The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants

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.

Recruiting

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Key information

Conditions

Apnea Neonatal Apnea Apnea of Prematurity Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine

Bursa, Turkey (Türkiye)

Location status: Recruiting

Location contact

Salih Çağrı Çakır, Associate professor

CONTACT

[email protected]

+90 533 3453739

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Assessment of apnea risk after discontinuation of caffeine therapy in preterm infants.

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Salih Çağrı Çakır

CONTACT

[email protected]

+90 533 3453739

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jan 8, 2026
Registry last updated: May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed