Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour

NCT01890668 | Completed

• 1 other identifier: RC12_0379
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Feeding, Exclusive

Keywords

Breastfeeding behaviour; OMT (Osteopathic Manipulative Treatment); suboptimal infant breastfeeding behaviour; healthy newborns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Compare IBFAT score (Infant Breast Feeding Assessment Tool score)

  at 10 days of life

• Maternal satisfaction assessment

  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

Study Arms (2)

Osteopathic Manipulative Treatment

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Osteopathic Manipulative Treatment OTHER

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

Osteopathic Manipulative Treatment

No Osteopathic manipulative Treatment OTHER

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

Control group

Eligibility Criteria

• Age: 1 Day - 4 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant

Nantes, 44093, France

Location

Related Publications (1)

• 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.

  PMID: 33789971 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jean-Baptiste MULLER, Doctor

  Centre Hospitalier Universitaire de Nantes, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: July 2, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

FR (1)