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Long-term Respiratory Complications in Infants With Perinatal COVID-19

NCT05793723 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-08-26

No results posted yet for this study

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).

Conditions

  • COVID-19
  • Infant, Newborn, Diseases
  • Respiratory Function Tests

Interventions

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Stefano Nobile, MD, PhD, MSc · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
3 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2025-05-07
Completion
2025-05-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05793723 on ClinicalTrials.gov