Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT06111456
Eligibility Criteria:
Inclusion Criteria:
All populations combined:
* Be a parent or co-parent
* Age of parent:
* woman between 18 and 50 years
* man between 18 and 60 years
* Live in metropolitan France
* Have received information about the SeDeN-p3 Study
* Understand the purpose of the SeDeN-p3 Study
Self-administered questionnaire:
* Be able to read and answer a self-administered questionnaire in French
* Population 1Q:
* Have a child less than a week old
* Have just giver birth in 1 of the partner maternity hospitals during the survey period
* Population 2:
* Parent or co-parent whose youngest child is between 1 week and 3 years old
* Be part of the panel of the selected survey-sample firm
Semi-structured interviews
* Can converse fluently in French
* Accept to conduct a recorded interview
* Population 1E (sub-population of Population 1Q)
* Have completed the entire questionnaire
* Population 3
* Have a child under 5 years old (inclusive) with 1 of the following diseases :
* Phenylketonuria
* Congenital hypothyroidism
* Congenital adrenal hyperplasia
* Cystic fibrosis
* Sickle cell disease
* hearing loss
* MCAD deficiency
* glutaric aciduria type -1
* isovaleric academia
* LCHAD deficiency
* carnitine deficiency
* homocystinuria
* leukinosis
* tyrosinemia type 1
* Population 4
* Have a child under 17 years old (inclusive), with 1 of following diseases:
* Citrullinemia type I
* Ornithine Transcarbamylase Deficiency
* Methylmalonic acidaemia
* Very long-chain acyl-CoA dehydrogenase deficiency
* Carnitine palmitoyl transferase 1 deficiency
* Carnitine palmitoyl transferase 2 deficiency
* Glutaric acidaemia type II
* Galactosaemia
* Biotinidase deficiency
* Pompe Disease
* Mucopolysaccharidosis Type 1
* Glucose-6-phophate dehydrogenase deficiency
* X-linked Adrenoleukodystrophy
* Spinal muscular atrophy linked to SMN1
* S, beta-thalassemia
Exclusion Criteria:
* Have a newborn child die during the recruitment period
* Not speak and/or understand French
* Refuse to participate in the SeDeN-p3 Study
* Be under judicial protection (tutelle, curatelle, habilitation familiale et sauvegarde de justice)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06111456
Study Brief:
Protocol Section:
NCT06111456