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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT05382793
Eligibility Criteria:
Mother-infant pairs in good health, free of any acute illness or chronic thyroid disease.
Mothers
Inclusion criteria:
1. Consent to enroll herself and her baby;
2. Age 18 to 49 years;
3. Singleton pregnancy;
4. Exclusively breastfeeding;
5. Self-estimated BMI \<30 kg/m2 before conception.
Exclusion criteria:
1. TSH \>6 mIU/L;
2. Anemia (Hb \<11.7 g/L);
3. Pregnancy (self-reported);
4. Acute illness (e.g. gastroenteritis);
5. History of thyroid disease, diabetes, metabolic disease or inflammatory bowel disease (self-reported);
6. Currently smoking (\>1 cigarette/day);
7. Drug abuse or extensive alcohol intake;
8. Exposure to iodine-containing X-ray or computed tomography contrast agents during the past 6 months;
9. Adenomatous goiter, dermatitis, anti-C1q-vasculitis.
Infants
Inclusion criteria:
1. Full term (38-42 weeks);
2. Birthweight ≥2.5 kg;
3. Exclusively breastfed;
4. Age 0-10 weeks at recruitment.
Exclusion criteria:
1. Age \>6 months;
2. TSH \>10 mIU/L at neonatal screening at 2-5 days after birth (i.e. infants not requested to attend recall assessment);
3. Diagnosed or suspected colic.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT05382793
Study Brief:
Protocol Section:
NCT05382793