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Neonatal Screening for Haemoglobinopathies EmoCamp

NCT07009821 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-06-08

No results posted yet for this study

Summary

Hereditary haemoglobin defects defined under the term haemoglobinopathies represent the most frequent congenital diseases worldwide.

The proposed observational study is aimed at determining the prevalence of haemoglobinopathies in newborns in the Campania Region. The neonatal screening test will be performed at the birth centers in Campania Region, before the newborn's discharge, at the same time as the sampling for neonatal screening required by law.

The main objective of this study is to evaluate the feasibility and impact of the screening programme performed at the birth centers on the earliness of diagnosis and the annual rate of sickle cell anaemia diagnosis in children. The secondary objective is to evaluate the benefits of early diagnosis of SCD in children as measured by two endpoints:

* Improved disease management and early initiation of conventional therapy with reduction of complications, potentially fatal;
* Difference between costs related to the neonatal screening programme and estimated costs related to conventional screening and treatment resulting from complications that may arise with late diagnosis.

Conditions

Sponsors & Collaborators

  • Maddalena Casale

    lead OTHER

Principal Investigators

  • Maddalena Casale, Professor · University of Campania Luigi Vanvitelli

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-06-30
Completion
2027-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07009821 on ClinicalTrials.gov