Caffeine for Hypoxic-Ischemic Encephalopathy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2024-12-31

Brief Summary

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Hypoxic-ischemic encephalopathy (HIE) due to perinatal asphyxia is common and often fatal. Therapeutic hypothermia reduces mortality and morbidity in infants with HIE. Even with the widespread use of therapeutic hypothermia, \~60% of infants with HIE die or have neurodevelopmental impairment. As a result, there is an urgent, unmet public health need to develop adjuvant therapies to improve survival and neurodevelopmental outcomes in this population.

Caffeine may offer neuroprotection for infants with HIE by blocking adenosine receptors in the brain and reducing neuronal cell death. In animal models of HIE, caffeine reduces white matter brain injury. Drugs in the same class as caffeine (i.e., methylxanthines) have been shown to be protective against acute kidney injury in the setting of HIE. However, their safety and efficacy have not been studied in the setting of therapeutic hypothermia and their effect on neurological outcomes is not known. Since these drugs reduce injury to the kidney in infants with HIE, they may also reduce injury to the brain.

This phase I study will evaluate the pharmacokinetics, safety, and preliminary effectiveness of caffeine as an adjuvant therapy to improve neurodevelopmental outcomes in infants with HIE.

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Detailed Description

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Conditions

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Hypoxic-Ischemic Encephalopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The first cohort of 9 infants will receive a lower maintenance dose of caffeine. Following a safety review, an additional 9 infants will receive a higher maintenance dose.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Dose Caffeine (5 mg/kg)

Within 24 hours of delivery, participants will receive low dose administration of Caffeine citrate.

Group Type ACTIVE_COMPARATOR

Caffeine Citrate 5 mg/kg

Intervention Type DRUG

Loading dose of caffeine 20 mg/kg IV followed by two daily doses of 5 mg/kg IV.

High Dose Caffeine (10 mg/kg)

Within 24 hours of delivery, participants will receive high dose administration of Caffeine citrate.

Group Type ACTIVE_COMPARATOR

Caffeine Citrate 10 mg/kg

Intervention Type DRUG

Loading dose of caffeine 20 mg/kg IV followed by two daily doses of 10 mg/kg IV.

Interventions

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Caffeine Citrate 5 mg/kg

Loading dose of caffeine 20 mg/kg IV followed by two daily doses of 5 mg/kg IV.

Intervention Type DRUG

Caffeine Citrate 10 mg/kg

Loading dose of caffeine 20 mg/kg IV followed by two daily doses of 10 mg/kg IV.

Intervention Type DRUG

Other Intervention Names

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Cafcit Cafcit

Eligibility Criteria

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Inclusion Criteria

* Documented informed consent from parent or guardian
* ≥ 36 weeks gestational age at birth
* Receiving therapeutic hypothermia for a diagnosis of HIE
* Intravenous (IV) access
* Postnatal age \< 24 hours

Exclusion Criteria

* Receiving \> 1 anti-epileptic drug for seizures
* Sustained (\>4 hours) heart rate \> 180 beats per minute
* Known major congenital anomaly
* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No