Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour

Breast Feeding, Exclusive Clinical Trial

— NEOSTEO  

Official title:

Efficacy Assessment of Early Osteopathic Manipulative Treatment (OMT) in the Management of Suboptimal Breastfeeding Behaviour in Healthy Newborns. A Prospective Monocentric Randomized Double-blinded Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890668
• Other study ID #: RC12_0379
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: November 25, 2016
• Start date: July 2013
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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 breastfeeding rates at discharge. This variability associates different factors involving both, mothers, birth conditions, newborns and mother-child couple. Some approaches, including osteopathy, aim to support early breastfeeding difficulties. As many others non-conventional medicines, there is a huge and growing interest for this alternative therapy and a spontaneous recourse in the first months of life. Nevertheless, neither efficacy nor the benefits have been studied. Thus, our objective is to evaluate for the first time in France, in a randomized, double-blinded design, the efficacy of early osteopathic manipulative treatment (OMT), in suboptimal breastfeeding behaviour healthy newborns.

128 couples mother-child will be randomized in two groups: with or without osteopathic intervention on the newborn.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Feeding, Exclusive

Intervention

Other:
• Osteopathic Manipulative Treatment
Visit 1 between H60 and discharge : Interview (pregnancy step, initiation of breastfeeding, baby posture…) Osteopathic Clinical exam (osteopathic specific diagnosis, mobility…) Osteopathic Manipulative Treatment by sweet osteopathic mobilization Time of intervention = 30 to 45 min Visit 2 : 7 days after visit 1 (+/- 24H) with the same procedure To keep the blinded procedure the interventions will be realized behind a screen, allowing interactions with parents but depriving their visibility. A telephone contact will be perform at M1 (one month of life) to assess breastfeeding persistence and collect questionnaire data. Two others telephone contacts will be perform at 3 months and 6 months to precise breastfeeding interruption date. The follow-up for each patient is 6 months
• No Osteopathic manipulative Treatment
Visit 1 between H60 and discharge : Interview (pregnancy steps, initiation of breastfeeding, baby posture…) Osteopathic Clinical exam and Treatment will not be realized. Newborn will be undressed, lying naked (covered with polar sheet) on the exam table, dissimulated to parents by adequate screen. The osteopathic procedure will take place on a dolly to mimic from an indiscernible manner, osteopathic management. Time of intervention = 30 to 45 min Visit 2: 7 days after visit 1 (+/- 24H) with the same procedure. To keep the blinded procedure the interventions will be realized behind a screen, allowing interactions with parents but depriving their visibility. A telephone contact will be perform at M1 (one month of life) to assess breastfeeding persistence and collect questionnaire data. Two others telephone contacts will be perform at 3 months and 6 months to precise breastfeeding interruption date. The follow-up for each patient is 6 months

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life.	compare of breastfeeding failure percentage at one month of life between the two arms	at 1 month of life.	No
Secondary	Compare IBFAT score (Infant Breast Feeding Assessment Tool score)	compare the IBFAT score between the two consultation Cs1(day 3) and Cs2 (day 10)	at 10 days of life	No
Secondary	Maternal satisfaction assessment	assessment of maternal satisfaction between the Cs1, Cs2 and the visit at one month, by VAS	at one month of life	No
Secondary	Safety assessment measured by per-treatment DAN score		at 3 days of life	Yes
Secondary	Preventive efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks		at one month of life	No
Secondary	Description of newborns behaviour during the first month of life (sleeping/awakening rhythm, cries and breastfeeding durations etc…) according treatment arm.		at one month of life	No
Secondary	Description of breastfeeding initiation during the first month of life.		at one month of life	No
Secondary	Assessment of differential efficacy according osteopathic practitioner profile (age/experience, perinatal specialization…)		at 10 days of life	No
Secondary	Description of osteopathic dysfunctions frequencies diagnosed by osteopath.		at 10 days of life	No
Secondary	Safety assessment measured by per-treatment DAN score		at 10 days of life	Yes
Secondary	Curative efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks		at one month of life	No