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 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT02314494
Eligibility Criteria:
Inclusion Criteria:
* Parents/legal guardians/carers of infants aged 6-8 weeks
* First or subsequent born infants
Exclusion Criteria:
* Parents/legal guardians/carers of infants with known medical conditions requiring special diets
* Mothers who have a diagnosis of post-natal depression (PND) or who score moderate PND or above on health visitor applied screening tools (EPDS \>13) (PHQ-9 \>10) or anxiety (GAD-7 score \>10)
* Infants born \<32 weeks gestation
* Infants born 32-40 weeks whose birth weight is less than 2nd centile
* Infants born at term (40 weeks) who weigh less than 2.5 kg
* Parents/legal guardians/carers who lack sufficient command of English to complete questionnaires where no face to face translation is available
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
12 Weeks
Study:
NCT02314494
Study Brief:
Protocol Section:
NCT02314494