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Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

NCT ID: NCT02407860

Last Updated: 2015-12-22

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

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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Breastfeeding is the physiological and recommended way of feeding newborns as indicated by the World Health Organization, Health Canada and the politics of perinatality 2008-2018 in Quebec. Despite these, mothers who exclusively breastfed their babies are rare. According to Statistics Canada, the first month of life is the most at risk time to wean because of technical difficulties (53% of weaning) including mechanical issues. In Quebec city, despite a supportive network of health care professionals including lactation consultant, many babies are weaned. Lactation consultant are often feeling helpless when facing these mechanical difficulties.

The purpose of this study is to determine the efficiency of an osteopathic treatment for newborns presenting breastfeeding mechanical difficulties. The investigators' hypotheses is that an osteopathic treatment integrating in the usual care is more efficient than usual car alone to help healing mechanical breastfeeding issues.

The investigators propose a randomized clinical trial on a sample of 90 babies (45 in each group), under six weeks, presenting sucking dysfunctions, in Quebec city (Canada). The control group will receive usual care with a lactation consultant and the intervention group will receive usual care plus an osteopathic treatment. It is a simple blind clinical trial: the osteopath finds out, prior to evaluating the patient, what intervention should be delivered to the baby (assessment alone or standardized osteopathic treatment for infant).

The results will ultimately lead to improvements in the existing knowledge on the fields of osteopathy and lactation support, allowing implementation of osteopathic care in the perinatal network.

Detailed Description

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Conditions

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Breastfeeding

Keywords

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breast feeding sucking dysfunction Latch assessment tool visual analogic scale infant physiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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treatment

one single osteopathic treatment in addition to usual breastfeeding counselling

Group Type EXPERIMENTAL

osteopathic treatment

Intervention Type OTHER

Treatment duration range between 30 to 40 minutes. The infant entire body is evaluated and then manipulative procedures are provided following palpatory results.

control

usual breastfeeding counselling. Osteopathic evaluation of entire body

Group Type ACTIVE_COMPARATOR

usual breastfeeding counselling

Intervention Type OTHER

breastfeeding counselling and support by lactation consultant

Interventions

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osteopathic treatment

Treatment duration range between 30 to 40 minutes. The infant entire body is evaluated and then manipulative procedures are provided following palpatory results.

Intervention Type OTHER

usual breastfeeding counselling

breastfeeding counselling and support by lactation consultant

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy term newborn,
* mechanical suckling dysfunction, assessed by lactation consultant or midwives or healthcare professionals with breastfeeding experience.

Exclusion Criteria

* breastfeeding difficulties from mother (hypogalactia, breast hypoplasia, medication),
* twins or more,
* tongue-tie or lip tie pending for surgical treatment,
* previous or current bodywork (chiropractic, osteopathy, physiotherapy, ergotherapy, craniosacral therapy).
Minimum Eligible Age

48 Hours

Maximum Eligible Age

6 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Isabelle Gaboury

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabelle Gaboury, PhD

Role: STUDY_DIRECTOR

Université de Sherbrooke

Locations

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Entraide Naturo-Lait

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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14-116

Identifier Type: -

Identifier Source: org_study_id