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NOT YET RECRUITING

NCT06855108

PHASE3

Caffeine for Hypoxic Ischemic Encephalopathy

Sponsor: NICHD Global Network for Women's and Children's Health

View on ClinicalTrials.gov

Summary

CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE). The trial will recruit neonates who are diagnosed with HIE within six hours after birth based on physiologic criteria (acidosis noted on an umbilical cord or early \[\<1 hour\] postnatal blood sample) and neurologic criteria (modified Sarnat exam consistent with encephalopathy). Following informed consent, and by six hours after birth, neonates with HIE will be randomized to one of two treatment arms and subsequently receive one 20 mg/kg dose of oral caffeine followed by two additional 10 mg/kg doses at 24-hour intervals or placebo of the same regimen (three total doses). The goal of this clinical trial is to compare the incidence of all-cause mortality OR moderate to severe neurodevelopmental impairment (NDI) at 18-22 months between neonates with HIE who are randomized to oral caffeine or placebo. Our hypothesis is that neonates with HIE who receive oral caffeine will have 10% lower incidence of all-cause mortality or moderate to severe NDI at 18-22 months compared to placebo.

Official title: Caffeine for Hypoxic Ischemic Encephalopathy (CHIME Trial)

Key Details

Gender

All

Age Range

Any - 6 Hours

Study Type

INTERVENTIONAL

Enrollment

830

Start Date

2025-06

Completion Date

2030-07

Last Updated

2025-03-03

Healthy Volunteers

Conditions

Hypoxic Ischemic Encephalopathy (HIE)

Interventions

DRUG

Caffeine citrate oral solution

Caffeine citrate oral solution will be used and administered by enteral route (oral or by gavage tube). The loading dose (20 mg/kg) will be administered once followed by daily doses of 10 mg per kg body weight every 24 hours for two doses. The study Standard Operating Procedures (SOPs) includes details regarding caffeine preparation based on the participant's body weight.

DRUG

Oral placebo solution

Identical placebo oral solution

Participant Inclusion Criteria: Infants who meet all the following criteria are eligible for enrollment as study participants: 1. Liveborn infants ≥36 weeks 2. Birth weight ≥1800 grams 3. Meets physiologic criteria for moderate to severe HIE, defined as meeting either of the following two criteria: 1. Criterion #1: Severe acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria: * pH \<7.0; or * Base Deficit ≥16 mmol/L; or * Lactate \>8 mmol/L. 2. Criterion #2: Participant must meet all of the following three criteria: i. Moderate acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria: * POC pH 7.0-7.15; or * Base Deficit 10.0-15.9 mmol/L; or * Lactate 6-8 mmol/L. ii. Evidence of an acute perinatal event (i.e., placental abruption, intrapartum hemorrhage, cord prolapse, severe fetal heart rate abnormality, uterine rupture). iii. Any of the following criteria: * 10-minute Apgar \<5; or * Need for assisted ventilation initiated at birth and continued for ≥10 minutes 4. Meets neurologic criteria for moderate to severe HIE, defined as a physical exam conducted between one and six hours after birth that meets either of the following criteria: 1. Moderate to severe encephalopathy in at least three out of six modified Sarnat categories (level of consciousness, spontaneous activity, muscle tone, posture, primitive reflexes, autonomic function); or 2. A clinical diagnosis of seizure in the first six hours after birth. Participant Exclusion Criteria: Infants who meet any of the following criteria are not eligible for enrollment as study participants: 1. Home births 2. Infants who cannot be enrolled, randomized and receive study medication within 6 hours post-delivery 3. Infants with a recognized major congenital anomaly or genetic syndrome that would affect their neurodevelopment. 4. Infants for whom medical care will not be provided based on the severity of their condition or any other condition that would preclude participation per clinical judgement. 5. Infant has received therapeutic hypothermia or there is a clinical plan to initiate active or passive hypothermia for the infant. 6. Infants who will be unavailable to complete follow-up visits. 7. Infants who have received caffeine after delivery. 8. Infants whom the health care team deem ineligible for the study based on likelihood to receive caffeine outside of the study protocol. 9. Enrollment in another trial that will impact participation in this trial.

Locations (7)

ICDDR,B

Saidpur, Bangladesh

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Institute of Nutrition of Central America And Panama (INCAP)

Chimaltenango, Guatemala

KLE University's J N Medical College

Belagavi, India

Lata Medical Research Foundation

Nagpur, India

Aga Khan University

Karachi, Pakistan

University Teaching Hospital

Lusaka, Zambia