RecruitingPhase 4NCT06518603

Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

Randomized Controlled Trial of Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia


Sponsor

University of Alabama at Birmingham

Enrollment

340 participants

Start Date

Jun 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 0 DaysMax Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Caffeine citrate 20mg/kg/day and a drug called Placebo-Sterile water 1ml/kg/day for people with apnea of prematurity, development, infant, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCaffeine citrate 20mg/kg/day

Caffeine citrate 20mg/kg/day given orally once daily for 28 days

DRUGPlacebo-Sterile water 1ml/kg/day

Placebo-sterile water 1mg/kg/day given orally once daily for 28 days


Locations(1)

University Teaching Hospital

Lusaka, Lusaka Province, Zambia

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NCT06518603


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