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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02686060
Eligibility Criteria:
Inclusion Criteria:
* Every newborn with a gestational age between 24+0 and 31+6 weeks of gestation or with a birth weight \<1500 gm, born at the maternity of Robert Debré children's hospital,
* Neonates whose parental authority holders have been informed for the study \& do not opposite to participate,
* Neonates whose parental authority holders are covered by the social security system or CMU.
Exclusion Criteria:
* Preterm infants with a gestational age ≥ 32 weeks of gestation,
* Congenital malformation and/or heart diseases other than patent ductus arteriosus or foramen ovale,
* "Outborn" neonates,
* Newborns whose parental authority holders are minor,
* Newborns with severe birth asphyxia (cord blood pH\<7.0 or Apgar score \< 5 at 10 min),
* Newborns whose parental authority holders are not beneficiaries of social security coverage.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
32 Weeks
Study:
NCT02686060
Study Brief:
Protocol Section:
NCT02686060