Long-term Respiratory Complications in Infants With Perinatal COVID-19 (COLF)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: COVID-19; Respiratory Function Tests; Infant, Newborn, Diseases

Treatments: Diagnostic Test: Pulmonary function testing device

Study type: Observational

Funder types: Other

Identifiers

NCT05793723

4949

Details and patient eligibility

About

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).

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 3 months to 2 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• term infants;
• informed consent;
• history of perinatal COVID-19 (confirmed by nasopharyngeal swab tests, study group)

Exclusion criteria

• congenital malformations (particularly airway malformations);
• lack of informed consent

Trial design

40 participants in 2 patient groups

Cases

Description:

Infants with confirmed neonatal COVID-19 infection

Treatment:

Diagnostic Test: Pulmonary function testing device

Controls

Description:

Infants born to mothers with no history of COVID-19 infection during pregnancy and no neonatal COVID-19 infection

Treatment:

Diagnostic Test: Pulmonary function testing device