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

Completed

• Conditions: Adrenal Hyperplasia, Congenital

• Registration Number: NCT03589144
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-17
• Study Start: 2019-02-11
• Primary Completion: 2020-04-29
• Study Completion: 2020-04-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra-class correlation coefficient between the values of steroids assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term in neonates aged from 48 to 120 hours of life	15 months	Intra-class correlation coefficient between the values of 21 Deoxycortisol (21DF), 17hydroxyprogesterone (17OHP), pregnenolone, 17hydroxypregnenolone and cortisol assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term in neonates aged from 48 to 120 hours of life

Secondary Outcome Measures

Name	Time	Method
Study the difference between the levels of steroids assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term neonates aged from 48 to 120 hours of life according to the presence or not of non-maternal-fetal infection	15 months	Study the difference between the levels 21DF, 17OHP, pregnenolone, 17hydroxypregnenolone and cortisol assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term neonates aged from 48 to 120 hours of life according to the presence or not of non-maternal-fetal infection (chorioamnionitis, neonatal infection at the time of screening)
Study the difference between the levels of steroids assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term neonates according to the term of birth (weeks)	15 months	Study the difference between the levels 21DF, 17OHP, pregnenolone, 17hydroxypregnenolone and cortisol assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term neonates aged from 48 to 120 hours of life according to the term of birth (weeks)
Study the difference between the levels of steroids assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term neonates according to the presence or not of a corticotherapy antenatal.	15 months	Study the difference between the levels 21DF, 17OHP, pregnenolone, 17hydroxypregnenolone and cortisol assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term neonates aged from 48 to 120 hours of life according to the presence or not of a corticotherapy antenatal.
Study the difference between the levels of steroids assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term neonates of life according to the mode of delivery (low or Caesarean section before work)	15 months	Study the difference between the levels 21DF, 17OHP, pregnenolone, 17hydroxypregnenolone and cortisol assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term neonates aged from 48 to 120 hours of life according to the mode of delivery (low or Caesarean section before work)
Study the difference between the levels of steroids assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term neonates aged from 48 to 120 hours of life according to the presence or not of newborn stress.	15 months	Study the difference between the levels 21DF, 17OHP, pregnenolone, 17hydroxypregnenolone and cortisol assayed by LC-MS / MS on dried blood spot and serum of preterm infants and full-term neonates aged from 48 to 120 hours of life according to the presence or not of newborn stress (septic shock and/or hypovolemic shock).

Trial Locations

Locations (1)

Pôle de périnatalité Service de néonatologie; 🇫🇷 Paris, Ile De France, France