Infantile Apnea Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:

⁃ 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)

Locations
Other Locations
Zambia
University Teaching Hospital
RECRUITING
Lusaka
Contact Information
Primary
Albert Manasyan, MD
Albert.Manasyan@cidrz.org
+260 976 448 994
Backup
Waldemar A Carlo, MD
wacarlo@uabmc.edu
2059344680
Time Frame
Start Date: 2026-06-17
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 340
Treatments
Experimental: Oral Caffeine Citrate 20mg/kg/day
Caffeine Citrate 20 mg/kg/day given orally once a day for 28 days. (2mg/ml)
Placebo_comparator: Placebo
Sterile water 1ml/kg/day given orally once a day for 28 days.
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: University Teaching Hospital, Lusaka, Zambia, Centre for Infectious Disease Research in Zambia

This content was sourced from clinicaltrials.gov