Could caffeine help save newborn brains? major trial launches

NCT ID NCT06855108

Recruiting now Disease control Sponsor: NICHD Global Network for Women's and Children's Health Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving caffeine to newborns with hypoxic ischemic encephalopathy (HIE) can reduce death or long-term disability. HIE is a brain injury caused by lack of oxygen around birth. The trial will enroll 830 full-term infants and give them either caffeine or a placebo within six hours of birth. Researchers will follow the children until 18-22 months of age to compare outcomes.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: caffeine citrate oral solution
What this could lead to: If it works, this could provide a simple, low-cost treatment to lower the risk of death or long-term disability in newborns with HIE.
What could go wrong: This is an early-stage trial, and caffeine may not improve outcomes. The study is still recruiting, so results are years away.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HYPOXIC-ISCHEMIC ENCEPHALOPATHY (HIE)

Contacts and locations

Locations

Aga Khan University
NOT_YET_RECRUITING

Karachi, Pakistan
ICDDR,B
RECRUITING

Saidpur, Bangladesh
Institute of Nutrition of Central America And Panama (INCAP)
RECRUITING

Chimaltenango, Guatemala
KLE University's J N Medical College
NOT_YET_RECRUITING

Belagavi, India
Kinshasa School of Public Health
NOT_YET_RECRUITING

Kinshasa, Democratic Republic of the Congo
Lata Medical Research Foundation
NOT_YET_RECRUITING

Nagpur, India
University Teaching Hospital
RECRUITING

Lusaka, Zambia

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