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

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

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-11

Study Completion Date

2020-04-29

Brief Summary

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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

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Conditions

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Adrenal Hyperplasia, Congenital

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

48 Hours

Maximum Eligible Age

120 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pôle de périnatalité Service de néonatologie

Paris, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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NI17050J

Identifier Type: -

Identifier Source: org_study_id