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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT02608151
Eligibility Criteria:
Inclusion Criteria:
* Children whose term of birth is between 26 and 31 weeks of amennorhea
* Children's age less than or equal to 33 weeks of postnatal age
* Children without neurological pathologies (intra ventricular hemorrhage grade 1 or 2 of the papilla transfontanellar ultrasound \[Papille 1978\] and / or brain abnormalities on MRI type of 1-4 according to modified Paneth classification \[Paneth 1999\]);
* Children whose parenteral nutrition is less than 60 cc / kg / day;
* Children without infectious disease clinically unstable ( C reactive protein below 7);
* Children without CPAP (Positive Airway Pressure Control) nasal for at least 48 hours;
* Children do not present a genetic syndrome, progressive neurological disease, malformation pathology, a cleft lip and palate;
* Children with one parent or legal representatives are beneficiaries of a social security regimen;
Exclusion Criteria:
* Children under 26 and more than 32 weeks of amenorrhea;
* Children not included at 34 weeks of amenorrhea;
* Children with high-grade intraventricular hemorhage (grade 3-4) \[Papille 1978\] and / or abnormality of cerebral MRI (grade 5 and 6) \[Paneth 1999\];
* Children with a necrotizing enterocolitis or nosocomial infection;
* Children with a genetic syndrome, a progressive neurological disease, malformation pathology, a cleft lip and palate.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
33 Weeks
Study:
NCT02608151
Study Brief:
Protocol Section:
NCT02608151