跳至主要内容
临床试验/NCT03681782
NCT03681782终止不适用

Evaluation of the Risks and Benefits of Abdominal Massage Treatment in Neonatalogy in Premature Children

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
1
主要终点
Change in the neonatal infant pain score

研究概览

简要总结

Premature birth creates difficulties for the child in starting his diet and digestion. The immaturity of the major vital functions complicates the abdominal transit. The initial diet, essentially parenteral in the central way, decreases progressively according to the digestive tolerance allowing the increase of the enteral feedings to optimize the growth. To ensure this transition, nurses nurses in Neonatology service, through their knowledge and expertise, practice a daily gesture: abdominal massage-care. This prevents or remedies a slowing of transit. The paramedical clinical examination of the child, determines the realization of this care. Several studies have proved the benefit of massage on the weight gain of premature babies. These stimulate peristalsis, decrease the duration of intestinal transit and the sensations of discomfort and pain related to it. Currently in Neonatology, developmental care (NIDCAP) is an approach to individualized care for the premature to improve its evolution. The fine observation of his behavior allows us to adapt our care and to ensure the respect of his pace. However, the first sensory capacity developed in the fetus, the touch can also be a source of over-stimulation for the premature baby. Moreover, the greater the prematurity, the greater the risk of occurrence of digestive complications. Can the abdominal care-massage in premature babies be harmful or risk increasing existing symptoms? The abdominal care-massage is neither described nor referenced in the nomenclature of nursing, neither taught nor subject to medical prescription.

Few publications exist on this subject, no large-scale research has been reported. On the other hand, the perception of our empirical practice seems to show that the abdominal massage-care is an important aid to the smooth transit of the premature newborn. Transmitted orally by professionals to newcomers to Neonatology, this treatment is carried out in a heterogeneous manner according to professionals. Convinced of its effectiveness, carers wonder about their practice: is there an optimal technique without risk for the child? Determining the absence of risk and the effectiveness of the abdominal care-massage suggests a wider benefit for the well-being and progress of the premature child until he leaves the hospital. This validated practice could be disseminated on a larger scale in other neonatal departments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Children born before 37 weeks of amenorrhea hospitalized in the neonatology department

排除标准

  • children with a malformation or a digestive pathology with or without surgery
  • medical prescription of non-massage care
  • children born under the secret

结局指标

主要结局

Change in the neonatal infant pain score

时间窗: up to 30 days from baseline

neonatal infant pain scale (EDIN)) (\>4 or\>=4)

arterail oxygenation desaturation

时间窗: up to 30 days from baseline

arterail oxygenation desaturation (yes/no)

bradycardia

时间窗: up to 30 days from baseline

bradycardia (yes/no)

Significant adverse effects

时间窗: up to 30 days from baseline

volvulus of the small intestine, intestinal perforation

Change in the abdominal aspect

时间窗: up to 30 days from baseline

bloating, visibility of the abdominal loops, collateral circulation, abdominal staining

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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