Upper Airway Microbial Development During the First Year of Life
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in airway bacteria diversity during first 12 months of life.
研究概览
简要总结
This study tests the hypothesis that an increase in pathogenic bacteria within the infant airway leads to increased airway inflammation, decreased airway function and ultimately airway obstruction throughout the first one to two years of life.
详细描述
With the prevalence of asthma increasing each decade, our focus has shifted from treatment to understanding the pathogenesis of asthma so we may develop methods of prevention. With the advent of new bacterial detection techniques, we have the opportunity to examine the infant microbiome prior to the development of wheezing and subsequent asthma. Based on our knowledge that certain bacteria are associated with recurrent wheezing, we believe that an increase in pathogenic bacteria alters the airway epithelium resulting in airway inflammation. This chronic inflammation leads to airway obstruction, resulting in recurrent wheezing. By prospectively following children up to two years we have the opportunity to determine if changes seen in early infancy are established early and persist until 2 years of age. In addition, we propose to determine if the microbiome contributes to airway obstruction and episodes of wheezing with respiratory illness. This study tests the hypothesis that an increase in pathogenic bacteria within the infant airway leads to increased airway inflammation, decreased airway function and ultimately airway obstruction throughout the first one to two years of life.
The study has 3 Cohorts:
Cohort 1: Newborns with asthmatic mothers with enrollment from May 7, 2014 to June 1, 2016. Newborns from this cohort meet the below inclusion and exclusion criteria, however they follow a study visit schedule that follows them for 18 months (+/- 6 months).
Cohort 2: Newborns with asthmatic mothers with enrollment from June 2, 2016 going forward. Newborns from this cohort meet the below inclusion and exclusion criteria, however they follow a study visit schedule that follows them for 12 months (+/- 2 months).
Cohort 3: Newborns with healthy parents without atopy from June 2, 2016 going forward. Newborns from this cohort meet the below inclusion and exclusion criteria, however they follow a study visit schedule that follows them for 12 months (+/- 2 months).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moms age 14 and older (will sign Informed Consent Statement (ICS), not an assent)
- •Mother of child enrolled must have a physician diagnosis of asthma or being treated for asthma (for 140 subjects; 40 subjects will be recruited from mothers and fathers without atopy - asthma, eczema, seasonal allergies)
- •Child must be enrolled during first week of life
- •Signed informed consent from parent(s) or legal guardian(s)
排除标准
- •Child has a history of wheezing or underlying lung disease
- •Respiratory complications at birth (airway support higher then nasal cannula)
- •Born earlier then 37 weeks gestation
- •Congenital heart defects (not including Patent Ductus Arteriosus (PDA), hemodynamically insignificant Ventricular Septal Defect (VSD) or Atrial Septal Defect (ASD)
- •Underlying neuromuscular disease
- •Severe upper airway obstruction, sleep apnea, tracheomalacia, or laryngomalacia
- •Hydrocephalus
- •History of seizures
- •History of arrhythmia and baseline oxygenation level <90% on room air
- •Infant is non-viable
- •Severe gastroesophageal reflux
- •Prior chest surgery or structural abnormalities of the lungs or chest wall
- •Has a history of adverse reaction to chloral hydrate
- •Ward of the state
- •Any physical finding(s) that would compromise the safety of the subject or the quality of the study data as determined by the site investigator
结局指标
主要结局
Change in airway bacteria diversity during first 12 months of life.
时间窗: Birth and 12 months (+/- 2 months)
Will use microbiome diversity measurements to determine if changes in diversity occur over time.
次要结局
- Change in inflammatory markers (IL-4, IL-5 and IL-13) during first 12 months of life.(Birth and 12 months (+/- 2 months))
- Change in airway function measurements FEV0.5 during 12 months of life.(Birth and 12 months (+/- 2 months))
研究者
Kirsten Kloepfer
Assistant Professor of Pediatric Pulmonology, Allergy and Sleep Medicine
Indiana University