Using EEG to time stopping caffeine in premature infants

The Role of Electroencephalography Evaluation in Caffeine Discontinuation Timing in Premature Infants

This study will see if EEG brain recordings can help doctors decide when to stop caffeine treatment in preterm infants so apnea does not come back.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: N/A to 1 Month
• Sex: All
• Sponsor: Uludag University (Academic / other)
• Locations: 1 site (Bursa)
• Trial ID: NCT07324941 on ClinicalTrials.gov

What this trial studies

This is an observational study of premature infants treated with caffeine for apnea of prematurity. At the planned point of stopping caffeine, infants will have an electroencephalogram (EEG) to measure functional brain maturation. Researchers will compare EEG findings with whether apnea recurs after caffeine is discontinued. No experimental treatments are given and standard clinical care continues while data are collected at a single neonatal intensive care unit.

Who should consider this trial

Good fit: Eligible infants are those born preterm who received prophylactic or therapeutic caffeine (including infants <28 weeks or those <32 weeks who required invasive ventilation) and whose parents consent to EEG recording.

Not a fit: Infants with major congenital anomalies, those who cannot undergo EEG, those who never received caffeine, or those transferred around the discontinuation period are unlikely to benefit from the study findings.

Why it matters

Potential benefit: If successful, using EEG to guide when to stop caffeine could reduce apnea recurrences and avoid unnecessary prolonged caffeine exposure and hospital stays.

How similar studies have performed: Using EEG to time caffeine discontinuation is relatively novel with only limited prior data and no large, definitive studies demonstrating clear success.

Eligibility criteria

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.

Where this trial is running

Bursa

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

Study contacts

• Study coordinator: Salih Çağrı Çakır

Conditions Apnea Neonatal; Apnea of Prematurity