[Brenda Strohm:] I'm going to meet a family whose son, Thomas,
had a condition called perinatal asphyxia,
or lack of oxygen at birth.
He was quite a sick baby
and he was then randomised, by a computer selection,
to have a cooling treatment.
[Denis Azzopardi:] Sadly, even with best obstetric care, about 1 or 2 in every 1,000 births...
suffer from lack of oxygen around the time of birth.
[Thomas' father:] When we were told about the news it was quite devastating.
At that stage it was a bit of a no-brainer.
We were absolutely all in for going ahead with the trial.
[Thomas:] "I was in the cold box and I couldn't breathe when I came out of your tummy."
[Brenda Strohm:] Lots of people are aware of anecdotal stories of near drownings in cold water
or recovery from exposure in cold situations.
Start off slowly, start off small
and gradually reach the point where you've got enough evidence to
support running a larger project
to try and produce evidence.
[Denis Azzopardi:] The TOBY study was a randomised trial
where half the babies were treated with standard care
and the other half were treated with standard care plus cooling
by about 3 degrees below the normal temperature.
The National Perinatal Epidemiology Unit is a coordinating centre
and Brenda Strohm was the trial coordinator.
They ensured that all the hospitals were properly trained up
and there was a central repository for all the study data, to analyse the data.
[Brenda Strohm:] During the birth process, or shortly before birth,
for some reason, the baby is not getting the oxygen that it requires.
[Denis Azzopardi:] You need to start treatment as early as possible
to prevent any injury happening to the brain.
So we start within six hours of birth,
after giving enough time for the parents to understand what is going to be done to the baby.
Then we get the temperature down to about 3.5 degrees Celsius and keep it there for 72 hours,
hopefully allowing time for all the inflammation and other harmful processes to settle down.
Then we slowly rewarm the baby up over about 12 hours.
All metabolic processes -- all the processes that require energy --
are suppressed by cooling,
so cooling reduces the energy demand of the brain.
We know that this then suppresses the inflammatory response,
the burst of inflammation and other harmful processes
that occur when you've suffered a lack of oxygen.
It's something akin to when you have an injury to a joint --
you put something cold over it to suppress the swelling and inflammation.
[Brenda Strohm:] "Thomas, can I shake your hand?
Lovely to meet you, really lovely to meet you."
"Clearly you were aware that Thomas was poorly when he was born,
so can you remember what it was like
when you were told about his condition
and the idea of the trial was introduced to you?"
[Thmoas' mother:] I was absolutely devastated when they told me about his condition.
Then, at the same time, they did talk about the trial
but I couldn't take a lot of information in,
I was in a bit of a meltdown place.
[Denis Azzopardi:] So one of the hardest things about doing things like this
is that you have to provide a lot of information about the study to the parents
at a time when they are very stressed
-- the mother's just delivered a baby
and has just received the news that the baby's very sick.
Therefore, it's very important to try and give the parents time to understand what is happening,
and what we are suggesting.
[Brenda Strohm] '...realised how poorly Thomas was and when the trial was introduced to you?"
[Thomas' father:] "When we were told about the news it was quite devastating,
but my immediate reaction was: what are the side effects?
And we were told that there weren't any possible side effects.
The other issue was, would he be cooled or not?
And we were in the hands of the random number to see if he was selected or not."
[Denis Azzopardi:] The TOBY study was the largest of a number of randomized controlled trials
that explored this therapy.
In fact, when we did them, the summary analyses of all the clinical trials
confirmed that treatment with cooling reduces the chances of dying
or developing cerebral palsy by about 50%.
In the context of the UK, we can predict that about 100 more babies,
every year,
are surviving without cerebral palsy as a result of this treatment.
[Brenda Strohm] "(to Thomas:)...it doesn't need batteries,
so if you squeeze it, that's how you recharge it..."
So you're probably aware that NICE recommended cooling as standard treatment since 2010 actually.
So how does that make you feel?
[Thomas' mother:] I think it's absolutely fantastic, absolutely fabulous.
If there's anything that you can do for a baby that has had some injury when they're born,
then that is just brilliant.
[Brenda Strohm:] "Bye bye..."
It's very rewarding to come and actually see the evidence of a baby
who started off with lots of difficulties
and has clearly done very well and continued to stay well and healthy.
Because not all of them do,
but Thomas is certainly a perfect example.