The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants

Recruiting now

Conditions studied: Apnea Neonatal, Apnea of Prematurity

In brief

The aim of this observational study is to investigate whether functional maturation assessment by electroencephalography in preterm infants can provide reliable data for the safe discontinuation of caffeine therapy without recurrence of apnea. In preterm infants receiving caffeine therapy, an assessment of maturation will be performed by EEG at the time when discontinuation of caffeine treatment is planned.

Key facts

Study ID

NCT07324941

Run by

Uludag University

People needed

100

Starts

2026-01-02

Expected to finish

2027-01-02

Last updated by the study team

2026-05-01

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born before 28 weeks of gestation with a birth weight of 1250 grams or less, who received prophylactic caffeine therapy.
• Infants with a birth weight greater than 1250 grams and a gestational age below 32 weeks, who required invasive mechanical ventilation and were started on prophylactic caffeine therapy.
• Infants born at less than 37 weeks of gestation, admitted to the neonatal intensive care unit, and treated with caffeine for apnea of prematurity.
• Infants whose parents or legal guardians provided informed consent.

You may not qualify if…

• Infants who did not receive caffeine therapy,
• Infants for whom an EEG could not be performed,
• Infants with major congenital malformations such as neuromuscular disorders, central nervous system developmental abnormalities, thoracic malformations, or major cardiac anomalies,
• Infants who were transferred to another facility within one week before or after discontinuation of caffeine therapy.

Where it is running

• Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine — Bursa, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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