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Updated: Apr 9, 2026

A Precision Medicine Tool for Measurement and Monitoring of Hemoglobin S in Sickle Cell Disease Patients Receiving Transfusion Therapy
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Protocol for a Multicentric Cohort Study on Neonatal Screening and Early Interventions for Sickle Cell Disease Among

Suchitra Surve1, Mahendra Thakor2, Manisha Madkaikar3

  • 1Model Rural Research Health Unit (MRHRU), ICMR-National Institute for Research in Reproductive Health (NIRRCH), Dahanu 401601, Maharashtra, India.

Diagnostics (Basel, Switzerland)
|March 28, 2025
PubMed

Insights

Newborn screening for sickle cell disease (SCD) in India is crucial for early detection and improved outcomes. This study establishes a framework for widespread screening and comprehensive care for affected children.

Area of Science:

  • Genetics
  • Pediatrics
  • Public Health

Background:

  • Sickle cell disease (SCD) significantly increases infant and childhood morbidity and mortality.
  • Early detection through neonatal screening is vital for managing SCD and preventing complications.
  • Neonatal screening enables early diagnosis, family support, and timely medical intervention.

Purpose of the Study:

  • To implement and evaluate a newborn screening protocol for SCD in high-prevalence Indian states.
  • To assess the magnitude of SCD and the benefits of early comprehensive care.
  • To establish genotypic and phenotypic correlations in screened newborns.

Main Methods:

  • A prospective cohort study across seven sites in six high-SCD prevalence Indian states.
  • Screening of newborns using High-Performance Liquid Chromatography (HPLC) on cord blood or heel prick samples.
  • Confirmation of sickle cell genotype (SS) at 6 weeks, cascade screening, and follow-up for up to five years with standard care protocols.

Main Results:

  • The study protocol is designed to facilitate the implementation of newborn screening programs.
  • It aims to establish effective follow-up strategies for infants diagnosed with SCD.
  • The findings will provide data on SCD prevalence and the impact of early intervention.

Conclusions:

  • This protocol will lay the foundation for implementing nationwide newborn screening for SCD in India.
  • It will guide the development of strategic frameworks for managing haemoglobinopathies.
  • The study supports the integration of comprehensive care into public health initiatives for SCD.

Keywords:
comprehensive careearly interventionshaemoglobinopathiesnewborn screeningsickle cell diseasetribal population

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