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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT03553134
Eligibility Criteria:
Inclusion Criteria:
* Written consent of parent
* Newborns over 35 weeks of amenorrhoea hospitalized in the maternity ward
Exclusion Criteria:
* person not affiliated to a health insurance scheme
* Sepsis
* Ductal dependent heart disease
* Neurological impairment (anoxoischemic encephalopathy Sarnat\>1, pH\<7 and/or lactates\>11, meningitis)
* Obstetrical trauma (instrumental delivery by forceps, vacuum cup or spatulas)
* Potentially lethal malformation
* Anemia (hemoglobin\<14g/dl)
* Polyglobulia (hemoglobin\>22g/dl)
* Small for gestational age (weight\<10th percentile)
* Large for gestational age (weight\>97th percentile)
* Proven gestational diabetes (non-insulin-dependent and insulin-dependent)
* Maternal medical treatment (cardiac or anti-epileptic)
* Inadequate parent understanding
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
6 Hours
Study:
NCT03553134
Study Brief:
Protocol Section:
NCT03553134