Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in Multiple Breath Washout
研究概览
简要总结
This study collects data on microbiological, genetic and environmental factors, as well as lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess the complex interaction of predisposing risk factors for impaired lung development and respiratory diseases.
详细描述
Background:
Lung development and growth is a complexly orchestrated process starting prenatally in the first embryonic weeks, and ending, with the last important stages of alveolarization from the 24th week onwards. By the time of birth, around one third of the total amount of alveoli has developed, while the rest develops during infancy and childhood. After birth, lung volume, airways and the gas-exchanging surface increase by a multiple, reaching the maximum lung size at around 25 years of age. A comprehensive understanding of lung growth and development is crucial in order to understand the pathophysiology of lung diseases. During childhood and ongoing lung growth, an important amount of respiratory diseases might develop.
Objectives:
Longitudinal assessment of lung growth and development, to examine respiratory morbidity such as Asthma and allergy, and the complex relationship between associated Risk factors mainly genetic predisposition and environmental factors on both lung development and subsequent respiratory morbidity, Therefore, longitudinal data on lung function and structure, on respiratory morbidity and on genetic, immunological, microbiological and environmental risk factors will be collected.
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term Born group (H): Healthy, white and term Born infants and Children. Born 38-42 weeks postconceptional.
- •Preterm group (P): Healthy, white preterm Born infants and Children. Born <37 weeks postconceptional. Which comply with the international criteria (Jobe and Bancalari) of a diagnosis of bronchopulmonary dysplasia (BPD), or of chronic lung disease of the new-born (CLD).
- •Risk pregnancy group (RP): White preterm Born infants and Children, including Twins. Born <37 weeks postconceptional. With fetal growth restriction (FGR), intrauterine growth restriction (IUGR) or preeclampsia (PE). With gestational Diabetes (GMD). With IVF or Amnion dysfunction.
- •Parents: language skills in German or French (by at least one parent).
- •Both of the parents can be Smokers and may be atopics (allergy of the mother and/or the Father).
- •Signed, written informed consent of the parents.
排除标准
- •Term Born group (H): Need of respiratory support > three days postnatal. Severe malformations or known diseases. Maternal drug abuse except smoking. Known sever maternal disease postpartum. Insufficient Knowledge of Project language (no German or French speaker). Pacemaker, continuous glucose monitor.
- •Preterm group (P): Severe malformations or known diseases. Maternal drug abuse except smoking. Known severe maternal disease postpartum. Insufficient Knowledge of Project language (no German or French speaker). Pacemaker, continuous glucose monitor.
- •Risk pregnancy group (RP): Insufficient Knowledge of Project language (no German or French speaker). Concurrent participation in another study. Participants, which lead to heterogeneity in genetic analysis and thus preclude any findings.
结局指标
主要结局
Change in Multiple Breath Washout
时间窗: Every third year from the age of 4-6 weeks/1 year till >16 years.
Longitudinal assessment of lung volume and ventilation inhomogeneity
Change in Spirometry
时间窗: Every third year from the age of 4-6 weeks/1 year till >16 years
Longitudinal assessment of long volumes
Change in Body plethysmography
时间窗: Every third year from the age of 4-6 weeks/1 year till >16 years.
Longitudinal assessment of ventilation inhomogeneity.
Change in Magnetic Resonance Imaging (MRI)
时间窗: At the age of 4-6 weeks, 1, 3, 6, 9, 12, 15 and >16 years.
Longitudinal assessment of regional lung perfusion and ventilation
Change in Nasal swabs
时间窗: At the age of 4-6 weeks, 1, 3, 6, 9, 12, 15 and >16 years.
Longitudinal assessment of viral and bacterial colonization of the nasal swab
Change in Weekly swabs
时间窗: Weekly from the visit at the age of 8-12 weeks till the age of 1 year.
Respiratory virus and bacterial diagnostic
Swabs during respiratory infection
时间窗: Any timepoint between the visit at the age of 4-6 weeks till the age of 1 year.
Respiratory viruses and Bacteria, changes of the microbial flora
次要结局
- Environmental pollution markers(At the age of 4-6 weeks, 1, 3, 6, 9, 12, 15 and >16 years.)
- Respiratory Rate (RR)(From the visit at the age of 4-6 weeks till the age of 1 year.)
- Urine(At the age of 4-6 weeks.)
- Cord blood(At birth.)
- Capillary blood markers(At the age of 1, 3, 6, 9, 12, 15 and >16 years.)
- Skin Prick Test(At the age of 3, 6, 9, 12, 15 and >16 years.)
- Volatile organic compound markers(At the age of 4-6 weeks, 1, 3, 6, 9, 12, 15 and >16 years.)
- Sputum(At the age of (3), 6, 9, 12, 15 and >16 years.)
- Nasal brushes(At the age of 1, 3, 6, 9, 12, 15 and >16 years.)
- Oropharyngeal swabs(At the age of 1, 3, 6, 9, 12, 15 and >16 years.)