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临床试验/NCT02407860
NCT02407860已完成不适用

Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
2
主要终点
Change from baseline in baby's latch at the breast

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
48 Hours 至 6 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • healthy term newborn,
  • mechanical suckling dysfunction, assessed by lactation consultant or midwives or healthcare professionals with breastfeeding experience.

排除标准

  • 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).

结局指标

主要结局

Change from baseline in baby's latch at the breast

时间窗: Immediately after the intervention and 2 days post-intervention

Latch assessment tool (Jensen, Wallace \& Kelsay; 1994)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabelle Gaboury

Assistant professor

Université de Sherbrooke

研究点 (2)

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