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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03981133
Eligibility Criteria:
Inclusion Criteria
* Understands the benefits and risk for offer liberally the pacifier during their stay at the maternity.
* Expressed an intention to breast feed exclusively their infant for at least 3 -months
* Possibility of contact by telephone
* Has the decision to offer a pacifier to the newborn infant , but not definite opinion about when are going to offer a pacifier
* Primiparous single birth
* Mother´s age 18 years or more
Exclusion Criteria:
* Maternal risk factors for lactation
* Lack of noticeable breast enlargement during pregnancy
* Flat or inverted nipples
* Variation in breast appearance (marked asymmetry, hypoplastic, tubular)
* Any previous breast surgery, including plastics procedure
* Psychosocial problems (eg, depression, poor or negative support of breastfeeding
* Mother with a chronic condition that could influence development , including feeding ability
* Mother with eating or mental disorder.
* Mothers who smoke during pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Hours
Maximum Age:
3 Days
Study:
NCT03981133
Study Brief:
Protocol Section:
NCT03981133