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โ† Trials
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Caffeine for Hypoxic Ischemic Encephalopathy

RecruitingPhase 3Ages any - 6 HoursAllNICHD Global Network for Women's and Children's Hโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 HI

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Participant Inclusion Criteria: Infants who meet all the following criteria are eligible for enrollment as study participants: 1. Liveborn infants โ‰ฅ36 weeks 2. Birth weight โ‰ฅ1800 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 โ‰ฅ16 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 โ‰ฅ10 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.
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What it tests

  • Caffeine citrate oral solution
  • Oral placebo solution
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Where

7 sites
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
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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