Neonatal Jaundice From Other Specified CausesNCT06502847
The Role of Breastmilk and Serum Exosomes in Neonatal Jaundice Due to ABO Incompatibility
An observational study of Neonatal Jaundice From Other Specified Causes and ABO Incompatibility, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Neonatal jaundice is a major global health issue that can lead to serious complications and even death if not promptly treated. ABO incompatibility is a common cause of pathological neonatal jaundice, but there are currently no specific tests to predict its severity or progression. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neonatal Jaundice From Other Specified Causes, ABO Incompatibility, ABO Hemolytic Disease
- What is being tested?
- Exosome profile study
- How many people
- 338 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 28 days
- All sexes
- Child
Study population: It is planned to include a total of 45 babies in the study, including healthy babies (n=15) in the first group, babies who developed jaundice due to ABO incompatibility but did not need treatment (n=15) in the second group, and babies who developed jaundice due to ABO incompatibility and needed treatment (n=15) in the third group.
Who may be able to join
- Newborns who are needed treatment for neonatal jaundice due to ABO incompatibility
- Newborns who are admitted to the study center due to ABO hemolytic disease
- Newborns with ABO incompatibility
- Healthy newborns
- Healthy mothers
Who cannot join
- Lack of informed consent
- Congenital abnormalities
- Maternal Liver diseases
- Neonatal liver diseases
- Sepsis
- Neonatal jaundice due to the causes other than ABO incompatibility
Show all 9Show fewer
- Acute or chronic disease state in newborn
- Maternal acute or chronic disease
- Medication or substance use effecting liver functions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Istanbul KSS Training and Research Hospital
Istanbul, Kucukcekmece, 34303
About this study
Official title: The Role of Breastmilk and Serum Exosome Profile in Prediction of the Severity and Treatment Requirement of Neonatal Jaundice Due to ABO Incompatibility
Neonatal jaundice is a major global health issue that can lead to serious complications and even death if not promptly treated. ABO incompatibility is a common cause of pathological neonatal jaundice, but there are currently no specific tests to predict its severity or progression. This project aims to study the role of exosomes in the diagnosis and treatment of newborn jaundice, focusing on their impact on infants with ABO incompatibility. The study will take place at a reference neonatal intensive care unit, involving 45 infants. Serum and breast milk samples will be collected and analyzed to determine any relationships and possible correlations.
- Being tested
- Exosome profile study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosome profile studyOther
Neonatal serum and maternal exosome profiles will be studied in all groups.
| Study group | Role | What they receive |
|---|---|---|
| Case ABO1 | Newborns who receive treatment due to the ABO Incompability will be included in this group. Receives: Other: Exosome profile study | |
| Case ABO2 | Newborns who have the ABO Incompability, but do not require treatment will be included in this group. Receives: Other: Exosome profile study | |
| Control | Healthy newborns without any disease or health condition will be included in this group Receives: Other: Exosome profile study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the participant who Need for Treatment
Association between the serum and breastmilk exosome and need for treatment due to ABO incompability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Jul 2020
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Jaundice From Other Specified CausesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yilmaz Semerci, Health Institutes of Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502847
- Sponsor's protocol ID
- 43057
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Breastmilk and Serum Exosome Profile in Prediction of the Severity and Treatment Requirement of Neonatal Jaundice Due to ABO Incompatibility
- ClinicalTrials.gov ID
- NCT06502847
- Acronym / sponsor ID
- 43057
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 16 Jul 2024 (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.
Neonatal jaundice is a major global health issue that can lead to serious complications and even death if not promptly treated. ABO incompatibility is a common cause of pathological neonatal jaundice, but there are currently no specific tests to predict its severity or progression. This project aims to study the role of exosomes in the diagnosis and treatment of newborn jaundice, focusing on their impact on infants with ABO incompatibility. The study will take place at a reference neonatal intensive care unit, involving 45 infants. Serum and breast milk samples will be collected and analyzed to determine any relationships and possible correlations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case ABO1 | – | Other: Exosome profile studyNewborns who receive treatment due to the ABO Incompability will be included in this group. |
| Case ABO2 | – | Other: Exosome profile studyNewborns who have the ABO Incompability, but do not require treatment will be included in this group. |
| Control | – | Other: Exosome profile studyHealthy newborns without any disease or health condition will be included in this group |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- It is planned to include a total of 45 babies in the study, including healthy babies (n=15) in the first group, babies who developed jaundice due to ABO incompatibility but did not need treatment (n=15) in the second group, and babies who developed jaundice due to ABO incompatibility and needed treatment (n=15) in the third group.
Key inclusion criteria (5 listed)
- Newborns who are needed treatment for neonatal jaundice due to ABO incompatibility
- Newborns who are admitted to the study center due to ABO hemolytic disease
- Newborns with ABO incompatibility
- Healthy newborns
- Healthy mothers
Key exclusion criteria (9 listed)
- Lack of informed consent
- Congenital abnormalities
- Maternal Liver diseases
- Neonatal liver diseases
- Sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exosome profile studyNeonatal serum and maternal exosome profiles will be studied in all groups. | Other | Case ABO1, Case ABO2, Control |
Primary outcome
Number of the participant who Need for Treatment
Time frame: 12 months
Association between the serum and breastmilk exosome and need for treatment due to ABO incompability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Neonatal Jaundice From Other Specified Causes and ABO Incompatibility, run by Kanuni Sultan Suleyman Training and Research Hospital 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 18 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of the participant who Need for Treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2025.