A Phase 4 interventional study of Caffeine citrate 20mg/kg/day and Placebo-Sterile water 1ml/kg/day in Premature Infant Disease, Apnea of Prematurity and Development, Infant, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in Zambia. Open to participants aged 0 Days to 12 Months. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Prevention
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:
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:
5. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age
Once an infant has been deemed stable by the neonatologist and the neonatologist recommends discontinuing treatment for apnea of prematurity 5 days before hospital discharge as per standard of care, the parent/guardian will be approached for consent. Following consent, study participants will be randomized to either the Intervention Arm (20mg/kg/day caffeine citrate; 2mg/ml) dose and equal volume of placebo (sterile water) using trial-specific single dose caffeine/placebo vials. Upon the study participant's hospital discharge, the pharmacist will prepare the caffeine citrate and placebo relevant to the weight of the infant within 48 hours prior to discharge. The doses will not be adjusted for weight gain after discharge. Caffeine levels will not be checked routinely and checking levels will be discouraged to optimize masking.
While at the hospital, infants will receive the oral dose from government staff. Following hospital discharge, the parent/guardian will be given enough doses of caffeine or equivalent placebo for 28 days and will be asked to administer it to their infant orally daily, at the same time, until day 28. Unlike the intervention arm, all study participants randomized to the control arm (placebo) will discontinue receiving caffeine and will begin receiving placebo (sterile water) in the same volume orally as those in the intervention arm. The parent/guardian will also be given a booklet to register any apneic spells. The study RA will contact the parent/guardian on a weekly basis, up to day 28 and once at 2 months after hospital discharge for patient clinical monitoring and follow-up purposes.
Upon completion of the study at 12 months of life, all study participants will return to the hospital for neurodevelopmental screening using the Ages and Stages-3 Questionnaire for 12 months.
Data will be collected onto paper forms, which will then be entered into a REDCap Database, housed at the Centre for Infectious Disease Research in Zambia (CIDRZ) offices. Data forms will be kept in locked cabinets, retained and destroyed per incineration after 5 years. Access to the data forms and REDCap Database will be restricted to those with a need to know.
282 studies on the registry are indexed under Apnea; 54 are open to participants now.
This study's planned enrollment of 340 is above the median of 60 across 195 interventional studies indexed under Apnea.
Browse Apnea studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Newborns:
Exclusion Criteria:
Caffeine Citrate 20 mg/kg/day given orally once a day for 28 days. (2mg/ml)
Drug: Caffeine citrate 20mg/kg/day
Sterile water 1ml/kg/day given orally once a day for 28 days.
Drug: Placebo-Sterile water 1ml/kg/day
Drug page: Caffeine citrate
Caffeine citrate 20mg/kg/day given orally once daily for 28 days
Placebo-sterile water 1mg/kg/day given orally once daily for 28 days
Number of apneic events
Documentation or report of apnea of prematurity \[AoP\], a condition exhibited by cessation of breathing for ≥20 or \<20 seconds accompanied by bradycardia and/or cyanosis
Time frame: 28 days after discharge
Number of visits to healthcare professionals related to apneic events
Documentation or report of sick visit
Time frame: 28 days after discharge
Number of all-cause sick visits
Documentation or report of sick visit
Time frame: 2 months after discharge
Percentage of neonatal mortality within 2 months after discharge
Documentation of neonatal death
Time frame: 2 months after discharge
Infant/Child Developmental Assessment
Score on "Ages and Stages Questionnaire" obtained at clinic visit
Time frame: 12 months
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Studies of the drug tested here: Caffeine citrate
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