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Prevalence of Ethnic Neutropenia and Duffy Null Phenotype in Neonates

The Prevalence of Ethnic Neutropenia in Neonates

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06908616
Enrollment
1000
Registered
2025-04-03
Start date
2024-10-08
Completion date
2027-12-31
Last updated
2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neutropenia (Low White Blood Cell Count)

Keywords

Neonates, Neutropenia, Duffy null associated count

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTCord blood

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.

Sponsors

Kaplan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 1 Days
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Duffy null phenotype in neonatesAt birth (umbilical cord sample)Percentage of neonates born with the Duffy null phenotype (Fya-/Fyb-) as determined by serologic gel-based testing.

Secondary

MeasureTime frameDescription
Association between parental ethnicity and Duffy null phenotypeAt birthDistribution of Duffy null phenotype stratified by self-reported parental origin.
Prevalence of neutropenia in infants with Duffy null phenotype9-12 monthsPercentage of Duffy null infants with ANC \<1000/µL based on routine CBC performed at at 9-12 months

Countries

Israel

Contacts

Primary ContactTal Ben Ami, M.D
tal.ben.ami11@gmail.com+972-50-7414922
Backup ContactYael Zeitak, PhD
yaelze4@clalit.org.il+972-52-627-4987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026