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Clinical Trials/NCT02407860
NCT02407860
Completed
Not Applicable

Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

Université de Sherbrooke1 site in 1 country98 target enrollmentDecember 2014
ConditionsBreastfeeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
Université de Sherbrooke
Enrollment
98
Locations
1
Primary Endpoint
Change from baseline in baby's latch at the breast
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Isabelle Gaboury

Assistant professor

Université de Sherbrooke

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).

Outcomes

Primary Outcomes

Change from baseline in baby's latch at the breast

Time Frame: 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)
  • Change from baseline in devices used to feed the baby(2 and 10 days post-intervention)
  • Change from baseline in mother's nipple pain(Immediately after the intervention and 2, and 10 days post-intervention)
  • Change from baseline in baby's head rotation(Immediately after the intervention)
  • Mother's satisfaction with an osteopathic approach(10 days post-intervention)

Study Sites (1)

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