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Study outcomes and endpoints:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Infants with confirmed neonatal COVID-19 infection |
| |
| Controls | Infants born to mothers with no history of COVID-19 infection during pregnancy and no neonatal COVID-19 infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary function testing device | Diagnostic Test | Patients will undergo pulmonary function tests with the Exhalyzer D (Ecomedics, Switzerland) device. This device consists of 1) an ultrasonic flow measuring system for measuring flow, volume and molecular mass, 2) a nitrogen washout system to measure functional residual capacity (FRC) and other indices, 3) a carbon dioxide infrared measurement device for monitoring the level of carbon dioxide in exhaled breath. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical respiratory consequences of neonatal COVID-19 infection | Number or patients with wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes | 6 months of life |
| Clinical respiratory consequences of neonatal COVID-19 infection (i.e. wheezing) | Number or patients with wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes | 12 months of life |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function parameters | Tidal volume (ml) | 6 months of life |
| Lung function parameters 2 | Respiratory rate (breaths per minute) | 6 months of life |
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Inclusion Criteria:
Exclusion Criteria:
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In this prospective, observational longitudinal study, infants with and without history of COVID-19 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. Pulmonary function tests will be performed during spontaneous, quiet sleep.
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Nobile, MD, PhD, MSc | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Gemelli IRCCS | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| Lung function parameters 3 | Time to peak expiratory flow/expiratory time (ratio) | 6 months of life |
| Lung function parameters 4 | Functional residual capacity (ml) | 12 months of life |
| Lung function parameters 5 | Lung clearance index 2.5 and 5. | 12 months of life |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |