Prevalence of Ethnic Neutropenia and Duffy Null Phenotype in Neonates

NCT06908616 | Recruiting

• 1 other identifier: KMC-24-0090
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Neutropenia (Low White Blood Cell Count)

Keywords

Neonates; Neutropenia; Duffy null associated count

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Prevalence of neutropenia in infants with Duffy null phenotype

  9-12 months

• Association between parental ethnicity and Duffy null phenotype

  At birth

Study Arms (1)

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.

Diagnostic Test: Cord blood

Interventions

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.

Neonatal birth cohort

Eligibility Criteria

• Age: 1 Minute - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates born at Kaplan Medical Center

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Kaplan Medical Center: lead

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel, 7661041, Israel

RECRUITING

Related Publications (3)

• 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.

  PMID: 37419240 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.

  PMID: 25817587 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.

  PMID: 31255364 BACKGROUND

MeSH Terms

Conditions

Neutropenia; Leukopenia

Interventions

Cordocentesis

Condition Hierarchy (Ancestors)

Agranulocytosis; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tal Ben Ami, MD

  Kaplan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Hemato-Oncology

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: October 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)