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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT00607061
Eligibility Criteria:
Inclusion Criteria (first step):
* Full term newborn babies
* Gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile
* Eutocic delivery
Inclusion Criteria (second step):
* Low birth weight newborn babies (gestational age \< 32 weeks of amenorrhea and/or weight of birth \< 1500 g and/or weight of birth \< third percentile for their gestational age)
* Full term newborn babies (gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile)
Exclusion criteria (first and second step):
* Mother diastolic blood pressure \> 90 mmHg during pregnancy,
* pH \< 7.2 at umbilical cord and/or difference in pH \< 0,02 between arterial pH and venous pH
* Dystocic delivery
* Bacterial or viral maternofoetal infection
* Foetal malformation
* Foetal disease
* Taking N-acetyl-cystein or vitamines and antioxidant minerals by the mother for the last 24 hours
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
9 Months
Study:
NCT00607061
Study Brief:
Protocol Section:
NCT00607061