Clinical Trials Directory

Trials / Completed

CompletedNCT03589144

LC-MS / MS Adrenal Steroids Assayed on Dried Blot Spot for the Congenital Adrenal Hyperplasia Neonatal Screening (SPECTROSPOT)

LC-MS / MS Adrenal Steroids Assayed on Dried Blot Spot for the Congenital Adrenal Hyperplasia Neonatal Screening: a Pilot, Multicenter, Prospective Study

Status
Completed
Phase
Study type
Observational
Enrollment
132 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
48 Hours – 120 Hours
Healthy volunteers
Not accepted

Summary

This research uses the Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS / MS) technique on dried blot spot samples for the neonatal screening of congenital adrenal hyperplasia. The main objective of this study is to demonstrate that this technique allow dosage of adrenal steroids on dried blot spot samples as efficiently and with the same sensitivity than the current technic on a cohort of 132 newborns aged 2 to 5 days, with a gestational age greater than or equal to 30 weeks of amenorrhea.

Conditions

Timeline

Start date
2019-02-11
Primary completion
2020-04-29
Completion
2020-04-29
First posted
2018-07-17
Last updated
2021-10-28

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03589144. Inclusion in this directory is not an endorsement.