Caffeine for Hypoxic Ischemic Encephalopathy (NCT06855108) | Clinical Trial Compass
RecruitingPhase 3
Caffeine for Hypoxic Ischemic Encephalopathy
Bangladesh, Democratic Republic of the Congo, Guatemala830 participantsStarted 2026-04-08
Plain-language 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.
Who can participate
Age range
6 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Liveborn infants ≥36 weeks
. Birth weight ≥1800 grams
. Meets physiologic criteria for moderate to severe HIE, defined as meeting either of the following two criteria:
. Criterion #1: Severe acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria:
. Criterion #2: Participant must meet all of the following three criteria:
. 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:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite outcome, defined by the occurrence of any of the following:
Timeframe: 18-22 months
Trial details
NCT IDNCT06855108
SponsorNICHD Global Network for Women's and Children's Health
. A clinical diagnosis of seizure in the first six hours after birth.
Exclusion criteria
. Home births
. Infants who cannot be enrolled, randomized and receive study medication within 6 hours post-delivery
. Infants with a recognized major congenital anomaly or genetic syndrome that would affect their neurodevelopment.
. 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.
. Infant has received therapeutic hypothermia or there is a clinical plan to initiate active or passive hypothermia for the infant.
. Infants who will be unavailable to complete follow-up visits.
. Infants who have received caffeine after delivery.
. Infants whom the health care team deem ineligible for the study based on likelihood to receive caffeine outside of the study protocol.