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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT03936257
Eligibility Criteria:
Inclusion Criteria:
* 0 to 3 weeks
* Child followed by a general practitioner or pediatrician
* Informed consent form signed by the legal representatives of the subject
* Commitment of legal representatives to follow the constraints generated by the study
* Insured
Exclusion Criteria:
* Infant born prematurely before 37 weeks of amenorrhea
* Child allergic to cow's milk proteins
* Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);
* Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);
* Incapacity for the legal representative(s) to understand or adhere to the protocol
* Subject involved in another clinical study or in an exclusion period from another study
* Legal representatives deprived of liberty
* Legal representatives in a position to judicial protection
* Weight of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
* Subject height according to age and sex, not between the 3rd and the 97th percentile of the WHO Child Growth Standards
* BMI of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
* Head circumference of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO (World Health Organization) Child Growth Standards
* The investigator considers that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
21 Days
Study:
NCT03936257
Study Brief:
Protocol Section:
NCT03936257