Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Premature Infant Disease, Apnea of Prematurity, Development, Infant

In brief

The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age. Our research questions are: 1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits? 2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age? Researchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits. Parents of participants will: 1. Administer caffeine citrate 20mg/kg/day or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge 2. Keep a diary of symptoms and any apneic events 3. Check in with researchers via telephone call once a week 4. Return to clinic for infant physical examination at 28 days 5. Return to the clinic for infant physical examination at 2 months 5\. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age

Key facts

Study ID

NCT06518603

Run by

University of Alabama at Birmingham

People needed

340

Starts

2026-06-17

Expected to finish

2027-06-30

Last updated by the study team

2026-06-23

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newborns:
• 29 0/7 to 33 6/7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU,
• On methylxanthines with plans to discontinue on methylxanthine,
• Off oxygen therapy for >48 hours at the time of evaluation for eligibility,
• Receiving full daily feeds,
• Deemed stable and ready to go off caffeine as recommended by the Neonatologist
• 18+ years of age (parent)

You may not qualify if…

• Newborns with neuromuscular conditions affecting respiration,
• Major congenital malformations and genetic disorders,
• Unable to obtain parental or guardian consent

Where it is running

• University Teaching Hospital — Lusaka, Lusaka Province, Zambia (enrolling)

Full record on ClinicalTrials.gov

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