Clinical trial NCT02407860: Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn
Official title: Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: breast feeding
sucking
dysfunction
Latch assessment tool
visual analogic scale
infant physiology
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 98
Sex: ALL
Minimum age (years): 48
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline in baby's latch at the breast
timeFrame: Immediately after the intervention and 2 days post-intervention
Secondary outcomes:
measure: Change from baseline in numbers of feeds per day
timeFrame: Immediately after the intervention and 2, and 10 days post-intervention
measure: Change from baseline in devices used to feed the baby
timeFrame: 2 and 10 days post-intervention
measure: Change from baseline in mother's nipple pain
timeFrame: Immediately after the intervention and 2, and 10 days post-intervention
measure: Change from baseline in baby's head rotation
timeFrame: Immediately after the intervention
measure: Mother's satisfaction with an osteopathic approach
timeFrame: 10 days post-intervention
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Entraide Naturo-Lait
Study officials:
affiliation: Université de Sherbrooke
name: Isabelle Gaboury, PhD
role: STUDY_DIRECTOR
References: