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Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour

NCT ID: NCT01890668

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Feeding, Exclusive

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Osteopathic Manipulative Treatment

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

No Osteopathic manipulative Treatment

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

4 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Baptiste MULLER, Doctor

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nantes, France

Locations

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Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant

Nantes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33789971 (View on PubMed)

Other Identifiers

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RC12_0379

Identifier Type: -

Identifier Source: org_study_id