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Recruiting Observational

The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants

NCT07324941 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-01-02
Last updated
2026-05-01

Condition(s) studied

Apnea NeonatalApnea of Prematurity

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
1 Month
Healthy volunteers
No
Inclusion Criteria: 1. Infants born before 28 weeks of gestation with a birth weight of 1250 grams or less, who received prophylactic caffeine therapy. 2. 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. 3. Infants born at less than 37 weeks of gestation, admitted to the neonatal intensive care unit, and treated with caffeine for apnea of prematurity. 4. Infants whose parents or legal guardians provided informed consent. Exclusion Criteria: 1. Infants who did not receive caffeine therapy, 2. Infants for whom an EEG could not be performed, 3. Infants with major congenital malformations such as neuromuscular disorders, central nervous system developmental abnormalities, thoracic malformations, or major cardiac anomalies, 4. Infants who were transferred to another facility within one week before or after discontinuation of caffeine therapy.

Primary outcome measure(s)

  • Assessment of apnea risk after discontinuation of caffeine therapy in preterm infants. — From enrollment to the end of treatment at 4 weeks
    Apnea of prematurity is defined as a sudden cessation of breathing lasting at least 20 seconds, or of shorter duration if accompanied by bradycardia, cyanosis, pallor, or marked hypotonia.

Trial sites (1)

FacilityCityRegionStatus
Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine Bursa Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07324941 on ClinicalTrials.gov ↗ ← All trials in Turkey