Phase 1
N=4
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
Hypoxic Ischemic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT00620711 ↗Enrolled (actual)
4
Serious AEs
50.0%
Results posted
Jul 2014
Primary outcome: Primary: Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature. — 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Olympic Cool Cap (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature. |
2 | — |
| PRIMARY Cap Cooled to 12 Degrees Without Reducing Rectal Temperature |
2 | — |
Summary
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
Eligibility Criteria
Inclusion Criteria
- Babies 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
Data sourced from ClinicalTrials.gov (NCT00620711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.