NCT06855108: CHIME

Caffeine for Hypoxic Ischemic Encephalopathy (CHIME Trial)

Not yet recruiting Phase 3 Last updated 26 February 2025

What this trial tests

Phase 3 trial testing Caffeine citrate oral solution in Hypoxic Ischemic Encephalopathy (HIE) in 830 participants. Not yet recruiting.

Timeline

1 June 2025

Primary endpoint
1 December 2029

1 July 2030

Quick facts

Lead sponsor	NICHD Global Network for Women's and Children's Health
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	830
Start date	1 June 2025
Primary completion	1 December 2029
Estimated completion	1 July 2030
Sites	7 locations across Bangladesh, Democratic Republic of the Congo, Guatemala, India, Pakistan, Zambia

Drugs / interventions tested

• Caffeine citrate oral solution — full drug profile →
• Oral placebo solution

Conditions studied

• Hypoxic Ischemic Encephalopathy (HIE) — all drugs for Hypoxic Ischemic Encephalopathy (HIE) →

Sponsor

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

Who can join

Under 6 Hours, any sex, with Hypoxic Ischemic Encephalopathy (HIE). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Composite outcome, defined by the occurrence of any of the following:
  Time frame: 18-22 months
  All-cause infant mortality or moderate to severe neurodevelopmental impairment

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Necrotizing Enterocolitis: What's New and What's Next?
   Sha C, Sander WR, Bass K, Hsieh H, et al · · 2025 · cited 1× · PMID 41096926 · DOI 10.3390/ijms26199660