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SCDEmoCampNCT07009821

Neonatal Screening for Haemoglobinopathies EmoCamp

An observational study of SCD, run by Maddalena Casale at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
SCD
How many people
1,000 participants
Where
1 siteItaly
Study dates
Jun 2025to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The test will be carried out on all newborns in the Campania region after signing the specific informed consent of their parents or legal guardians.

Who may be able to join

  • newborns at higher risk of disease.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maddalena Casale, Professor contact

+390815665432

maddalena.casale@unicampania.it

Italy1 site

  • Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

    Naples, Italy, 80138

    Maddalena Casale, +390815665432, maddalena.casale@unicampania.it

    Maddalena Casale

Other trials in Italy

About this study

Official title: SCREENING EmoCamp_ Analysis of Major Haemoglobinopathies Among Newborns in the Campania Region

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.

Read more

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.
Read the detailed description

In the first years of life, unrecognised and untreated SCD patients have a high risk of mortality caused mainly by infection, splenic sequestration and stroke; the mortality risk is 1.1% per year in the first 10 years, but peaks in the first 3 years.

Screening may be universal or targeted, involving the neonatal population only or different age groups. Early diagnosis of disease and subsequent patient care, with timely initiation of antibiotic prophylaxis, vaccinations and parental education to recognise symptoms or signs of risk, has been shown to be effective in drastically reducing morbidity and mortality.

In Italy, newborns are screened at birth and this occasion therefore appears to be the most suitable time to perform the rapid test for the diagnosis of haemoglobinopathies.

The required amount of sample, taken from the newborn's heel, corresponds to 2 drops of blood. Subsequently, the blood sample will be blotted onto a special card made of bibula paper and absorbed by it.

The card, duly retained by the birth centers, will be sent to the Molecular and Cellular Biology laboratory of the Department of Women, Children and General and Specialist Surgery AOU-- Università degli Studi della Campania 'Luigi Vanvitelli' where the screening test will be performed.

In the event of a negative screening test, parents or legal guardians will not be recalled from the centre.

In the event of a positive screening test, parents or legal guardians will be called back by the U.O. Paediatric Haematology and Oncology centre of the AOU Luigi Vanvitelli in Naples to continue the diagnostic procedure and the taking into care of the affected subject, according to clinical practice: prescription blood count+ sideremia+ transferrin+ ferritin+ HPLC+ globin genes study.

Specifically, the test detects normal haemoglobins (F and A) and the most common haemoglobin variants: S, D, C and E.

The screening test makes it possible to anticipate a diagnosis that is often made in emergency situations, sometimes very serious or fatal, and at the same time represents a saving of NHS and SNR resources.

Conditions
SCD
Keywords
SCD, neonatal screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. determination of haemoglobin fractions

    Patients were assessed for the presence of abnormal haemoglobin fractions by means of the HPLC method on a peripheral blood drop

    Measured: Perioperative/Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07009821
Sponsor's protocol ID
EmoCamp
Acronym
EmoCamp
Status last verified
Jun 2025
First submitted
28 May 2025
Last updated
8 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Associazione Italiana Ematologia Oncologia Pediatrica. Raccomandazioni per il trattamento della Drepanocitosi in Italia. 2018.

  • Colombatti R, Martella M, Cattaneo L, Viola G, Cappellari A, Bergamo C, Azzena S, Schiavon S, Baraldi E, Dalla Barba B, Trafojer U, Corti P, Uggeri M, Tagliabue PE, Zorloni C, Bracchi M, Biondi A, Basso G, Masera N, Sainati L. Results of a multicenter universal newborn screening program for sickle cell disease in Italy: A call to action. Pediatr Blood Cancer. 2019 May;66(5):e27657. doi: 10.1002/pbc.27657. Epub 2019 Feb 5.

    PubMed 30724025

  • Desselas E, Thuret I, Kaguelidou F, Benkerrou M, de Montalembert M, Odievre MH, Lesprit E, Rumpler E, Fontanet A, Pondarre C, Brousse V. Mortality in children with sickle cell disease in mainland France from 2000 to 2015. Haematologica. 2020 Sep 1;105(9):e440-443. doi: 10.3324/haematol.2019.237602. No abstract available.

    PubMed 33054059

  • Serjeant GR, Chin N, Asnani MR, Serjeant BE, Mason KP, Hambleton IR, Knight-Madden JM. Causes of death and early life determinants of survival in homozygous sickle cell disease: The Jamaican cohort study from birth. PLoS One. 2018 Mar 1;13(3):e0192710. doi: 10.1371/journal.pone.0192710. eCollection 2018.

    PubMed 29494636

  • Shet AS, Lizarralde-Iragorri MA, Naik RP. The molecular basis for the prothrombotic state in sickle cell disease. Haematologica. 2020 Oct 1;105(10):2368-2379. doi: 10.3324/haematol.2019.239350.

    PubMed 33054077

  • Casale M, Scianguetta S, Palma T, Pinfildi L, Vallefuoco G, Capellupo MC, Roberti D, Perrotta S. Screening for sickle cell disease by point-of-care tests in Italy: pilot study on 1000 at risk children. Eur J Pediatr. 2025 Jan 28;184(2):157. doi: 10.1007/s00431-025-05988-y.

    PubMed 39875760

  • National Institutes of Health National Heart, Lung, and Blood Institute. Division of Blood Diseases and Resources. The Management of Sickle Cell Disease. NIH PUBLICATION NO. 02-2117. 2008.

  • McGann PT, Schaefer BA, Paniagua M, Howard TA, Ware RE. Characteristics of a rapid, point-of-care lateral flow immunoassay for the diagnosis of sickle cell disease. Am J Hematol. 2016 Feb;91(2):205-10. doi: 10.1002/ajh.24232. Epub 2015 Nov 26.

    PubMed 26537622

  • Kanter J, Telen MJ, Hoppe C, Roberts CL, Kim JS, Yang X. Validation of a novel point of care testing device for sickle cell disease. BMC Med. 2015 Sep 16;13:225. doi: 10.1186/s12916-015-0473-6.

    PubMed 26377572

  • Darbari DS, Sheehan VA, Ballas SK. The vaso-occlusive pain crisis in sickle cell disease: Definition, pathophysiology, and management. Eur J Haematol. 2020 Sep;105(3):237-246. doi: 10.1111/ejh.13430. Epub 2020 May 19.

    PubMed 32301178

Questions about this trial

What is this clinical trial studying?

An observational study of SCD, run by Maddalena Casale at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maddalena Casale, Professor (+390815665432, maddalena.casale@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

determination of haemoglobin fractions (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07009821, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.

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