Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Other: osteopathic treatment; Other: usual breastfeeding counselling

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1S 3S5
    • Entraide Naturo-Lait

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; one single osteopathic treatment in addition to usual breastfeeding counselling	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.
Active Comparator: control; usual breastfeeding counselling. Osteopathic evaluation of entire body	Other: usual breastfeeding counselling; breastfeeding counselling and support by lactation consultant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Study Director: Isabelle Gaboury, PhD, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 10, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: dysfunction; breast feeding; sucking; Latch assessment tool; visual analogic scale; infant physiology
• Other Study ID Numbers: 14-116