Caffeine for Hypoxic Ischemic Encephalopathy in Newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CHIME is a phase 3, randomized, double-blind, placebo-controlled study enrolling newborns with moderate to severe HIE within six hours of birth. Eligible infants are assigned to receive a total of three oral doses of caffeine citrate or placebo, starting with 20 mg/kg, then two 10 mg/kg doses at 24-hour intervals. The trial will compare all-cause mortality or moderate-to-severe neurodevelopmental impairment at 18–22 months between the caffeine and placebo groups. Primary safety and efficacy assessments include neurologic outcomes and organ function in the neonatal period and long-term neurodevelopment. The study is conducted through an international network with multiple collaborating sites and sponsors.

Why it matters

Who can join: the full rules

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.

Where it's running

• Icddr,b
  Saidpur, Bangladesh Recruiting
• Institute of Nutrition of Central America And Panama (INCAP)
  Chimaltenango, Guatemala Recruiting
• University Teaching Hospital
  Lusaka, Zambia Recruiting
• Kinshasa School of Public Health
  Kinshasa, Democratic Republic of the Congo Not yet recruiting
• KLE University's J N Medical College
  Belagavi, India Not yet recruiting
• Lata Medical Research Foundation
  Nagpur, India Not yet recruiting

Study contacts

• Principal investigator: Melissa Bauserman, MD, MPH — University of North Carolina, Chapel Hill
• Study coordinator: Laura Danielle Wagner, MPH
• Email: wagner@rti.org
• Phone: +1-919-541-6000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.