Edinburgh and Lothian Virus Intervention Study in Kids (ELVIS Kids): A Randomised Controlled Trial of Hypertonic Saline Nose Drops in Children With Upper Respiratory Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Time to the first report that the child is "not unwell".
研究概览
简要总结
ELVIS Kids is a parallel, open label, randomised controlled trial (RCT) of Hypertonic Saline (HS) nose drops (~2.6% NaCl) vs. standard care in children <7 years of age with symptoms of an Upper Respiratory Tract Infection (URTI).
详细描述
The study will run over ~30 months. Children are recruited prior to, or within 48 hours of developing URTI symptoms by advertising in areas such as local schools, nurseries, health centres and workplaces as well as social media. For the purposes of this study an URTI is defined as: at least two respiratory symptoms (nasal stuffiness, runny nose, cough, sore throat, or sneezing) OR one respiratory symptoms and at least one systemic symptom (lethargy, muscle pain, headache, pyrexia ≥38°C).
Willing parents/guardians, of children <7 years of age, will be directed by the study advertising to contact the research team at their local research site if they are interested in participating. Children will be randomised to either a Control arm of standard symptomatic care, or an Intervention arm of 3 drops each nostril of HS at least 4 times a day until 24 hours after asymptomatic or maximum of 28 days. All participants will be requested to obtain a mid-turbinate nasal swab prior to first nasal HS drops (repeated daily for 5 days), a daily symptom diary (CARIFS, a valid illness measure in the UK), and an end of illness questionnaire (healthcare use, adverse events, acceptability, infection in household contacts, parental time taken off usual activities). Parent/guardian of the children allocated to the intervention arm will be taught how to prepare the HS. Parent/guardian of children who are asymptomatic at recruitment are requested to inform CCRF when the child develops an URTI (within 48 hours) and follow the instructions already provided to them when given the go-ahead to start the trial. On day 28, parents/guardians will be contacted to determine if their child suffered from wheeze either during the illness or at any point until day 28. Participation in the study will end on day 28.
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
- Single (Outcomes Assessor)
盲法说明
The team in the virology lab carrying out the analysis of the nasal swabs will be blinded to the allocation of the participant.
入排标准
- 年龄范围
- 40 Weeks 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between corrected gestational age of ≥40 weeks and <7 years of age
- •Children without URTI OR ≤48 hours of URTI* starting.
- •A URTI being defined as at least two respiratory symptoms (nasal congestion (i.e. stuffy nose), runny nose, cough, sore throat) OR one respiratory symptom + at least one systemic symptom (Low energy/tired, muscle aches/pains, headache, fever ≥38°C).
排除标准
- •Children needing immediate medical attention
- •Children using saline drops/sprays at the time of randomisation
- •Children on immunosuppressive medication, regular oral/inhaled steroids, regular antibiotics (use of antibiotics is allowed as long as the child does not need regular antibiotics)
- •Children with a known chronic illness (e.g. cystic fibrosis, cardiac, renal, liver, lung, neurological conditions) apart from wheeze or asthma which are not exclusions if the child is otherwise well and not on regular steroids)
- •Children being followed up for developmental delay
- •Children receiving the nasal flu vaccine ≤14 days ago
- •Children taking part in another interventional trial
- •If parents/guardians indicating that they are unable to comply with the study protocol prior to randomisation
- •If parents/guardians are unable to understand written or spoken English
- •Children randomised to ELVIS KIDS on a previous episode of URTI
- •Children with a concurrently participating sibling
研究组 & 干预措施
Hypertonic Saline ~2.6% NaCl
3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days
干预措施: Na Cl solution (Other)
Standard Care
Control arm of standard symptomatic care only
结局指标
主要结局
Time to the first report that the child is "not unwell".
时间窗: Maximum of 28days
Time until child not unwell
次要结局
- Participants needing GP appointments- Frequency of contacts(1-28 days (or until child is well))
- Number of participants attending hospital and diagnosis - Frequency of contacts(1-28 days (or until child is well))
- Length of stay in hospital if admitted(1-28 days (or until child is well))
- The length of time for individual symptoms to resolve(1-28 days (or until child is well))
- Contacting healthcare (NHS 24, OOH, GP) -Number of participants(1-28 days (or until child is well))
- Severity of all symptoms(1-28 days (or until child is well))
- Severity of individual symptoms(1-28 days (or until child is well))
- Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts(1-28 days (or until child is well))
- Participants needing GP appointments- Number of participants(1-28 days (or until child is well))
- Number of participants attending hospital and diagnosis - Number of participants(1-28 days (or until child is well))
- Duration of viral shedding(Days 1-5)
- Reduction in viral shedding(Days 1-5)
- Number of participants reporting wheeze during illness and between end of illness to 28 days(Day 28)
- Number of participants reporting over the counter medication use(1-28 days (or until child is well))
- Rate of reduction in viral shedding(Days 1-5)
- Reduction in transmission to household contacts(1-28 days (or until child is well))
- Number of participants reporting side effects of nasal drops(1-28 days (or until child is well))
- Types and severity of side effects reported(1-28 days (or until child is well))
- Number of days lost from school/nursery for child(1-28 days (or until child is well))
- Number of days lost from work for parent/guardian(1-28 days (or until child is well))
- Cost of over the counter medication used(1-28 days (or until child is well))