Evaluation of Long-term Respiratory Complications in Infants With Perinatal COVID-19: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical respiratory consequences of neonatal COVID-19 infection
研究概览
简要总结
Study outcomes and endpoints:
- Primary outcome: to assess clinical characteristics of infants with confirmed COVID-19 infection at birth and to evaluate long-term respiratory consequences of neonatal COVID-19 infection.
- Secondary outcome: to evaluate the prevalence and natural history of lung function impairment among infants with confirmed COVID-19 compared to infants with no history of COVID-19. To this end, infants will undergo pulmonary function testing (PFT) with the Exhalyzer D device (Eco Medics, Switzerland).
详细描述
In this prospective, observational longitudinal study, infants will undergo clinical and growth assessment at 6 and 12 months' follow-up. Respiratory complications, such as wheezing, infections, chronic cough will be recorded along with hospital admissions and drug prescription or use.
Infants will undergo PFT with the infants in the supine position, during quiet, natural sleep, according to American Thoracic Society/European Respiratory Society recommendations with measurement of lung volumes, flow, functional residual capacity, time to peak tidal expiratory flow/expiratory time ratio (tPTEF/tE)10. Lung ultrasound will be performed to rule out lung abnormalities. After allowing adaptation to the mask, the investigators will record tidal breathing, flow volume loops for >2 minutes or >20 artifact-free breaths. Using commercially available software (Spiroware, Ecomedics), the investigators will extract tidal breathing parameters: ratio of time to reach peak tidal expiratory flow to expiratory time (tPTEF/tE), tidal volume (VT), and respiratory rate (RR). tPTEF/tE is a reproducible and reliable marker of airway obstruction, can detect severe expiratory airway obstruction in infants with respiratory complaints and is associated with subsequent wheezing in infancy.
Appropriate statistical methods will be used to describe clinical characteristics of patients and compare groups (T-test, Mann-Whitney test, chi-squared test, multivariate analysis, mixed models depending on data distribution - evaluated with Shapiro-Wilk test - and data characteristics).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 2 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •term infants;
- •informed consent;
- •history of perinatal COVID-19 (confirmed by nasopharyngeal swab tests, study group)
排除标准
- •congenital malformations (particularly airway malformations);
- •lack of informed consent
结局指标
主要结局
Clinical respiratory consequences of neonatal COVID-19 infection
时间窗: 6 months of life
Number or patients with wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes
Clinical respiratory consequences of neonatal COVID-19 infection (i.e. wheezing)
时间窗: 12 months of life
Number or patients with wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes
次要结局
- Lung function parameters(6 months of life)
- Lung function parameters 5(12 months of life)
- Lung function parameters 4(12 months of life)
- Lung function parameters 2(6 months of life)
- Lung function parameters 3(6 months of life)
