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:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT01566058
Eligibility Criteria:
Inclusion Criteria:
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow up
* The patient has given birth this day to a premature child (\< 36 weeks of gestation and/or \< 2 kg birthweight)
* Separation of child and mother since birth
Exclusion Criteria:
* The patient or baby is participating in another study, excepting the studies "OASIS" or "PROM8736"
* The patient or baby is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient or father refuses to sign the consent
* It is impossible to correctly inform the patient
* Preexisting maternal psychiatric pathology
* Major or lethal poly-malformation syndrome
* Severe pathologies that threaten child survival: pulmonary hypertension, septic shock, anoxic-ischemic brain
* Any emergency situation preventing patient involvement
* Mother and/or child not hospitalized at the Nîmes University Hospital
* Death of the patient or child during the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01566058
Study Brief:
Protocol Section:
NCT01566058