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| ID | Type | Description | Link |
|---|---|---|---|
| KMC-24-0090 | Other Identifier | Kaplan Medical Center Ethical Committee |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cord blood | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At birth (umbilical cord sample) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9-12 months |
| Association between parental ethnicity and Duffy null phenotype |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates born at Kaplan Medical Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tal Ben Ami, M.D | Contact | +972-50-7414922 | tal.ben.ami11@gmail.com | |
| Yael Zeitak, PhD | Contact | +972-52-627-4987 | yaelze4@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Tal Ben Ami, MD | Kaplan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaplan Medical Center | Recruiting | Rehovot | Israel | 7661041 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37419240 | Background | 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. | |
| 25817587 | Background | Rappoport 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. |
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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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| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D007970 | Leukopenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017218 | Cordocentesis |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Distribution of Duffy null phenotype stratified by self-reported parental origin.
| At birth |
| 31255364 | Background | Atallah-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. |
| D007960 |
| Leukocyte Disorders |
| D003933 | Diagnosis |
| D019152 | Paracentesis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |