Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

NCT02407860 — Not applicable, Completed, 98 participants, Université de Sherbrooke

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Registry	NCT02407860
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	98 (Actual)
Sponsor	Université de Sherbrooke (Other)
Conditions	Breastfeeding
Interventions	osteopathic treatment, usual breastfeeding counselling (Other)
Dates	start 2014-12-01, primary completion 2015-12-01, completion 2015-12-01, first posted 2015-04-03, last updated 2015-12-22
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
treatment	Experimental	Other: osteopathic treatment	one single osteopathic treatment in addition to usual breastfeeding counselling
control	Active comparator	Other: usual breastfeeding counselling	usual breastfeeding counselling. Osteopathic evaluation of entire body

osteopathic treatment (Other): Treatment duration range between 30 to 40 minutes. The infant entire body is evaluated and then manipulative procedures are provided following palpatory results.
usual breastfeeding counselling (Other): breastfeeding counselling and support by lactation consultant

+Outcome measures

Primary outcomes

Change from baseline in baby's latch at the breast [Immediately after the intervention and 2 days post-intervention]: Latch assessment tool (Jensen, Wallace \& Kelsay; 1994)

Secondary outcomes

Change from baseline in numbers of feeds per day [Immediately after the intervention and 2, and 10 days post-intervention]: Home made questionnaire with close-ended questions
Change from baseline in devices used to feed the baby [2 and 10 days post-intervention]: Home made questionnaire with open-ended and close-ended questions, including the number of bottles the day before.
Change from baseline in mother's nipple pain [Immediately after the intervention and 2, and 10 days post-intervention]: Visual analog scale from 0 (no pain) to 10 (extreme pain)
Change from baseline in baby's head rotation [Immediately after the intervention]: Assessment 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 approach [10 days post-intervention]: Likert scale to assess the mother's perception of an osteopathic approach with four items: not at all satisfied, somewhat satisfied, satisfied and very satisfied

+Eligibility

Sex: All, ages: 48 Hours to 6 Weeks, accepts healthy volunteers

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).

+Locations (1)

Facility	City	Country	Status
Entraide Naturo-Lait	Québec, Quebec	Canada

+Investigators

Isabelle Gaboury, PhD, Study director, Université de Sherbrooke