COLF: Long-term Respiratory Complications in Infants With Perinatal COVID-19
Study Details
Study Description
Brief Summary
Study outcomes and endpoints:
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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.
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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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cases Infants with confirmed neonatal COVID-19 infection |
Diagnostic Test: Pulmonary function testing device
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.
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| Controls Infants born to mothers with no history of COVID-19 infection during pregnancy and no neonatal COVID-19 infection |
Diagnostic Test: Pulmonary function testing device
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.
|
Outcome Measures
Primary Outcome Measures
- Clinical respiratory consequences of neonatal COVID-19 infection [6 months of life]
Wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes
- Clinical respiratory consequences of neonatal COVID-19 infection (i.e. wheezing) [12 months of life]
Wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes
Secondary Outcome Measures
- Lung function parameters [6 months of life]
Tidal volume (ml)
- Lung function parameters [6 months of life]
Respiratory rate (breaths per minute)
- Lung function parameters [6 months of life]
Time to peak expiratory flow/expiratory time (ratio)
- Lung function parameters [12 months of life]
Functional residual capacity (ml)
- Lung function parameters [12 months of life]
Lung clearance index 2.5 and 5.
Eligibility Criteria
Criteria
Inclusion Criteria:
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term infants;
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informed consent;
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history of perinatal COVID-19 (confirmed by nasopharyngeal swab tests, study group)
Exclusion Criteria:
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congenital malformations (particularly airway malformations);
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lack of informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Gemelli IRCCS | Roma | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4949