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Retrospective Multicentre Study on the Impact of Neonatal Screening for Congenital Adrenal Hyperplasia in Italy

NCT ID: NCT06728748

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-23

Study Completion Date

2024-12-31

Brief Summary

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Oservational, retrospective, multicenter study focused on neonatal screening for Congenital Adreanl Hyperplasia.

Detailed Description

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The study refers to neonates who underwent neonatal screening for Congenital Adreanl Hyperplasia between January 2006 and December 2019 at participating centres, but only patients diagnosed with Congenital Adreanl Hyperplasia are enrolled in the study.

The primary aims are: to assess the incidence of classic Congenital Adrenal Hyperplasia in neonates who underwent neonatal screening in the reporting period; to calculate the sensibility of Neonatal Screening for classic Congenital Adrenal Hyperplasia; to calculate the positive predictive rate. The secondary aims are: to describe the biochemical, hormonal, and clinical features of neonates at diagnosis of Congenital Adrenal Hyperplasia; to assess the time required for diagnosis; to calculate the false positive rate; to calculate the diagnostic impact of neonatal screening for Congenital Adrenal Hyperplasia.

Conditions

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Congenital Adrenal Hyperplasia

Keywords

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Congenital Adrenal Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Neonatal who underwent neonatal screening for congenital adrenal hyperplasia between January 2006 and December 2019 at participating centres;
* Patients diagnosed with Congenital Adrenal Hyperplasia;
* Obtaining informed consent.

Exclusion Criteria

• None.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Federico Baronio, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

IRCCS Ospedale San Raffaele

Milan, Milano, Italy

Site Status RECRUITING

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, Torino, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona:

Verona, Verona, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Federico Baronio

Role: CONTACT

Phone: 00390512144816

Email: [email protected]

Facility Contacts

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Federico Baronio

Role: primary

Federico Baronio

Role: backup

Gianni Russo

Role: primary

Silvia Einaudi

Role: primary

Paolo Cavarzere

Role: primary

Other Identifiers

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ISCREEN

Identifier Type: -

Identifier Source: org_study_id