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临床试验/NCT02588963
NCT02588963Unknown不适用

Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending

Polytechnic Institute of Porto2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Health Indicators

研究概览

简要总结

The aim of this study is to evaluate the influence of Primary and Secondary Prevention of Respiratory Infections in children up to 3 years-old attending daycare.

详细描述

Randomized controlled clinical trial including children up-to 3 years-old who attend daycare centres in O Porto.

To evaluate the Primary Prevention of Respiratory infections it was created and ministered to children's caregivers an education health session, regarding the prevention of respiratory infections of children, according to caregivers needs.

It is known that parental perceptions influence their behaviour in respect to the care of their unwell child. Sometimes misunderstandings occurred because parents' expressions of concern or requests for additional information were sometimes perceived as a challenge to the clinicians' diagnosis or treatment decision, which leads to unnecessary and unwanted prescribing of antibiotics. Health professionals should provide consistent information that promotes parental self-efficacy in the care of their unwell child.

To evaluate the Secondary Prevention of Respiratory Infections it was applied to children with signs of upper respiratory infections (rhinorrhea, cough and nasal obstruction) a nasal clearance protocol, developed by Guy Postiaux. This protocol consists on the application of physiological serum in the nostrils of the child, followed by forced nasal inspiration. The protocol is applied for 3 consecutive days, according to established criteria suggested by Postiaux. This intervention is indicated on Upper Respiratory Infections, such as rhinitis or rhinopharyngitis, with large amount of secretions in the upper airway and it is an effective adjuvant for medication. Forced nasal inspiration is able to create sufficient gas velocity to act on the pressure of the middle ear, through the eustachian tube, and may have an important role in the prevention of otitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children of both genders up to 3 years, born at term, pregnancy without complications, attending day care, residents in OPorto, with medical approval for intervention

排除标准

  • Children born prematurely, with lower respiratory infections, with chronic neurological, musculoskeletal, cardiac or respiratory disorders

结局指标

主要结局

Health Indicators

时间窗: 1 month after intervention

health status of the child was reported by caregivers concerning the number of episodes of respiratory infections and/or otitis.

次要结局

  • Middle Ear Condition(1 month)
  • Nasal Auscultation(1 month)
  • Severity of respiratory infection(1 month)

研究者

发起方
Polytechnic Institute of Porto
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Silva Alexandrino

MSc

Polytechnic Institute of Porto

研究点 (2)

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