The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants
NCT ID: NCT07324941
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2026-01-02
2027-01-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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.
1 Month
ALL
No
Sponsors
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Uludag University
OTHER
Responsible Party
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Salih Çağrı Çakır
Associate professor
Locations
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Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine
Bursa, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Urru SA, Geist M, Carlinger R, Bodrero E, Bruschettini M. Strategies for cessation of caffeine administration in preterm infants. Cochrane Database Syst Rev. 2024 Jul 24;7(7):CD015802. doi: 10.1002/14651858.CD015802.pub2.
Dodson A, Campbell F. Biotin inclusions: a potential pitfall in immunohistochemistry avoided. Histopathology. 1999 Feb;34(2):178-9. No abstract available.
Nayak CS, Anilkumar AC. Neonatal EEG. 2024 Feb 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536953/
Stevenson NJ, Oberdorfer L, Koolen N, O'Toole JM, Werther T, Klebermass-Schrehof K, Vanhatalo S. Functional maturation in preterm infants measured by serial recording of cortical activity. Sci Rep. 2017 Oct 11;7(1):12969. doi: 10.1038/s41598-017-13537-3.
Shah NA, Wusthoff CJ. How to use: amplitude-integrated EEG (aEEG). Arch Dis Child Educ Pract Ed. 2015 Apr;100(2):75-81. doi: 10.1136/archdischild-2013-305676. Epub 2014 Jul 17.
Gettings JV, Soul JS. Updates in Neonatal Seizures. Clin Perinatol. 2025 Jun;52(2):375-393. doi: 10.1016/j.clp.2025.02.008. Epub 2025 Apr 1.
McCoy B, Hahn CD. Continuous EEG monitoring in the neonatal intensive care unit. J Clin Neurophysiol. 2013 Apr;30(2):106-14. doi: 10.1097/WNP.0b013e3182872919.
Shany E, Berger I. Neonatal electroencephalography: review of a practical approach. J Child Neurol. 2011 Mar;26(3):341-55. doi: 10.1177/0883073810384866.
Koolen N, Dereymaeker A, Rasanen O, Jansen K, Vervisch J, Matic V, De Vos M, Naulaers G, Van Huffel S, Vanhatalo S. Data-driven metric representing the maturation of preterm EEG. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:1492-5. doi: 10.1109/EMBC.2015.7318653.
Bourel-Ponchel E, Gueden S, Hasaerts D, Heberle C, Malfilatre G, Mony L, Vignolo-Diard P, Lamblin MD. Normal EEG during the neonatal period: maturational aspects from premature to full-term newborns. Neurophysiol Clin. 2021 Jan;51(1):61-88. doi: 10.1016/j.neucli.2020.10.004. Epub 2020 Nov 22.
Kaminska A, Eisermann M, Plouin P. Child EEG (and maturation). Handb Clin Neurol. 2019;160:125-142. doi: 10.1016/B978-0-444-64032-1.00008-4.
Muller-Putz GR. Electroencephalography. Handb Clin Neurol. 2020;168:249-262. doi: 10.1016/B978-0-444-63934-9.00018-4.
Jost K, Datta AN, Frey UP, Suki B, Schulzke SM. Heart rate fluctuation after birth predicts subsequent cardiorespiratory stability in preterm infants. Pediatr Res. 2019 Sep;86(3):348-354. doi: 10.1038/s41390-019-0424-6. Epub 2019 May 13.
Jiang JK, Wang C. Maturational delay in the brainstem auditory pathway of very preterm babies with apnoea. Early Hum Dev. 2025 Jan;200:106164. doi: 10.1016/j.earlhumdev.2024.106164. Epub 2024 Nov 28.
Ozkan H, Erdeve O, Kutman HGK. Turkish Neonatal Society guideline on the management of respiratory distress syndrome and surfactant treatment. Turk Pediatri Ars. 2018 Dec 25;53(Suppl 1):S45-S54. doi: 10.5152/TurkPediatriArs.2018.01806. eCollection 2018.
Kaempfen S, Hug M, Sanchez C, Delgado-Eckert E, Schulzke SM. Heart Rate Variability Does Not Predict Recurrence of Apnoea of Prematurity After Ceasing Caffeine Therapy: A Prospective Cohort Study. Acta Paediatr. 2025 Jun;114(6):1371-1378. doi: 10.1111/apa.17579. Epub 2025 Jan 13.
Thompson L, Werthammer JW, Gozal D. Apnea of Prematurity and Oxidative Stress: Potential Implications. Antioxidants (Basel). 2024 Oct 27;13(11):1304. doi: 10.3390/antiox13111304.
Ji D, Smith PB, Clark RH, Zimmerman KO, Laughon M, Ku L, Greenberg RG. Wide variation in caffeine discontinuation timing in premature infants. J Perinatol. 2020 Feb;40(2):288-293. doi: 10.1038/s41372-019-0561-0. Epub 2019 Nov 22.
Acunas B, Uslu S, Bas AY. Turkish Neonatal Society guideline for the follow-up of high-risk newborn infants. Turk Pediatri Ars. 2018 Dec 25;53(Suppl 1):S180-S195. doi: 10.5152/TurkPediatriArs.2018.01817. eCollection 2018.
Other Identifiers
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2025/902/17-23
Identifier Type: -
Identifier Source: org_study_id
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