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

NCT05793723 | Completed

• 1 other identifier: 4949
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Lung function parameters

  6 months of life

• Lung function parameters 2

  6 months of life

• Lung function parameters 3

  6 months of life

• Lung function parameters 4

  12 months of life

• Lung function parameters 5

  12 months of life

Study Arms (2)

Cases

Infants with confirmed neonatal COVID-19 infection

Diagnostic Test: Pulmonary function testing device

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

Interventions

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.

Cases; Controls

Eligibility Criteria

• Age: 3 Months - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

COVID-19; Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Stefano Nobile, MD, PhD, MSc

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 31, 2023
• Study Start: June 7, 2022
• Primary Completion: May 7, 2025
• Study Completion: May 30, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-03

Locations

IT (1)