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New treatment option for Hypoxic Ischemic Encephalopathy (HIE)
Official title Caffeine for Hypoxic Ischemic Encephalopathy
ClinicalTrials.gov ID: NCT06855108
What this study is testing
What is Caffeine citrate oral solution?
Caffeine citrate oral solution is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hypoxic ischemic encephalopathy (hie).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 6
You may be able to join if
- Participant Infants who meet all the following criteria are eligible for enrollment as study participants:
- 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...
You likely can't join if
- Infants who meet any of the following criteria are not eligible for enrollment as study participants:
- Home births
- Infants who cannot be enrolled, assigned by chance 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...
- Infant has received therapeutic hypothermia or there is a clinical plan to initiate active or passive hypothermia for the infant.
See the full eligibility criteria
- Participant Infants who meet all the following criteria are eligible for enrollment as study participants:
- 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:
- pH \<7.0; or
- Base Deficit ≥16 mmol/L; or
- Lactate \>8 mmol/L.
- 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...
- 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
- 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
- A clinical diagnosis of seizure in the first six hours after birth. Participant
- Infants who meet any of the following criteria are not eligible for enrollment as study participants:
- Home births
- Infants who cannot be enrolled, assigned by chance 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.
- Enrollment in another trial that will impact participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Saidpur, Bangladesh
- Kinshasa, Democratic Republic of the Congo
- Chimaltenango, Guatemala
- Belagavi, India
- Nagpur, India
- Karachi, Pakistan
- Lusaka, Zambia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 6 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saidpur, Bangladesh; Kinshasa, Democratic Republic of the Congo; Chimaltenango, Guatemala; Belagavi, India; Nagpur, India; Karachi, Pakistan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.