Abstract:
Caffeine is the treatment of choice for apnea and bradycardia in preterm newborns. Preterm infants born between 23 and approximately 32 weeks of gestation receive an initial dose of caffeine usually in their first day of life, followed by a maintenance dose once daily for a prolonged period. CAPPUCINO study aims to validate a non-invasive method for caffeine monitoring by saliva sampling, provide insights into the pharmacokinetics and pharmacodynamics of caffeine, and explore the potential analgesic effects of caffeine in preterm newborns. The findings could contribute to personalized neonatal care and optimized caffeine dosing strategies. Design of the study was carefully planned due to extreme vulnerability of the subjects of our research, specific conditions in neonatal intensive care units, technical challenges using and sampling tiny volumes in laboratory analysis and minimizing extra work load for the nursing staff. All the patients will be enrolled after obtaining an informed written consent by their legal guardians. During the study, all participants will receive standard care, undergo routine neonatal examinations, and the study medication (caffeine citrate) will be used in accordance with the SmPC. The intervention in this study consists solely of the non-invasive collection of saliva samples. The study does not require power calculations for hypothesis testing, as the primary outcome will be analyzed descriptively. However, the planned sample size enables the generation of reliable descriptive statistics and facilitates potential subgroup analyses.
