Strategies for cessation of caffeine administration in preterm infants.
Silvana Am Urru, Milena Geist, Rebecka Carlinger...
https://pubmed.ncbi.nlm.nih.gov/39045901Actively Recruiting
Age: 0 - 1Month
All Genders
ID07324941
The Role of Electroencephalography Evaluation in Caffeine Discontinuation Timing in Premature Infants
Led by Uludag University · Updated on 2026-05-01
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether electroencephalography (EEG) can reliably assess brain maturation in preterm infants to guide the safe stopping of caffeine therapy without causing a return of apnea. The study focuses on infants born prematurely who are receiving caffeine to manage apnea of prematurity, a condition causing pauses in breathing. The study involves observing infants who have been treated with caffeine. EEG assessments will be conducted when it is time to consider stopping caffeine treatment, to help determine if the infant's brain has matured enough to discontinue therapy safely. There are no experimental treatments; instead, the study monitors and evaluates EEG data alongside clinical outcomes. Participants will be monitored from enrollment until four weeks after caffeine therapy ends. Researchers will evaluate apnea risk after stopping caffeine by reviewing EEG results and clinical observations. The study includes infants born before 37 weeks gestation who have received caffeine treatment, with follow-up assessments to ensure safety and gather reliable data on apnea recurrence.
CONDITIONS
Brief Title
The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants
Who Can Participate
Age: 0 - 1Month
All Genders
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 4 weeks
Participants are monitored to assess apnea risk after discontinuation of caffeine therapy.
Regular assessments during caffeine therapy discontinuation period
Trial Site Locations
Total: 1 location
1
Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine
Bursa, Turkey (Türkiye)
Actively Recruiting
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Research Team
S
Salih Çağrı Çakır
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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N J Stevenson, L Oberdorfer, N Koolen...
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Bláthnaid McCoy, Cecil D Hahn
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Ninah Koolen, Anneleen Dereymaeker, Okko Rasanen...
https://pubmed.ncbi.nlm.nih.gov/26736553Normal EEG during the neonatal period: maturational aspects from premature to full-term newborns.
Emilie Bourel-Ponchel, Sophie Gueden, Danièle Hasaerts...
https://pubmed.ncbi.nlm.nih.gov/33239230