Apnea NeonatalNCT07324941
The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants
An observational study of Apnea Neonatal and Apnea of Prematurity, run by Uludag University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Apnea Neonatal, Apnea of Prematurity
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to 2 Jan 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine
Bursa
Salih Çağrı Çakır, Associate professor, +90 533 3453739, salihcagri@uludag.edu.tr
About this study
Official title: The Role of Electroencephalography Evaluation in Caffeine Discontinuation Timing in Premature Infants
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
- Medical subject headings
- Apnea
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start2 Jan 2026
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Apnea NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salih Çağrı Çakır, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324941
- Sponsor's protocol ID
- 2025/902/17-23
- Status last verified
- Apr 2026
- First submitted
- 18 Dec 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I am not authorized to share patient data.
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 39045901Sweet 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 36863329Nayak 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 30725638Stevenson 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 29021546Shah 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 25035312Gettings 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 40350217McCoy 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 23545760Shany E, Berger I. Neonatal electroencephalography: review of a practical approach. J Child Neurol. 2011 Mar;26(3):341-55. doi: 10.1177/0883073810384866.
PubMed 21383227Koolen 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 26736553Bourel-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 33239230Kaminska 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 31277843Muller-Putz GR. Electroencephalography. Handb Clin Neurol. 2020;168:249-262. doi: 10.1016/B978-0-444-63934-9.00018-4.
PubMed 32164856Jost 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 31086292Jiang 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 39616826Ozkan 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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Electroencephalography Evaluation in Caffeine Discontinuation Timing in Premature Infants
- ClinicalTrials.gov ID
- NCT07324941
- Acronym / sponsor ID
- 2025/902/17-23
- Conditions
- Apnea Neonatal, Apnea of Prematurity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of apnea risk after discontinuation of caffeine therapy in preterm infants.
Time frame: From enrollment to the end of treatment at 4 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 39045901Urru 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.
- Background: PubMed 36863329Sweet 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.
- Background: PubMed 30725638Nayak 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/
- Background: PubMed 29021546Stevenson 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.
- Background: PubMed 25035312Shah 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.
- Background: PubMed 40350217Gettings 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.
- Background: PubMed 23545760McCoy 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.
- Background: PubMed 21383227Shany E, Berger I. Neonatal electroencephalography: review of a practical approach. J Child Neurol. 2011 Mar;26(3):341-55. doi: 10.1177/0883073810384866.
- Background: PubMed 26736553Koolen 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.
- Background: PubMed 33239230Bourel-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.
- Background: PubMed 31277843Kaminska 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.
- Background: PubMed 32164856Muller-Putz GR. Electroencephalography. Handb Clin Neurol. 2020;168:249-262. doi: 10.1016/B978-0-444-63934-9.00018-4.
- Individual participant dataSharing planned: No. I am not authorized to share patient data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea Neonatal and Apnea of Prematurity, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salih Çağrı Çakır (+90 533 3453739, salihcagri@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of apnea risk after discontinuation of caffeine therapy in preterm infants. (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07324941, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.