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Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Jun 1, 2026 to Jun 17, 2026 · Site details revisedv13 Show 2 more changesShow less
    • Start date changed from estimate of Jun 1, 2026 to Jun 17, 2026
    • Site details revised
  2. Start date: Apr 1, 2026 to Jun 1, 2026 Primary completion pushed from Mar 31, 2027 to May 31, 2027v12 Show 1 more changeShow less
    • Primary completion pushed from Mar 31, 2027 to May 31, 2027
  3. Start date: Jan 1, 2026 to Apr 1, 2026 Primary completion date: Dec 31, 2026 to Mar 31, 2027 · Completion date: Dec 31, 2026 to Jun 30, 2027v11 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2026 to Mar 31, 2027
    • Completion date: Dec 31, 2026 to Jun 30, 2027
  4. Start date: Sep 1, 2025 to Jan 1, 2026 Primary completion date: Aug 31, 2026 to Dec 31, 2026v10 Show 1 more changeShow less
    • Primary completion date: Aug 31, 2026 to Dec 31, 2026
  5. Start date: Jun 1, 2025 to Sep 1, 2025 Primary completion date: May 31, 2026 to Aug 31, 2026v9 Show 1 more changeShow less
    • Primary completion date: May 31, 2026 to Aug 31, 2026
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: Apr 1, 2025 to Jun 1, 2025 Primary completion date: Dec 30, 2025 to May 31, 2026 · Completion date: Nov 30, 2026 to Dec 31, 2026 · Site contact updatedv8 Show 3 more changesShow less
    • Primary completion date: Dec 30, 2025 to May 31, 2026
    • Completion date: Nov 30, 2026 to Dec 31, 2026
    • Site contact updated
  2. Start date: Feb 1, 2025 to Apr 1, 2025 Primary completion date: Nov 30, 2025 to Dec 30, 2025v7 Show 1 more changeShow less
    • Primary completion date: Nov 30, 2025 to Dec 30, 2025
  3. Start date: Dec 1, 2024 to Feb 1, 2025v6
  4. Start date: Oct 1, 2024 to Dec 1, 2024 Primary completion date: Sep 30, 2025 to Nov 30, 2025 · Completion date: Sep 30, 2026 to Nov 30, 2026 · Site contact updatedv5 Show 3 more changesShow less
    • Primary completion date: Sep 30, 2025 to Nov 30, 2025
    • Completion date: Sep 30, 2026 to Nov 30, 2026
    • Site contact updated
  5. Start date: Sep 1, 2024 to Oct 1, 2024 Primary completion date: Aug 31, 2026 to Sep 30, 2025v4 Show 1 more changeShow less
    • Primary completion date: Aug 31, 2026 to Sep 30, 2025
  6. Study title shortened, about 4 wordsv3 See this version in full on ClinicalTrials.gov ↗
  7. Study description revisedv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06518603
Lead Sponsor University of Alabama at Birmingham
Collaborators: University Teaching Hospital, Lusaka, Zambia, Centre for Infectious Disease Research in Zambia
Conditions Premature Infant Disease, Apnea of Prematurity, Development, Infant
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov