Impact of neonatal screening for congenital adrenal hyperplasia in Italy
Retrospective Multicentre Study on the Impact of Neonatal Screening for Congenital Adrenal Hyperplasia in Italy
This study looks at how well newborn screening for congenital adrenal hyperplasia works in Italy and what it means for babies diagnosed with the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 4 sites (Bologna and 3 other locations) |
| Trial ID | NCT06728748 on ClinicalTrials.gov |
What this trial studies
This observational, retrospective, multicenter study examines the outcomes of neonatal screening for congenital adrenal hyperplasia (CAH) in Italy from January 2006 to December 2019. It focuses on neonates diagnosed with CAH and aims to assess the incidence, sensitivity, and positive predictive rate of the screening process. Additionally, the study will evaluate the biochemical, hormonal, and clinical features of affected neonates at diagnosis, as well as the time taken for diagnosis and the false positive rate associated with the screening. The findings will provide insights into the effectiveness of neonatal screening for CAH.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates who underwent screening for congenital adrenal hyperplasia in Italy between January 2006 and December 2019 and were subsequently diagnosed with the condition.
Not a fit: Patients who did not undergo neonatal screening for congenital adrenal hyperplasia or were not diagnosed with the condition will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of neonatal screening effectiveness, leading to improved early diagnosis and management of congenital adrenal hyperplasia.
How similar studies have performed: Other studies have shown success in evaluating neonatal screening programs for congenital adrenal hyperplasia, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna and 3 other locations
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milano, Italy (Recruiting)
- Azienda Ospedaliera Città della Salute e della Scienza di Torino — Torino, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Integrata Verona: — Verona, Italy (Recruiting)
Study contacts
- Principal investigator: Federico Baronio, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Federico Baronio
- Email: federico.baronio@aosp.bo.it
- Phone: 00390512144816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.