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Completed

NCT Number: NCT02407860

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.

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Key information

Age range

48 hour–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Entraide Naturo-Lait

Québec, Quebec, G1S 3S5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Osteopathic Treatment

Other

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

Other

breastfeeding counselling and support by lactation consultant

Primary outcomes

  1. 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

  1. Change from baseline in numbers of feeds per day

    Time frame: Immediately after the intervention and 2, and 10 days post-intervention

    Home made questionnaire with close-ended questions

  2. Change from baseline in devices used to feed the baby

    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.

  3. Change from baseline in mother's nipple pain

    Time frame: Immediately after the intervention and 2, and 10 days post-intervention

    Visual analog scale from 0 (no pain) to 10 (extreme pain)

  4. Change from baseline in baby's head rotation

    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

  5. Mother's satisfaction with an osteopathic approach

    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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2015
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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