Status:
COMPLETED
Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour
Lead Sponsor:
Nantes University Hospital
Conditions:
Breast Feeding, Exclusive
Eligibility:
All Genders
1-4 years
Phase:
NA
Brief Summary
Breastfeeding is one of the prime factors of long-term health protection in newborns, for nutritional, immunological and developmental reasons. In France there is a wide inter-regional variability of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01890668
Start Date
July 1 2013
End Date
September 1 2016
Last Update
November 28 2016
Active Locations (1)
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1
Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant
Nantes, France, 44093