The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 1
SponsorUludag University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Preterm infants admitted to the neonatal intensive care unit, born at less than 37 weeks of gestation and receiving caffeine therapy, will be included in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Assessment of apnea risk after discontinuation of caffeine therapy in preterm infants.
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.
Time frame
From enrollment to the end of treatment at 4 weeksSponsors and contacts
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Source ClinicalTrials.gov