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

Recruiting

• Conditions: Infant, Newborn, Diseases; COVID-19; Respiratory Function Tests
• Interventions: Diagnostic Test: Pulmonary function testing device

• Registration Number: NCT05793723
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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).

Detailed 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-06-07
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-03-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-06-07
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Pulmonary function testing device	Infants with confirmed neonatal COVID-19 infection
Controls	Pulmonary function testing device	Infants born to mothers with no history of COVID-19 infection during pregnancy and no neonatal COVID-19 infection

Primary Outcome Measures

Name	Time	Method
Clinical respiratory consequences of neonatal COVID-19 infection	6 months of life	Number or patients with wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes
Clinical respiratory consequences of neonatal COVID-19 infection (i.e. wheezing)	12 months of life	Number or patients with wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes

Secondary Outcome Measures

Name	Time	Method
Lung function parameters 3	6 months of life	Time to peak expiratory flow/expiratory time (ratio)
Lung function parameters	6 months of life	Tidal volume (ml)
Lung function parameters 5	12 months of life	Lung clearance index 2.5 and 5.
Lung function parameters 4	12 months of life	Functional residual capacity (ml)
Lung function parameters 2	6 months of life	Respiratory rate (breaths per minute)

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Roma, Italy