, and results in a significant health care and financial burden to the NHS. At present there is no specific treatment for asphyxia other than stabilisation with treatment to reduce seizures.
This study aims to determine whether the use of whole body cooling following perinatal asphyxia is a safe treatment that will improve survival and reduce neurological and neurodevelopmental impairments. Babies who have experienced moderate or severe asphyxia are randomly allocated to receive either standard intensive care, or intensive care with cooling.
Randomisation must take place before the baby is 6 hours of age, and the allocated treatment is commenced immediately. Cooled babies have their body temperature reduced to 33-34°C for 72 hours, followed by gradual rewarming.
Primary outcome is the combined rate of mortality and severe neurodevelopmental impairment in survivors at 18 months of age.
This randomised controlled trial is funded by the Medical Research Council.