Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Mild to Moderately Severe Bronchiolitis - A Double Blind Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean Change in Clinical Severity Score
研究概览
简要总结
To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity scores among children aged 6 weeks to 24 months with bronchiolitis.
详细描述
Introduction and Rationale:
Bronchiolitis is a common problem with significant morbidity, and occasional mortality among young infants. Diagnostic testing, indications for hospitalization, eligibility criteria for discharge and therefore, the length of hospital stay for bronchiolitis vary globally, suggesting a lack of consensus and an opportunity to improve care for this common disorder. Likewise, despite the frequency of this condition there is no single, widely practiced, evidence-driven and universally accepted therapeutic guidelines other than supportive care. Recent studies have shown promising results regarding the role of nebulised 3% hypertonic saline in the treatment of bronchiolitis.
This therapy might obviate the need for hospital admission and reduce the length of hospital stay, if found effective. The implications of this would be that children return home early and parents return to work earlier, resulting in reduction of the morbidity and cost associated with the disease.
Trial Design This study was a prospective, interventional, parallel-assigned, double-blind, (subject,caregiver, investigator, outcome assessor) randomized controlled trial.
Ethical Clearance The study was approved by Institutional Review Board and Ethics Committee, Tribhuvan University Teaching Hospital, Institute of Medicine as well as The Institutional Review Board of Kanti Children's Hospital.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 weeks to 24 Months.
- •First episode of wheezing
- •Fever, cough and watery nasal discharge
- •Exclusion Criteria :
- •Any underlying cardiovascular disease.
- •Prior wheezing.
- •Clinical Severity Score >
- •Atopic dermatitis, allergic rhinitis or asthma.
- •Oxygen saturation (SpO2) <85% on room air.
- •Obtunded consciousness.
- •Previous treatment with bronchodilators within 4 hours.
- •Any steroid therapy within 48 Hours.
排除标准
- 未提供
研究组 & 干预措施
Standard Treatment
L-Epinephrine and Normal Saline (0.9%)
干预措施: L-Epinephrine and Normal Saline (0.9%) (Drug)
Study Treatment
L-Epinephrine and Hypertonic Saline (3%)
干预措施: L-Epinephrine and Hypertonic Saline (3%) (Drug)
结局指标
主要结局
Mean Change in Clinical Severity Score
时间窗: 2 hours
Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline. Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children. The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa. The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992). This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale.
次要结局
- Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation(At the end of 2 hours)
- Relapse Rate(24 hours)
- Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week(7 days)
- Missed Days of Work of Caregivers(7 days)
- Persistence of Cough at the End of 1 Week(7 days)
研究者
Dr. Aayush Khanal, MD
MD
Tribhuvan University Teaching Hospital, Institute Of Medicine.