Therapeutic hypothermia with intracorporeal temperature monitoring for hypoxic perinatal brain injury

Other comments from NICE

There are uncertainties and difficulties in deciding which newborn babies might benefit from this procedure. In particular, there is little evidence about whether to use it for babies with less severe brain injury and there are difficulties in deciding whether some babies are too ill to benefit from it.

What does this mean for me and my baby?

NICE has said that this procedure is safe enough and works well enough for use in the NHS. If your baby's doctor thinks controlled cooling is a suitable treatment option for your baby, he or she should still make sure you understand the benefits and risks before asking you to agree to it.

You may want to ask the questions below

How well does the procedure work?

One study looked at all the results from 10 separate studies with a total of 1320 babies. Across the 10 studies, the risk of death was lower in the babies who had cooling compared with babies who were treated by standard care. In 3 of the 10 studies (a total of 767 babies) the combined risk of death or severe disability was lower in babies who had cooling compared with those who did not, and babies who were cooled were more likely to have survived without brain damage after 18 months. In the babies who survived, the risks of severe disability or cerebral palsy were higher in infants treated with standard care compared to those who were treated with cooling.

A study of 325 babies reported that 71 out of 163 babies who had cooling and 45 out of 162 babies who had standard care survived without brain damage. Of the babies who survived, fewer of those who were treated with cooling had cerebral palsy (33 out of 120) compared with those who had standard care (48 out of 117).

In a study of 234 babies, 59 out of 108 babies treated with head cooling were reported to have severe disabilities or to have died after 18 months, compared with 73 out of 110 babies treated with standard care.

As well as looking at these studies, NICE also asked expert advisers for their views. These advisers are clinical specialists in this field of medicine. The advisers said that the success of the procedure can be assessed by survival without brain damage, less severe disability, lower rates of cerebral palsy and better scores in developmental tests.

Risks and possible problems

In a study of 234 babies, 1 baby had skin problems and bleeding under the cooling cap. There were also 2 separately reported instances of a baby developing skin problems where the cooling materials (ice packs or a cooling mattress) were in contact with the skin.

As well as looking at these studies, NICE also asked expert advisers for their views. These advisers are clinical specialists in this field of medicine. The advisers said that possible complications include problems with metabolism (the chemical processes in the body), problems caused by thickened blood, infections, and fits which can sometimes occur if the baby is warmed up too quickly after treatment.