The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants

NCT07324941 | Recruiting

• 1 other identifier: 2025/902/17-23
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Apnea Neonatal; Apnea of Prematurity

Outcome Measures

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.

  From enrollment to the end of treatment at 4 weeks

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine

Bursa, Turkey (Türkiye)

RECRUITING

Related Publications (19)

• 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.

  PMID: 39045901 BACKGROUND

• Sweet DG, Carnielli VP, Greisen G, Hallman M, Klebermass-Schrehof K, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update. Neonatology. 2023;120(1):3-23. doi: 10.1159/000528914. Epub 2023 Feb 15.

  PMID: 36863329 BACKGROUND

• Nayak CS, Anilkumar AC. Neonatal EEG. 2024 Feb 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536953/

  PMID: 30725638 BACKGROUND

• 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.

  PMID: 29021546 BACKGROUND

• 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.

  PMID: 25035312 BACKGROUND

• 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.

  PMID: 40350217 BACKGROUND

• 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.

  PMID: 23545760 BACKGROUND

• Shany E, Berger I. Neonatal electroencephalography: review of a practical approach. J Child Neurol. 2011 Mar;26(3):341-55. doi: 10.1177/0883073810384866.

  PMID: 21383227 BACKGROUND

• 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.

  PMID: 26736553 BACKGROUND

• 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.

  PMID: 33239230 BACKGROUND

• 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.

  PMID: 31277843 BACKGROUND

• Muller-Putz GR. Electroencephalography. Handb Clin Neurol. 2020;168:249-262. doi: 10.1016/B978-0-444-63934-9.00018-4.

  PMID: 32164856 BACKGROUND

• 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.

  PMID: 31086292 BACKGROUND

• 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.

  PMID: 39616826 BACKGROUND

• 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.

  PMID: 31236018 BACKGROUND

• 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.

  PMID: 39805735 BACKGROUND

• 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.

  PMID: 39594446 BACKGROUND

• 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.

  PMID: 31758062 BACKGROUND

• 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.

  PMID: 31236031 BACKGROUND

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Salih Çağrı Çakır

CONTACT

+90 533 3453739; salihcagri@uludag.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 8, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)