Entraide Naturo-Lait
Québec, Quebec, G1S 3S5, Canada
NCT Number: NCT02407860
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.
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Notify Me48 hour–6 week
All sexes
Interventional
Not applicable
Québec, Quebec, G1S 3S5, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment duration range between 30 to 40 minutes. The infant entire body is evaluated and then manipulative procedures are provided following palpatory results.
breastfeeding counselling and support by lactation consultant
Time frame: Immediately after the intervention and 2 days post-intervention
Latch assessment tool (Jensen, Wallace & Kelsay; 1994)
Time frame: Immediately after the intervention and 2, and 10 days post-intervention
Home made questionnaire with close-ended questions
Time frame: 2 and 10 days post-intervention
Home made questionnaire with open-ended and close-ended questions, including the number of bottles the day before.
Time frame: Immediately after the intervention and 2, and 10 days post-intervention
Visual analog scale from 0 (no pain) to 10 (extreme pain)
Time frame: 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
Time frame: 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
Université de Sherbrooke
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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