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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Adrenal Hyperplasia, Congenital

Study type: Observational

Funder types: Other

Identifiers

NCT03589144

NI17050J

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 48 to 120 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 48 and 120 hours of life.
• Term of gestation: 30 to 41 weeks of gestation + 6 days
• weight at inclusion ≥ 1000 g
• non-opposition of the holders of parental authority

Exclusion criteria

• Patient who already had neonatal screening prior to inclusion.
• Patients whose health status contraindicates additional blood collection at the time of neonatal screening.
• Inability to give legal representatives of newborns informed information
• Minor Parents