Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
研究概览
简要总结
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.
详细描述
This is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. Participants will receive bacterial lysate (OM-85/Broncho-Vaxom, 3,5mg) or placebo powder for ten days each month, from 6-10 weeks after birth until 12 months after birth. At 12 months, parents of participants are asked to join in Protea-2. If they do, participants in the treatment arm of year 1 are randomised again over placebo and OM-85 and treated until the age of 24 months. Clinical data will be continuously collected by e-Health and 3 (possibly digital) study visits; with optional biological sampling and lung function at baseline, 6 and 12 months.
Main study parameters are doctor diagnosed lower RTI and wheezing episodes in the first year of life. Biological sampling will allow investigation of immune maturation, as well as microbiome development in the respiratory tract and gut. Also, biomarkers for risk-group selection and/or treatment success will be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study subjects, all study investigators including the principal investigator and treating physicians will be blinded for the allocation during the complete study period. A sealed envelope with the treatment allocation per code is present at the pharmacy to be used only when 1) crucial for a medical emergency, 2) the participant will continue with Protea-2 and the database concerning year 1 is locked for this specific participant, and 3) at trial completion after the last patient last visit.
入排标准
- 年龄范围
- 6 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at delivery between 30+0 and 35+6 weeks
- •Postnatal age at least 6 weeks at randomization & postmenstrual age at least 37 weeks
- •Written informed consent by both parents or formal caregivers
排除标准
- •Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder.
- •Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding
- •Parents unable to speak and read Dutch/English language
- •Known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.
研究组 & 干预措施
Placebo
Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug.
干预措施: Placebo (Other)
Broncho-Vaxom treatment
Infants in this arm will be given 3,5mg bacterial lysate (OM-85) 10 days per month from 6 weeks after birth until 12 months of age.
At age 12 months they will be (if informed consent for Protea-2 is provided) randomised over Broncho-Vaxom treatment and placebo again.
干预措施: Broncho-Vaxom (Drug)
结局指标
主要结局
Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
时间窗: In the first year of life.
Recorded by frequent questionnaires
Protea-1: Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life.
Protea-1: Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life.
Protea-2: The time to the first lower respiratory episode after 12 months of age.
Protea-2: The time to the first lower respiratory episode after 12 months of age.
次要结局
- Time to first lower RTI or wheezing episode(In the first and second year of life.)
- Total number of RTI(In the first and second year of life.)
- Total number of wheezing episodes(In the first and second year of life.)
- Distribution of viruses(In the first year of life.)
- Medication use (bronchodilators, corticosteroids, antibiotics)(In the first and second year of life.)
- Lung function as measured by expiratory variability index (Ventica)(In the first year of life.)
- Quality of life questionnaires(In the first and second year of life.)
- (serious) adverse events(In the first year of life.)
- Serum specific IgE (allergen sensitization) at 12 months(At age 12 months)
- Infant vaccination titers at 12 months(At age 12 months)
- Costs- and cost-effectiveness(In the first and second year of life.)
- time to first lower RTI or wheezing episode in the first year of life
- total number of RTI in the first and second year of life
- total number of wheezing episodes in the first and second year of life
- distribution of viruses during lower RTI/wheezing
- medication use (bronchodilators, corticosteroids, antibiotics)
- lung function as measured by expiratory variability index
- quality of life
- (serious) adverse events (respiratory episodes are not regarded as an (S)AE since they comprise primary and secondary outcomes)
- serum specific IgE (allergen sensitization) at 12 months
- infant vaccination titers at 12 months
- costs- and cost-effectiveness
研究者
Gerdien Tramper
Pediatrician/clinical researcher, principal investigator
Franciscus Gasthuis