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Can a gentle Hands-On technique help newborns breastfeed?

NCT ID NCT01890668

Symptom relief Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are studying whether early osteopathic manipulative treatment, a gentle hands-on technique, helps healthy newborns with suboptimal breastfeeding behavior. The trial enrolls 128 mother-baby pairs and randomly assigns each newborn to receive the treatment or no treatment, with both groups kept unaware of the assignment. The main goal is to compare breastfeeding failure rates at one month of life, while also tracking feeding scores, maternal satisfaction, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
osteopathic manipulative treatment, a hands-on technique using gentle mobilization
What this could lead to
If it works, this could give parents and clinicians a non-drug option to support early breastfeeding difficulties in healthy newborns.
What could go wrong
This is an early, single-center study of 128 mother-baby pairs, so any benefit may be small or may not hold up in larger, more diverse groups. Osteopathic manipulation is generally gentle, but newborns are fragile and the technique's effects are not well established.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

128 people

The number who actually took part.

Start date

Jul 2013

Finished

Sep 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 4 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Breast Feeding

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast feeding, exclusive

Contacts and locations

Locations

  • Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant

    Nantes, 44093, France

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