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临床试验/NCT06065215
NCT06065215招募中不适用

Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)

Children's Hospital of Eastern Ontario4 个研究点 分布在 1 个国家目标入组 319 人开始时间: 2024年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
319
试验地点
4
主要终点
Severe Post-prematurity Respiratory Disease (PRD)

研究概览

简要总结

Bronchopulmonary dysplasia (BPD) is a common, major complication of premature birth, associated with developmental and health consequences that continue into adulthood. Prediction of who will have these problems is challenging using traditional definitions of disease. It is believed that underdevelopment and injury occur in both lung tissue and the blood vessels in the lungs, with a sophisticated interplay between them that contributes to lung disease seen in prematurity. New magnetic resonance imaging (MRI) techniques can delineate tissue structure with unprecedented granularity, assessing lung tissue, blood vessels, and their interplay. The ability to identify, at an early stage, those infants destined for chronic lung disease with greater certainty will be useful in counseling families and critical for the effective introduction of promising new BPD therapies. 319 infants born less than 29 weeks gestation will be recruited from 4 centres, including 5 babies who received stem cell therapy in a clinical trial. Babies will be evaluated at 36 weeks post-conception with lung MRI, oscillometry (lung function), echocardiogram (heart ultrasound), and oscillometry. Lung health will be assessed every 3 months by phone questionnaire and chart review. At 18-21 months post-conception, babies will undergo neurodevelopmental assessment and lung function testing. The investigators will look at how well baseline MRI markers predict subsequent lung health and development, independently and combined with echocardiogram, lung ultrasound, and traditional markers of BPD. The investigators anticipate that these new MRI markers will measure lung health safely and longitudinally in babies born extremely preterm. By identifying predictors of longer-term lung disease, clinicians will be able to allocate resources to babies at the highest risk of severe disease. Further, The investigators envision that MRI will help identify babies who would benefit most from interventions like stem cell therapy and be useful for evaluation of future treatments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
35 Weeks 至 21 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born at <29 weeks gestation;
  • currently <36 weeks PMA.

排除标准

  • Known interstitial lung disease, congenital lung anomaly, ciliary dysfunction, immunodeficiency, cystic fibrosis, neuromuscular disease, or structural heart disease (other than atrial septal defect/hemodynamically insignificant ventricular septal defect/patent ductus arteriosus);
  • genetic syndrome or congenital anomaly;
  • contraindications for MRI or transport;
  • invasive or non-invasive ventilation that cannot be safely removed for MRI;
  • current respiratory infection;
  • family cannot speak English/French;
  • transferred to another hospital prior to baseline study visit
  • not receiving follow-up at one of the study centres.

结局指标

主要结局

Severe Post-prematurity Respiratory Disease (PRD)

时间窗: The evaluation will be conducted at regular intervals of every 3 months, commencing at 36 weeks PMA and continuing until the child reaches 18 months corrected age

PRD will be defined based on the consensus definition of the Prematurity and Respiratory Outcomes Program. This composite outcome characterizes clinically relevant persistent respiratory morbidity in early life. It will be evaluated every 3 months from 36 weeks PMA to 18 months corrected age through parent questionnaire and chart review. Severe PRD is defined as a positive response to any of the following: ≥2 respiratory-related hospitalizations, home oxygen at 3 months corrected age or any home respiratory support, systemic corticosteroid or pulmonary vasodilators after discharge home, chronic respiratory symptoms (cough without cold or wheeze at least once per week) despite concurrent inhaled corticosteroids in ≥ 2 questionnaires, or death secondary to a cardiopulmonary cause. PRD has been used as a clinical outcome in cohort studies and an American Thoracic Society guideline on optimal neonatal care pathways and predictive perinatal characteristics.

次要结局

  • Neurodevelopmental Impairment (NDI)(Neurodevelopmental impairment will be determined at the 18-21 months corrected age visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherri Katz

Division Head, Senior Scientist, Pediatric Respirologist

Children's Hospital of Eastern Ontario

研究点 (4)

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