Slow Expiratory Technique Efficacy on 24 Hours Food Ingestion in Children Under Than 12 Months, Hospitalized for Bronchiolitis : a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Food ingestion
研究概览
简要总结
The purpose of this study is to determine wether a single chest physiotherapy session with slow expiratory technique (SET) improves infants with viral bronchiolitis quality of life (food intake and sleep) on the next 24 hours.
详细描述
Bronchiolitis is the most common lower respiratory viral infection in infants. Nowadays bronchiolitis is the first reason of children hospitalisation worldwide. Symptoms are based on airway inflammation associated to an increased mucus production and cell necrosis leading to a multifactorial airway obstruction. Recommended treatments are supportive care based on oxygenation and rehydration. Airway clearance techniques represented by chest physiotherapy remain controversial.
Considering that bronchiolitis impacts respiratory condition in young infants feeding and sleep may be reduced. Evaluating quality of life represented by feeding and sleep in hospitalized infants may be an important outcome in this population.
The investigators hypothesized that chest physiotherapy with SET will improve children's quality of life, especially 24 hours food intake and sleep.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children under 12 months
- •hospitalized for bronchiolitis
- •chest physiotherapy prescription
- •bronchial obstruction confirmed by physician and respiratory physiotherapist
- •Non-inclusion Criteria :
- •children more than 1 year
- •exclusive breastfeeding or enteral feeding
- •prematurity (gestational age < 35 weeks)
- •cardiac, neurological and pulmonary comorbidity
- •continuous oxygen supplementation or ventilatory support
- •chest physiotherapy contraindications
排除标准
- •side effects during chest physiotherapy : bradycardia <100 bpm, oxygen saturation<90%, general state alteration
- •outing, oxygen supplementation or parenteral nutrition less than 24 hours after randomization
- •chest physiotherapy cessation according to family request
研究组 & 干预措施
Chest physiotherapy with SET
Chest physiotherapy will be provided by a single physiotherapist not involved in outcomes assessment. Airway clearance technique will be Slow Expiratory Technique (SET). SET is a slow modulation of airflow in order to remove bronchial secretions within infants lungs. Experimental group will also benefit for standard medical and non-pharmacological care (e.g Standard Treatment)
干预措施: Chest physiotherapy with SET (Other)
Chest physiotherapy with SET
Chest physiotherapy will be provided by a single physiotherapist not involved in outcomes assessment. Airway clearance technique will be Slow Expiratory Technique (SET). SET is a slow modulation of airflow in order to remove bronchial secretions within infants lungs. Experimental group will also benefit for standard medical and non-pharmacological care (e.g Standard Treatment)
干预措施: Standard Treatment (Other)
Standard treatment
Medical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices.
干预措施: Standard Treatment (Other)
结局指标
主要结局
Food ingestion
时间窗: 24 hours following intervention
Total Food ingestion within 24 hours after intervention measured by nurses or parents
次要结局
- Sleep quality(24 hours following intervention)
- Oxygen saturation(Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention)
- Respiratory Distress(Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention)
- Respiratory rate(Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention)
- Heart Rate(Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention)
研究者
Yann Combret
Physiotherapist, MSc, PhD Candidate
Groupe Hospitalier du Havre