Oral Caffeine Citrate to Prevent Apnea and Support Development in Moderately Preterm Infants in Zambia

What this Trial Is About

This research aims to determine if continuing caffeine citrate treatment after hospital discharge can prevent apneic events causing sick visits in moderately preterm infants. It also evaluates whether caffeine use improves developmental outcomes at 12 months of age. The study compares caffeine citrate to a placebo to assess its effects on apnea and infant development. Participants receive either caffeine citrate at 20mgkgday or a placebo of sterile water orally once daily for up to 28 days following hospital discharge. The doses are prepared based on the infants weight prior to discharge and are not adjusted afterward. Parents or guardians administer the medication daily and keep a diary of symptoms and apneic events. Weekly phone calls monitor the infants condition until day 28, with an additional follow-up call at 2 months. Participants return to the clinic for physical examinations at 28 days and 2 months after discharge. At 12 months, infants undergo a neurodevelopmental assessment using the Ages and Stages Questionnaire. Data collected includes the number of apneic events, healthcare visits related to apnea, all-cause sick visits, neonatal mortality, and developmental outcomes. Study data is securely stored and managed to protect participant confidentiality throughout the trial.

Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia