>> I think that most physicians who remember their first encounter in the NICU with a critically
low birth weight premature infant, they're fascinatingly resilient.
At the same time, they present a real clinical conundrum.
Just looking at them, it is immediately clear that they shouldn't be here yet; they're not
ready.
>> The first health challenge the very preterm babies face is actually surviving, being born
very preterm.
Amongst those that survive, the challenges really are some of the things we all take
very much for granted: walking, talking, seeing, hearing, and developing along the normal path.
>> Many of the infants that are born preterm once they leave the hospital can be institutionalized.
Many of the infants have cerebral palsy.
>> In the United States, about 1 percent of all infants are considered significantly premature.
And so, the frequency of prematurity has increased significantly in the last two or three decades.
So, the problem isn't going away.
>> So, some of the terms we use when talking about preterm infants is mortality, which
means death, and morbidity, which means sickness.
So, if we take a look at mortality of the infants born at 24 weeks, it's around about
50 percent.
Now, those infants that do survive the early neonatal period, they are normally around
about 90 percent morbidity.
So the majority of those infants born at 24 weeks have some sort of illness, and most
of the time that is due to lung immaturity.
>> When babies are born at 23 and 24 weeks, they're really not ready to breathe.
They are being cared for with tools that are the best we can provide, and they provide
a great benefit compared to 50 years ago.
But compared to where we would like to be, we're still not close.
>> Our system is really a recreation of the environment that a fetus normally resides in.
>> So, many research groups have been trying to develop a system like this since the 1950s;
however, they've met with limited success.
So, we went back to the literature, and we had a look at what other people had tried,
and we sort of transitioned our line of thought to let's not treat this as a newborn baby,
let's actually treat this as a fetus.
>> We chose the lamb, an animal model for a number of reasons.
Most of what we know about human fetal development is from the lamb.
So, all of the physiologic research over the past 50, 60 years that have told us about
the fetal circulation, about developmental events, most of it has been from the lamb.
The system — it works by two major components.
The first one is a circulatory system that goes through an oxygenator.
So, it's a connection through the umbilical cord vessels that allows blood to flow out
of the fetus through the oxygenator back into the fetus.
It exchanges gas like the placenta does.
And then the other component is a fluid environment that surrounds the fetus and allows the fetus
to swallow and breathe amniotic fluid like it's supposed to during development.
Our lambs receive everything that they receive in their mothers' womb in a very physiologic way.
So, they mature normally; they grow normally.
>> We have reported in our manuscript the support of these fetuses for up to four weeks,
which is far in excess of the experience of other researchers.
>> So, Thomas Edison said to be an inventor, all you need is an imagination and a pile
of junk.
And essentially, that is the story of this system.
>> For the first few generations, we used a lot of supplies from plumbing/piping, beer
stores.
We did not have grants at the time.
So, it really required a bit of innovation to create the first prototype really from
nothing.
>> And so, they gathered up some used items from the ECMO program and went on eBay and
Home Depot and came up with a primitive fishbowl system.
And with all of that, I was convinced that we could do some pilot experiments and they
worked amazingly well.
>> One thing the project has taught me is never give up.
You've got to keep going, keep going until it works.
>> We believe that the animal data that we have reported in this manuscript really supports
translating our system into a clinical therapy for human babies.
>> In the future, we envision a system that will be in the NICU, and it will look pretty
much like a traditional incubator.
It will have a lid that we'll be able to move up and down, and inside that heated warm chamber
will be the infant.
>> It is a hugely important point that we do not intend to challenge the currently accepted
standard for a viable infant.
The challenging age that we're trying to offset is that 23- to 24-week baby who is faced with
such a challenge of adapting to life outside of the uterus on dry land.
So, our intention would not be to support them on our system until they were a chubby
40-week gestation babe.
The idea is to bridge the rough patch when they're really struggling and carry them through
to a point when they can do OK.
>> Nobody is looking to extend the limits of viability with this set of care techniques.
I think we're just simply trying to provide a different set, a different model that has
... is clearly revolutionary.
>> If it's as successful as we think it can be, ultimately, the majority of pregnancies
that are predicted at a risk for extreme prematurity would be delivered early onto our system,
rather than being delivered premature onto a ventilator.
With that, we would have normal physiologic development and avoid essentially all of the
major risks of prematurity.
And that would translate into, you know, a huge impact on pediatric health.
We're in the process of interacting with the FDA.
So, it's not inconceivable that, you know, we could be talking about a clinical trial
one to two years from now.
>> It never fails to strike me what a miracle it is to see this fetus that is clearly not
ready to be born enclosed in this fluid space — breathing, swallowing, swimming, dreaming —
with complete detachment from the placenta and from mom.
It is an awe-inspiring sight.
This certainly is a project that would have sounded more like science fiction than a reality,
but over three years of really doggedly pursuing it and refusing to accept setbacks and limitations,
it has become a very real therapeutic tool.
>> We had this kind of sort of cool group of people where we could really approach this
from different angles and apply all of our skill sets together to move forward and succeed.
>> It has been nothing but a privilege to do this work because of the potential that
it represents.
These infants are desperate for solutions and for innovation.