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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00306956
Eligibility Criteria:
Inclusion Criteria:
The following patients will be invited to participate before hospital discharge:
* Women who agree not to introduce the pacifier before 2 weeks
* Intention to exclusively breastfeed their infants for at least 3 months
* Breastfeeding exclusively at discharge
* Delivered a healthy singleton newborn
* 37 completed weeks and at least a 2.5 kg birth weight
* Possibility of contact by telephone
* Patients will be randomized at age 15 days if:
* They are exclusively breastfeeding
* They have no existing breastfeeding problems
* Babies use no pacifiers.
* Breastfeeding is well established
* No maternal risk factors for lactation problems
Exclusion Criteria:
* Extremely or persistently sore nipples
* Presence of mastitis or abscess formation.
* Medical situations contraindicating breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Days
Maximum Age:
18 Days
Study:
NCT00306956
Study Brief:
Protocol Section:
NCT00306956