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 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT01890668
Eligibility Criteria:
Inclusion Criteria:
* Healthy newborn ≥ 38 weeks of gestation,
* Suboptimal breastfeeding behavior defined by an IBFATmax score \<10 after 2 assessments.(IBFATmax score = maximal score of Infant Breast Feeding Assessment Tool)
* And/ or presence of persistent severe pain (VAS\> 5) at hospital discharge,
* And / or the presence of nipples cracks, grades 2-5 on the NTS scale
* Maternal Project of exclusive breastfeeding.
* Parental informed and consent form signed
Exclusion Criteria:
* Prematurity defined by a gestation \<38 weeks
* Hypotrophy
* Maternal obesity (BMI\>40)
* Multiple pregnancy
* Congenital malformation
* Neonatal pathology incompatible with efficient lactation initiation.
* Mothers minor or major and / or under guardianship and / or with poor understanding of French language
* Previous history of maternal breast surgery or umbilicated nipple
* IBFAT score max \>10 on at least one of the two assessment at Day3.
* Medical contraindication to osteopathy: bone injury (fracture), tendon or ligament (sprain, dislocation etc ...) in the newborn incompatible with effective mobilization.
* Parental consent withdrawal.
* Neonatal pathology incompatible with breastfeeding follow-up in the first month of life.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
4 Days
Study:
NCT01890668
Study Brief:
Protocol Section:
NCT01890668