Cooling therapy could improve health of newborns
On 1st October 2009, The TOBY Study results were published in the New England Journal of Medicine. This landmark randomised controlled trial was funded between 2002 and 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 Study looked at whether hypothermic (cooling) therapy improves neurodevelopmental outcomes in newborn infants who have suffered oxygen deprivation at or before birth.
A randomized trial of babies who were less than 6 hours of age, had a gestational age of at least 36 weeks and had suffered a lack of oxygen before birth were cooled in intensive care to temperatures of 33.5°
C for 72 hours. They were compared with babies with the same presentation who were cared for in intensive care alone. The primary outcome was death or severe disability at 18 months of age.
Of 325 babies trialled, 163 underwent intensive care with cooling, and 162 underwent intensive care alone. In the cooled group, 42 infants died and 32 survived but had severe disability, whereas in the noncooled group, 44 infants died and 42 had severe disability.
Infants in the cooled group had an increased likelihood of survival without any neurological abnormalities. Cooling resulted in reduced risks of cerebral palsy and improved scores on the Mental Developmental Index and Psychomotor Developmental Index of the Bayley Scales of Infant Development II and the Gross Motor Function Classification System. Improvements in other neurological outcomes in the cooled group were not significant.
So it can be concluded that induction of moderate hypothermia for 72 hours in infants who have experienced a lack of oxygen before or during birth did not significantly reduce the combined rate of death or severe disability but resulted in improved neurologic outcomes in survivors.