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.
Who can participate
Age range
1 Month
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of apnea risk after discontinuation of caffeine therapy in preterm infants.
Timeframe: From enrollment to the end of treatment at 4 weeks
. 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.