The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07324941

Enrollment

100

Registered

2026-01-08

Start date

2026-01-02

Completion date

2027-01-02

Last updated

2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea Neonatal, Apnea of Prematurity

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Months

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Contacts

CONTACTSalih Çağrı Çakır

salihcagri@uludag.edu.tr+90 533 3453739

Outcome results