Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Infectious Disease, Neurology, Psychiatric |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/31/2019 |
| Start Date: | February 2008 |
| End Date: | July 2013 |
IRB# 070984 "Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy"
The hypothesis is that premature infants' can have enough cooling applied to cool their brain
to decrease CNS injury without cooling their body.
to decrease CNS injury without cooling their body.
Hypoxic ischemic encephalopathy (HIE) is a potentially devastating disease of the newborn
central nervous system (CNS) . Portions of the CNS are deprived of oxygen and blood flow for
a period of time which may lead to permanent brain injury manifested as cerebral palsy as
well as cognitive defects. Until recently no treatment has been shown to be effective for
preventing brain damage, even though it has been demonstrated that the damage is progressive
and that there is a window of opportunity to arrest some of the evolving brain injury.
However, in May of 2007 the FDA approved the first device specifically designed to ameliorate
brain damage in term babies with HIE. This head cooling device which was studied here at
Vanderbilt under IRB protocol 990129 Brain Cooling for the treatment of perinatal hypoxic
ischemic encephalopathy. We thus have eight years of experience of using this device in term
infants. The results of the initial trial demonstrated a successful reduction of HIE induced
brain injury from 66% in control infants to 55% in treated babies. There were no significant
risks to the application of this device in term babies who are kept cool for 72 hours after
experiencing an acute HIE event. The initial trials were limited to term babies because of
concern that premature infants would be more at risk for hypothermia induced problems such as
hypoglycemia,and coagulopathy. The concern about hypothermia in preterm infants remains a
limiting consideration for doing whole body cooling in this population. We propose to apply
the cooling cap to the heads of preterm infants who have experienced a significant HIE injury
but maintain their body temperature in the normal range (36.1-37° C rectally). Infants will
be cooled for up to 72 hours and will be tracked till discharge. Although this is a
feasibility study, the participants will also be followed-up at 6, 12 and 24 months of age.
central nervous system (CNS) . Portions of the CNS are deprived of oxygen and blood flow for
a period of time which may lead to permanent brain injury manifested as cerebral palsy as
well as cognitive defects. Until recently no treatment has been shown to be effective for
preventing brain damage, even though it has been demonstrated that the damage is progressive
and that there is a window of opportunity to arrest some of the evolving brain injury.
However, in May of 2007 the FDA approved the first device specifically designed to ameliorate
brain damage in term babies with HIE. This head cooling device which was studied here at
Vanderbilt under IRB protocol 990129 Brain Cooling for the treatment of perinatal hypoxic
ischemic encephalopathy. We thus have eight years of experience of using this device in term
infants. The results of the initial trial demonstrated a successful reduction of HIE induced
brain injury from 66% in control infants to 55% in treated babies. There were no significant
risks to the application of this device in term babies who are kept cool for 72 hours after
experiencing an acute HIE event. The initial trials were limited to term babies because of
concern that premature infants would be more at risk for hypothermia induced problems such as
hypoglycemia,and coagulopathy. The concern about hypothermia in preterm infants remains a
limiting consideration for doing whole body cooling in this population. We propose to apply
the cooling cap to the heads of preterm infants who have experienced a significant HIE injury
but maintain their body temperature in the normal range (36.1-37° C rectally). Infants will
be cooled for up to 72 hours and will be tracked till discharge. Although this is a
feasibility study, the participants will also be followed-up at 6, 12 and 24 months of age.
Inclusion Criteria:
- Babies < 36 weeks gestation but > 32 0/7 weeks. These babies should be small enough to
allow brain cooling with water circulating in a cooling cap applied to the surface of
their head
- At least one of the following four criteria which are standard definitions for HIE:
- Apgar 0-3 at 1,5,10 minutes due to hypoxia
- pH less than 7.0
- Base deficit greater than 15
- Need for continued resuscitation due to hypoxia at 10 minutes
- AND a physical exam with evidence of hypotonia or lethargy or seizures indicative of
evolving HIE.
- Intubated
- Age less than 6 hours
- Signed informed consent by parent / legal guardian
- Previous participant has been followed through 7 day head ultrasound.
Exclusion Criteria:
- Mild HIE will not be cooled, therefore babies without hypotonia or lethargy and babies
who are not intubated will be excluded.
- Gestational age ≥ 36 weeks or < 32 weeks or less than 1200 grams.
- Older than 6 hours of age
- Infant deemed in extremis on clinical exam.
- Survival not expected, i.e. received 3 intravenous doses of epinephrine or more during
resuscitation; on infusion of dopamine, dobutamine and/or epinephrine at time of
evaluation; and/or has fixed/dilated pupils.
- Evidence of head trauma or skull fracture causing major intracranial hemorrhage
- Intraventricular hemorrhage
- Weight less than the 5th percentile for gestational age
- Refusal of consent
- Imperforate anus
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