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

COVID-19 Clinical Trial

— COLF  

Official title:

Evaluation of Long-term Respiratory Complications in Infants With Perinatal COVID-19: a Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05793723
• Other study ID #: 4949
• Status: Recruiting
• 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
• 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 2 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Lung function parameters	Tidal volume (ml)	6 months of life
Secondary	Lung function parameters 2	Respiratory rate (breaths per minute)	6 months of life
Secondary	Lung function parameters 3	Time to peak expiratory flow/expiratory time (ratio)	6 months of life
Secondary	Lung function parameters 4	Functional residual capacity (ml)	12 months of life
Secondary	Lung function parameters 5	Lung clearance index 2.5 and 5.	12 months of life