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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT03143504
Eligibility Criteria:
Inclusion Criteria:
Mothers 1) ≥18 years old 2) Carrying singleton pregnancies that are booked in to give birth at The Jessop maternity wing (Sheffield Teaching Hospitals NHS Foundation Trust) 3) Live within a 5 mile radius of The University of Sheffield
Babies:
4\) Healthy, full-term babies (≥37 weeks gestation) ≤72 hours old
Exclusion Criteria:
Mothers:
1. \<18 years old
2. Known to be carrying a baby with a chromosomal abnormality or other syndromic diagnosis
3. Unable to satisfactory give informed consent for participation
4. Multiple pregnancies
5. Live greater than 5 miles from The University of Sheffield
Babies:
6. Admission to neonatal unit
7. Major congenital malformations or limb defects
8. Illness, social issues or logistical reason that at the discretion of the direct care team, will prevent comfortable trial participation by the family
9. The baby is to be adopted
10. Currently participating in an interventional clinical trial that interferes with the STAR study objectives
11. \>72 hours old -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
37 Weeks
Maximum Age:
13 Months
Study:
NCT03143504
Study Brief:
Protocol Section:
NCT03143504