Neutropenia (Low White Blood Cell Count)NCT06908616
Prevalence of Ethnic Neutropenia and Duffy Null Phenotype in Neonates
An observational study of Neutropenia (Low White Blood Cell Count), run by Kaplan Medical Center at 1 site in Israel.
Trial summary
This is a prospective observational study designed to assess the prevalence of the Duffy null phenotype (associated with ethnic neutropenia) in neonates born at Kaplan Medical Center. Blood samples will be collected from umbilical cords (non-invasively) to evaluate Duffy antigen expression. Read more about this study
- Who is it for?
- Ages 1 minute to 1 day
- Conditions the study is for
- Neutropenia (Low White Blood Cell Count)
- What is being tested?
- Cord blood
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Oct 2024to 31 Dec 2027
- 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 1 minute to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: Neonates born at Kaplan Medical Center
Who may be able to join
- Neonates born at Kaplan Medical Center between 1.9.2024 and 31.12.2025
- Parental informed consent obtained
- Umbilical cord blood available for routine testing
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Kaplan Medical Center
Rehovot, Israel, 7661041
Tal Ben Ami, MD, +972-50-7414922, tal.ben.ami11@gmail.com
Yael Zeitak, PhD, +972-52-627-4987, yaelze4@clalit.org.il
About this study
Official title: The Prevalence of Ethnic Neutropenia in Neonates
This is a prospective observational study designed to assess the prevalence of the Duffy null phenotype (associated with ethnic neutropenia) in neonates born at Kaplan Medical Center. Blood samples will be collected from umbilical cords (non-invasively) to evaluate Duffy antigen expression. Data on ethnicity, perinatal factors, and routine blood counts at 9-12 months (when available) will also be collected to correlate phenotype with absolute neutrophil count (ANC).
Read the detailed description
This is a prospective, observational cohort study designed to evaluate the prevalence of the Duffy null phenotype (Fya-/Fyb-) and its association with ethnic neutropenia in neonates born at Kaplan Medical Center in Israel. The Duffy null phenotype has been linked to lower peripheral neutrophil counts without increased infection risk in certain ethnic groups, a condition commonly referred to as benign ethnic neutropenia.
Cord blood samples will be collected from approximately 1,000 neonates during routine G6PD testing. An additional 3 mL will be obtained non-invasively from the umbilical cord after labour to determine the expression of Duffy antigens using serologic gel testing. Parental consent will be obtained, and information regarding ethnicity and family history of neutropenia will be collected.
Participants identified with the Duffy null phenotype will be followed through electronic health records to assess their neutrophil counts during routine blood screening at 9-12 months of age. The study will analyze associations between Duffy phenotype, neutropenia prevalence, and parental ethnic origin.
Findings may support improved diagnostic clarity around neonatal neutropenia and help reduce unnecessary interventions in otherwise healthy infants with genetically determined low neutrophil counts.
- Conditions
- Neutropenia (Low White Blood Cell Count)
- Being tested
- Cord blood
- Keywords
- Neonates, Neutropenia, Duffy null associated count
- Medical subject headings
- Neutropenia, Leukopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord bloodDiagnostic test
Cord blood samples will be collected during routine G6PD testing. An additional 3 mL will be obtained non-invasively from the umbilical cord to determine the expression of Duffy antigens using serologic gel testing.
| Study group | Role | What they receive |
|---|---|---|
| Neonatal birth cohort | Neonates born at Kaplan Medical Center whose cord blood is tested for Duffy antigen status and complete blood count. Follow-up neutrophil data is collected at 9-12 months if available. Receives: Diagnostic Test: Cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Duffy null phenotype in neonates
Percentage of neonates born with the Duffy null phenotype (Fya-/Fyb-) as determined by serologic gel-based testing.
Measured: At birth (umbilical cord sample)
Secondary outcomes (2)
Prevalence of neutropenia in infants with Duffy null phenotype
Percentage of Duffy null infants with ANC <1000/µL based on routine CBC performed at at 9-12 months
Measured: 9-12 months
Association between parental ethnicity and Duffy null phenotype
Distribution of Duffy null phenotype stratified by self-reported parental origin.
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start8 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neutropenia (Low White Blood Cell Count)Studies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tal Ben-Ami, Kaplan Medical Center
- Investigators
- Tal Ben Ami, MD, Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908616
- Sponsor's protocol ID
- KMC-24-0090
- Other IDs
- KMC-24-0090
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study involves neonates and is based on anonymized samples; individual-level data will not be shared due to privacy and ethical considerations.
Publications
Gay K, Dulay K, Ravindranath Y, Savasan S. Duffy-Null Phenotype-Associated Neutropenia is the Most Common Etiology for Leukopenia/Neutropenia Referrals to a Tertiary Children's Hospital. J Pediatr. 2023 Nov;262:113608. doi: 10.1016/j.jpeds.2023.113608. Epub 2023 Jul 6.
PubMed 37419240Rappoport N, Simon AJ, Lev A, Yacobi M, Kaplinsky C, Weingarten M, Somech R, Amariglio N, Rechavi G. Correlation between 'ACKR1/DARC null' polymorphism and benign neutropenia in Yemenite Jews. Br J Haematol. 2015 Sep;170(6):892-5. doi: 10.1111/bjh.13345. Epub 2015 Mar 26. No abstract available.
PubMed 25817587Atallah-Yunes SA, Ready A, Newburger PE. Benign ethnic neutropenia. Blood Rev. 2019 Sep;37:100586. doi: 10.1016/j.blre.2019.06.003. Epub 2019 Jun 21.
PubMed 31255364
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Ethnic Neutropenia in Neonates
- ClinicalTrials.gov ID
- NCT06908616
- Acronym / sponsor ID
- KMC-24-0090
- Conditions
- Neutropenia (Low White Blood Cell Count)
- Keywords
- Neonates, Neutropenia, Duffy null associated count
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Apr 2025 (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.
This is a prospective observational study designed to assess the prevalence of the Duffy null phenotype (associated with ethnic neutropenia) in neonates born at Kaplan Medical Center. Blood samples will be collected from umbilical cords (non-invasively) to evaluate Duffy antigen expression. Data on ethnicity, perinatal factors, and routine blood counts at 9-12 months (when available) will also be collected to correlate phenotype with absolute neutrophil count (ANC).
Detailed description
This is a prospective, observational cohort study designed to evaluate the prevalence of the Duffy null phenotype (Fya-/Fyb-) and its association with ethnic neutropenia in neonates born at Kaplan Medical Center in Israel. The Duffy null phenotype has been linked to lower peripheral neutrophil counts without increased infection risk in certain ethnic groups, a condition commonly referred to as benign ethnic neutropenia.
Cord blood samples will be collected from approximately 1,000 neonates during routine G6PD testing. An additional 3 mL will be obtained non-invasively from the umbilical cord after labour to determine the expression of Duffy antigens using serologic gel testing. Parental consent will be obtained, and information regarding ethnicity and family history of neutropenia will be collected.
Participants identified with the Duffy null phenotype will be followed through electronic health records to assess their neutrophil counts during routine blood screening at 9-12 months of age. The study will analyze associations between Duffy phenotype, neutropenia prevalence, and parental ethnic origin.
Findings may support improved diagnostic clarity around neonatal neutropenia and help reduce unnecessary interventions in otherwise healthy infants with genetically determined low neutrophil counts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonatal birth cohort | – | Diagnostic Test: Cord bloodNeonates born at Kaplan Medical Center whose cord blood is tested for Duffy antigen status and complete blood count. Follow-up neutrophil data is collected at 9-12 months if available. |
Who may qualify
- Ages
- 1 minute to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates born at Kaplan Medical Center
Key inclusion criteria (3 listed)
- Neonates born at Kaplan Medical Center between 1.9.2024 and 31.12.2025
- Parental informed consent obtained
- Umbilical cord blood available for routine testing
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Cord bloodCord blood samples will be collected during routine G6PD testing. An additional 3 mL will be obtained non-invasively from the umbilical cord to determine the expression of Duffy antigens using serologic gel testing. | Diagnostic test | Neonatal birth cohort |
Primary outcome
Prevalence of Duffy null phenotype in neonates
Time frame: At birth (umbilical cord sample)
Percentage of neonates born with the Duffy null phenotype (Fya-/Fyb-) as determined by serologic gel-based testing.
2 secondary outcomes
Prevalence of neutropenia in infants with Duffy null phenotype
Time frame: 9-12 months
Association between parental ethnicity and Duffy null phenotype
Time frame: At birth
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 6 Apr 2025.
- Background: PubMed 37419240Gay K, Dulay K, Ravindranath Y, Savasan S. Duffy-Null Phenotype-Associated Neutropenia is the Most Common Etiology for Leukopenia/Neutropenia Referrals to a Tertiary Children's Hospital. J Pediatr. 2023 Nov;262:113608. doi: 10.1016/j.jpeds.2023.113608. Epub 2023 Jul 6.
- Background: PubMed 25817587Rappoport N, Simon AJ, Lev A, Yacobi M, Kaplinsky C, Weingarten M, Somech R, Amariglio N, Rechavi G. Correlation between 'ACKR1/DARC null' polymorphism and benign neutropenia in Yemenite Jews. Br J Haematol. 2015 Sep;170(6):892-5. doi: 10.1111/bjh.13345. Epub 2015 Mar 26. No abstract available.
- Background: PubMed 31255364Atallah-Yunes SA, Ready A, Newburger PE. Benign ethnic neutropenia. Blood Rev. 2019 Sep;37:100586. doi: 10.1016/j.blre.2019.06.003. Epub 2019 Jun 21.
- Individual participant dataSharing planned: No. The study involves neonates and is based on anonymized samples; individual-level data will not be shared due to privacy and ethical considerations.
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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.
Tal Ben Ami, MD principal investigator
Kaplan Medical Center
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 Neutropenia (Low White Blood Cell Count), run by Kaplan Medical Center at 1 site in Israel.
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 3 inclusion and 1 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 6 Apr 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 Israel. 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 Tal Ben Ami, M.D (+972-50-7414922, tal.ben.ami11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Duffy null phenotype in neonates (time frame: At birth (umbilical cord sample)). 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 NCT06908616, which also lists 3 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 6 Apr 2025.