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Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02407860
Enrollment
98
Registered
2015-04-03
Start date
2014-12-31
Completion date
2015-12-31
Last updated
2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

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

Brief summary

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.

Interventions

OTHERusual breastfeeding counselling

breastfeeding counselling and support by lactation consultant

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

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
48 Hours to 6 Weeks
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in baby's latch at the breastImmediately after the intervention and 2 days post-interventionLatch assessment tool (Jensen, Wallace & Kelsay; 1994)

Secondary

MeasureTime frameDescription
Change from baseline in numbers of feeds per dayImmediately after the intervention and 2, and 10 days post-interventionHome made questionnaire with close-ended questions
Change from baseline in devices used to feed the baby2 and 10 days post-interventionHome made questionnaire with open-ended and close-ended questions, including the number of bottles the day before.
Change from baseline in mother's nipple painImmediately after the intervention and 2, and 10 days post-interventionVisual analog scale from 0 (no pain) to 10 (extreme pain)
Change from baseline in baby's head rotationImmediately after the interventionAssessment of baby's ability to rotate his/her head on left and right compared to a baseline evaluation prior to the intervention, using a goniometer
Mother's satisfaction with an osteopathic approach10 days post-interventionLikert scale to assess the mother's perception of an osteopathic approach with four items: not at all satisfied, somewhat satisfied, satisfied and very satisfied

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026