Breast Feeding, ExclusiveNEOSTEONCT01890668
Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour
A study testing Osteopathic Manipulative Treatment and No Osteopathic manipulative Treatment in people with Breast Feeding, Exclusive, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 4 days
- Conditions the study is for
- Breast Feeding, Exclusive
- What is being tested?
- Osteopathic Manipulative Treatment and No Osteopathic manipulative Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 4 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Prematurity defined by a gestation <38 weeks
- Hypotrophy
- Maternal obesity (BMI>40)
- Multiple pregnancy
- Congenital malformation
- Neonatal pathology incompatible with efficient lactation initiation.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant
Nantes, 44093
About this study
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.
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
- Being tested
- Osteopathic Manipulative Treatment, No Osteopathic manipulative Treatment
- Keywords
- Breastfeeding behaviour, OMT (Osteopathic Manipulative Treatment), suboptimal infant breastfeeding behaviour, healthy newborns
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
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 TreatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No Osteopathic manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 1 month of life.
Secondary outcomes (10)
Compare IBFAT score (Infant Breast Feeding Assessment Tool score)
compare the IBFAT score between the two consultation Cs1(day 3) and Cs2 (day 10)
Measured: at 10 days of life
Maternal satisfaction assessment
assessment of maternal satisfaction between the Cs1, Cs2 and the visit at one month, by VAS
Measured: at one month of life
Safety assessment measured by per-treatment DAN score
Measured: at 3 days of life
Preventive efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks
Measured: 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.
Measured: at one month of life
Description of breastfeeding initiation during the first month of life.
Measured: at one month of life
Assessment of differential efficacy according osteopathic practitioner profile (age/experience, perinatal specialization…)
Measured: at 10 days of life
Description of osteopathic dysfunctions frequencies diagnosed by osteopath.
Measured: at 10 days of life
Safety assessment measured by per-treatment DAN score
Measured: at 10 days of life
Curative efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks
Measured: at one month of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Feeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste MULLER, Doctor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890668
- Sponsor's protocol ID
- RC12_0379
- Acronym
- NEOSTEO
- Status last verified
- Nov 2016
- First submitted
- 21 Jun 2013
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33789971
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01890668
- Acronym / sponsor ID
- NEOSTEO / RC12_0379
- Conditions
- Breast Feeding, Exclusive
- Keywords
- Breastfeeding behaviour, OMT (Osteopathic Manipulative Treatment), suboptimal infant breastfeeding behaviour, healthy newborns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Other: Osteopathic Manipulative TreatmentRandomization and first OMT will take place at discharge (Day 3); second osteopathic therapy will be performed by the same osteopath practitioner at Day10. |
| Control group | Placebo comparator | Other: No Osteopathic manipulative TreatmentControl 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. |
Who may qualify
- Ages
- 1 day to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- Prematurity defined by a gestation <38 weeks
- Hypotrophy
- Maternal obesity (BMI>40)
- Multiple pregnancy
- Congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentVisit 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 | Other | Osteopathic Manipulative Treatment |
| No Osteopathic manipulative TreatmentVisit 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 | Other | Control group |
Primary outcome
Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life.
Time frame: at 1 month of life.
compare of breastfeeding failure percentage at one month of life between the two arms
10 secondary outcomes
Compare IBFAT score (Infant Breast Feeding Assessment Tool score)
Time frame: at 10 days of life
Maternal satisfaction assessment
Time frame: at one month of life
Safety assessment measured by per-treatment DAN score
Time frame: at 3 days of life
Preventive efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks
Time frame: 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.
Time frame: at one month of life
Description of breastfeeding initiation during the first month of life.
Time frame: at one month of life
Assessment of differential efficacy according osteopathic practitioner profile (age/experience, perinatal specialization…)
Time frame: at 10 days of life
Description of osteopathic dysfunctions frequencies diagnosed by osteopath.
Time frame: at 10 days of life
Safety assessment measured by per-treatment DAN score
Time frame: at 10 days of life
Curative efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks
Time frame: at one month of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 33789971Danielo 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.
Related trials for Breast Feeding, Exclusive
Not yet recruiting
Effect of a Breastfeeding Chatbot on Mothers' Breastfeeding Attitudes, Behaviors, and Self-Efficacy
Breastfeeding, Breastfeeding Attitudes
Not yet recruiting
Healthy Habits During and After Gestational Diabetes
GDM
Recruiting
Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center
Growth & Development, Breastfeeding Satisfaction
RecruitingObservational study
Evaluation of a Health Mediation Program in the Maternity Ward.
Breast Feeding, Exclusive
Recruiting
Hybrid Breastfeeding Education in Late Pregnancy: Effects on Antenatal Attachment and Breastfeeding
Breast Feeding, Exclusive Breast Feeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Baptiste MULLER, Doctor principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment and No Osteopathic manipulative Treatment in people with Breast Feeding, Exclusive, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life. (time frame: at 1 month of life.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01890668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.