Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

Not Applicable

Completed

• Conditions: Breastfeeding
• Interventions: Other: osteopathic treatment; Other: usual breastfeeding counselling

• Registration Number: NCT02407860
• Lead Sponsor: Université de Sherbrooke

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment	osteopathic treatment	one single osteopathic treatment in addition to usual breastfeeding counselling
control	usual breastfeeding counselling	usual breastfeeding counselling. Osteopathic evaluation of entire body

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Entraide Naturo-Lait; 🇨🇦 Quebec, Canada