Dose Optimization of Caffeine for HIE

University of North Carolina (UNC)

Status and phase: Enrolling; Phase 1

Conditions: Hypoxic-Ischemic Encephalopathy

Treatments: Drug: Caffeine citrate 30 mg/kg; Drug: Caffeine citrate 20 mg/kg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06448780

1K23HD111623-01 (U.S. NIH Grant/Contract)

24-0654

Details and patient eligibility

About

This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.

Full description

In a previous phase I trial (NCT03913221), the investigators characterized the pharmacokinetics (PK) of caffeine in the setting of HIE and therapeutic hypothermia using a population PK model. This is an open-label study of caffeine citrate in neonates with HIE to validate the population PK model and determine optimal dosing for HIE.

Enrollment: 16 estimated patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Lower loading dose (20 mg/kg)

Active Comparator group

Description:

Within 24 hours after delivery, participants will receive a loading dose of 20 mg/kg caffeine citrate IV.

Treatment:

Drug: Caffeine citrate 20 mg/kg

Higher loading dose (30 mg/kg)

Active Comparator group

Description:

Within 24 hours after delivery, participants will receive a loading dose of 30 mg/kg caffeine citrate IV.

Treatment:

Drug: Caffeine citrate 30 mg/kg