Status:

COMPLETED

Fast Exome for Diagnosis of Congenital Conditions in Infants Under 12 Months of Age Hospitalized in Intensive Care Unit

Lead Sponsor:

University Hospital, Montpellier

Conditions:

Infant, Newborn, Diseases

Congenital Malformations

Eligibility:

All Genders

1-12 years

Brief Summary

An early diagnosis of congenital malformations and suspected genetic conditions in critically ill infants is essential to perform specific adapted care, prevention, and give proper genetic counseling....

Detailed Description

This prospective study is the first French study aiming to evaluate the feasibility of fast trio exome sequencing (less than 16 days between informed consent signature and consultation for results pre...

Eligibility Criteria

Inclusion

  • Infant aged under 12 months , hospitalized in the ICU.
  • Infant with multiple congenital malformations or neurological symptoms for which a genetic origin is suspected but undiagnosed genetically.
  • Infant for whom both biological parents have given consent for the study, genetic analysis for themselves anf their child.
  • Infant and parents registered in the French National health service

Exclusion

  • Absence of one or both parental sample.
  • Precise genetic diagnosis made pre- or post-natally with chromosomal (I.e : Down syndrome), Sanger (i.e : infantile spinal amyotrophia) methylation (i.e : Prader-Willi syndrome) or triplet amplification (I.e : neonatal Steinert myotonia) studies.
  • Strong clinical evidence for a with chromosomal (I.e : Down syndrome), Sanger (i.e : infantile spinal amyotrophia) methylation (i.e : Prader-Willi syndrome) or triplet amplification (I.e : neonatal Steinert myotonia) studies.
  • Impossibility for one or both parents to give his or her consent

Key Trial Info

Start Date :

April 8 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 8 2022

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT03831035

Start Date

April 8 2019

End Date

June 8 2022

Last Update

November 28 2023

Active Locations (1)

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1

Medical genetics Arnaud de Villeneuve

Montpellier, Hérault, France, 34295