Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour (NEOSTEO)

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.

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.

Study Overview

• Status: Completed
• Conditions: Breast Feeding, Exclusive
• Intervention / Treatment: Other: Osteopathic Manipulative Treatment; Other: No Osteopathic manipulative Treatment

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 days (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Osteopathic Manipulative Treatment; Randomization and first OMT will take place at discharge (Day 3); second osteopathic therapy will be performed by the same osteopath practitioner at Day10.	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
PLACEBO_COMPARATOR: Control group; Control group consists in classical medical and paramedical breastfeeding support. OMT on the newborn will be realized by osteopath dissimulated behind a screen. Placebo OMT consists to mimic, without the knowledge of parents, osteopathic techniques on a dolly.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Maternal satisfaction assessment	assessment of maternal satisfaction between the Cs1, Cs2 and the visit at one month, by VAS	at one month of life
Safety assessment measured by per-treatment DAN score		at 3 days of life
Preventive efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks		at one month of life
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
Description of breastfeeding initiation during the first month of life.		at one month of life
Assessment of differential efficacy according osteopathic practitioner profile (age/experience, perinatal specialization…)		at 10 days of life
Description of osteopathic dysfunctions frequencies diagnosed by osteopath.		at 10 days of life
Safety assessment measured by per-treatment DAN score		at 10 days of life
Curative efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks		at one month of life

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Jean-Baptiste MULLER, Doctor, Centre Hospitalier Universitaire de Nantes, France

Publications and helpful links

General Publications

• Danielo Jouhier M, Boscher C, Roze JC, Cailleau N, Chaligne F, Legrand A, Flamant C, Muller JB; NEOSTEO osteopath study group. Osteopathic manipulative treatment to improve exclusive breast feeding at 1 month. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):591-595. doi: 10.1136/archdischild-2020-319219. Epub 2021 Mar 31.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: June 21, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (ESTIMATE): July 2, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 25, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Breastfeeding behaviour; OMT (Osteopathic Manipulative Treatment); suboptimal infant breastfeeding behaviour; healthy newborns
• Other Study ID Numbers: RC12_0379