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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT03111927
Eligibility Criteria:
Inclusion Criteria:
* Term infants (≥ 37 weeks)
* Neuro typical development
* No major risk factors for learning, neurologic, or psychiatric disorder
* Between 2 weeks and maximum 5 weeks of age. If mother is breastfeeding she can choose the infant begin the trial prior 2 weeks.
* Parents/legal guardians willing and able to complete the informed consent process
Exclusion Criteria:
* Delayed birth (\> 41 weeks gestation)
* Birth Weight \< 2000 g or small for gestation age or large for gestational age
* Psychopharmacological treatment of mother using prohibited medications during pregnancy
* In utero exposure to alcohol abuse or illicit substances as per the American College of Obstetricians and Gynecologists
* Abnormalities on fetal ultrasound
* Complicated pregnancy
* Neonatal intensive care unit admission and/or emergency surgical delivery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Weeks
Maximum Age:
6 Weeks
Study:
NCT03111927
Study Brief:
Protocol Section:
NCT03111927