Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia," aims to find out if giving caffeine citrate to moderately preterm infants after they leave the hospital can help prevent breathing issues known as apneic events. These events can cause parents to take their babies back to the doctor. The study will also check if using caffeine improves the babies' development by the time they are 12 months old. Researchers will compare the effects of caffeine citrate with a placebo, which is a harmless liquid that looks like the real treatment but has no active ingredients.

To be eligible for the trial, infants must be born between 29 to 34 weeks of gestation and must be stable enough to stop other medications. Parents will play an active role by giving their baby either caffeine or the placebo every day for up to 28 days after leaving the hospital. They will also keep a diary of their baby’s symptoms and apneic events, have weekly phone check-ins with the research team, and return to the clinic for physical and developmental check-ups at various points, including when their child is 12 months old. This trial is not yet recruiting participants, but it aims to help improve care for preterm infants in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Newborns:
• • 1. 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,
• • 2. On methylxanthines with plans to discontinue on methylxanthine,
• • 3. Off oxygen therapy for \>48 hours at the time of evaluation for eligibility,
• • 4. Receiving full daily feeds,
• • 5. Deemed stable and ready to go off caffeine as recommended by the Neonatologist
• • 6. 18+ years of age (parent)
• Exclusion Criteria:
• • 1. Newborns with neuromuscular conditions affecting respiration,
• • 2. Major congenital malformations and genetic disorders,
• • 3. Unable to obtain parental or guardian consent