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Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

U

Université de Sherbrooke

Status

Completed

Conditions

Breastfeeding

Treatments

Other: osteopathic treatment
Other: usual breastfeeding counselling

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

All

Ages

48 hours to 6 weeks old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

98 participants in 2 patient groups

treatment
Experimental group
Description:
one single osteopathic treatment in addition to usual breastfeeding counselling
Treatment:
Other: osteopathic treatment
control
Active Comparator group
Description:
usual breastfeeding counselling. Osteopathic evaluation of entire body
Treatment:
Other: usual breastfeeding counselling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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