ClinicalTrials.gg
RecruitingNCT07324941Updated May 1, 2026

The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants

An observational study in Apnea Neonatal and Apnea of Prematurity, sponsored by Uludag University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged Up to 1 Month. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Uludag University · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
Up to 1 Month
Sex
All
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Study 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.

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Conditions studied

  • Apnea Neonatal
  • Apnea of Prematurity

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03

In context

Apnea

282 studies on the registry are indexed under Apnea; 54 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 78 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Uludag University is the lead sponsor of 149 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Infants born before 28 weeks of gestation with a birth weight of 1250 grams or less, who received prophylactic caffeine therapy.
  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 .

Exclusion criteria

Exclusion Criteria:

  1. Infants who did not receive caffeine therapy,
  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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes
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What researchers measure

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 weeks

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 39045901 ↗
  • 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. PubMed 36863329 ↗
  • 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/ PubMed 30725638 ↗
  • 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. PubMed 29021546 ↗
  • 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. PubMed 25035312 ↗
  • 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. PubMed 40350217 ↗
  • 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. PubMed 23545760 ↗
  • Shany E, Berger I. Neonatal electroencephalography: review of a practical approach. J Child Neurol. 2011 Mar;26(3):341-55. doi: 10.1177/0883073810384866. PubMed 21383227 ↗
  • 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. PubMed 26736553 ↗
  • 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. PubMed 33239230 ↗
  • 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. PubMed 31277843 ↗
  • Muller-Putz GR. Electroencephalography. Handb Clin Neurol. 2020;168:249-262. doi: 10.1016/B978-0-444-63934-9.00018-4. PubMed 32164856 ↗
  • 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. PubMed 31086292 ↗
  • 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. PubMed 39616826 ↗
  • 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. PubMed 31236018 ↗
  • 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. PubMed 39805735 ↗
  • 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. PubMed 39594446 ↗
  • 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. PubMed 31758062 ↗
  • 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. PubMed 31236031 ↗

Individual participant data

Plan to share: No — I am not authorized to share patient data.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.

Of 35 observational studies under Apnea, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 38. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2025
First posted
Jan 8, 2026
StartActual
Jan 2, 2026
Primary completionEst.
Jan 2, 2027
CompletionEst.
Jan 2, 2027
Last update
May 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07324941
Lead sponsor
Uludag University
Responsible party
Salih Çağrı Çakır (Associate professor, Uludag University) — Principal investigator
First posted
Jan 8, 2026
Start date
Jan 2, 2026
Primary completion
Jan 2, 2027 (estimated)
Completion
Jan 2, 2027 (estimated)
Last update
May 1, 2026

Study contacts

Salih Çağrı Çakır
Contact
salihcagri@uludag.edu.tr
+90 533 3453739

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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