Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05793723 |
Other study ID # |
4949 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 7, 2022 |
Est. completion date |
September 30, 2024 |
Study information
Verified date |
February 2024 |
Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact |
Stefano Nobile, MD, PhD, MSc |
Phone |
+390630151 |
Email |
stefano.nobile[@]policlinocogemelli.it |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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).
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).