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临床试验/NCT04135430
NCT04135430已完成不适用

Parental Assessment of the Quality of Life of Infants Under 12 Months of Age With Moderate Bronchiolitis Referred for Ambulatory Respiratory Physiotherapy

Association des Réseaux Bronchiolite11 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2019年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
192
试验地点
11
主要终点
QUALIN score

研究概览

简要总结

Infant bronchiolitis is a frequent pathology that is the cause of a very large number of medical outpatient and physiotherapy treatments in France. Many international studies and recommendations have invalidated any drug treatment during its management during the first episode. In France, the consensus conference promoted by the National Agency for Accreditation and Health Evaluation (ANAES) in September 2000 was in the same vein.

Regarding the respiratory physiotherapy component, posture drainage, vibration and percussion are not considered effective. ANAES recommended the use of respiratory physiotherapy with passive exhalation techniques. This is a method of care that has developed mainly in French-speaking countries, making it difficult to compare with the habits of Anglo-Saxon countries, which, more generally, do not prescribe it. In France, the level of evidence of its effectiveness is considered low (grade C). To date, the vast majority of studies have focused exclusively on a population of infants hospitalized for severe bronchiolitis. For this type of population, the value of such treatment to shorten the healing time has not been demonstrated. So much so that the ANAES, in its time, recommended that studies be carried out "on an outpatient basis" to assess their degree. In this respect, several recent studies have provided new data. Despite the reservations inherent in their methodologies and/or staff, they raise the question of the interest of the respiratory physiotherapy on an outpatient basis. In terms of professional practice, the American recommendations state that clinicians should educate family members about evidence-based diagnosis, treatment and prevention in bronchiolitis. Finally, an opinion survey concludes that holders of parental authority are seeking information on bronchiolitis and that approximately 90% have read the brochure given out of the maternity ward explaining the modes of transmission, manifestations, care and hygiene measures in the event of bronchiolitis. Pending new French recommendations, it seems legitimate to evaluate the level of perception of the effect of pediatric respiratory physiotherapy with increase in expiratory flow (IEF) in urban practice on the respiratory comfort of infants directly with families confronted with this pathology.

详细描述

Infant bronchiolitis is a frequent pathology that is the cause of a very large number of medical outpatient and physiotherapy treatments in France. Many international studies and recommendations have invalidated any drug treatment during its management during the first episode. In France, the consensus conference promoted by the National Agency for Accreditation and Health Evaluation (ANAES) in September 2000 was in the same vein.

Regarding the respiratory physiotherapy component, posture drainage, vibration and percussion are not considered effective. ANAES recommended the use of respiratory physiotherapy with passive exhalation techniques. This is a method of care that has developed mainly in French-speaking countries, making it difficult to compare with the habits of Anglo-Saxon countries, which, more generally, do not prescribe it. In France, the level of evidence of its effectiveness is considered low (grade C). To date, the vast majority of studies have focused exclusively on a population of infants hospitalized for severe bronchiolitis. For this type of population, the value of such treatment to shorten the healing time has not been demonstrated. So much so that the ANAES, in its time, recommended that studies be carried out "on an outpatient basis" to assess their degree. In this respect, several recent studies have provided new data. Despite the reservations inherent in their methodologies and/or staff, they raise the question of the interest of respiratory physiotherapy in ambulatory care. In terms of professional practice, the American recommendations state that clinicians should educate family members about evidence-based diagnosis, treatment and prevention in bronchiolitis. Finally, an opinion survey concludes that holders of parental authority are seeking information on bronchiolitis and that approximately 90% have read the brochure given out of the maternity ward explaining the modes of transmission, manifestations, care and hygiene measures in the event of bronchiolitis. Pending new French recommendations, it seems legitimate to evaluate the level of perception of the effect of pediatric respiratory physiotherapy with increase in expiratory flow (IEF) in urban practice on the respiratory comfort of infants directly with families confronted with this pathology.

研究设计

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

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infant up to 12 months of age
  • •Wang's score ≥ at 4 and < 9
  • •With first or second episode of bronchiolitis with a medical prescription for respiratory physiotherapy in the city.
  • •Consultation for a first session, or second session of respiratory physiotherapy

排除标准

  • •History or atopic predisposition
  • •History(s) of prematurity (34 weeks of amenorrhea or less)
  • •History of bronchopulmonary dysplasia
  • •Underlying heart disease, severe chronic lung disease
  • •Contraindication to the use of Kinesitherapy: prolonged corticosteroid therapy (more than one month), rickets, osteogenesis imperfecta, thrombocytopenia, rib fracture
  • •Opposition of holders of parental authority

结局指标

主要结局

QUALIN score

时间窗: 24 hours

Evolution of the Quality of life of infants and young children (QUALIN) score between before the session and 12 to 24 hours after the session.

次要结局

  • Questionnaire about child's respiratory comfort(8 days)
  • Questionnaire about understanding of the information(8 days)
  • Questionnaire about perceived professional competence.(8 days)
  • Questionnaire about security of care(8 days)
  • Questionnaire about accessibility of the care chain(8 days)

研究者

发起方
Association des Réseaux Bronchiolite
申办方类型
Unknown
责任方
Sponsor

研究点 (11)

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