Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

Breastfeeding Clinical Trial

Official title:

Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407860
• Other study ID #: 14-116
• Status: Completed
• Phase: N/A
• First received: March 10, 2015
• Last updated: December 21, 2015
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministère santé et services sociaux du Québec
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• 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.
• usual breastfeeding counselling
breastfeeding counselling and support by lactation consultant

Locations

Country	Name	City	State
Canada	Entraide Naturo-Lait	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in baby's latch at the breast	Latch assessment tool (Jensen, Wallace & Kelsay; 1994)	Immediately after the intervention and 2 days post-intervention	No
Secondary	Change from baseline in numbers of feeds per day	Home made questionnaire with close-ended questions	Immediately after the intervention and 2, and 10 days post-intervention	No
Secondary	Change from baseline in devices used to feed the baby	Home made questionnaire with open-ended and close-ended questions, including the number of bottles the day before.	2 and 10 days post-intervention	No
Secondary	Change from baseline in mother's nipple pain	Visual analog scale from 0 (no pain) to 10 (extreme pain)	Immediately after the intervention and 2, and 10 days post-intervention	No
Secondary	Change from baseline in baby's head rotation	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	Immediately after the intervention	No
Secondary	Mother's satisfaction with an osteopathic approach	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	10 days post-intervention	No