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OpenTrials
Completed

NCT Number: NCT05793723

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

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).

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Clinical respiratory consequences of neonatal COVID-19 infection

    Time frame: 6 months of life

    Number or patients with wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes

  2. Clinical respiratory consequences of neonatal COVID-19 infection (i.e. wheezing)

    Time frame: 12 months of life

    Number or patients with wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes

Secondary outcomes

  1. Lung function parameters

    Time frame: 6 months of life

    Tidal volume (ml)

  2. Lung function parameters 2

    Time frame: 6 months of life

    Respiratory rate (breaths per minute)

  3. Lung function parameters 3

    Time frame: 6 months of life

    Time to peak expiratory flow/expiratory time (ratio)

  4. Lung function parameters 4

    Time frame: 12 months of life

    Functional residual capacity (ml)

  5. Lung function parameters 5

    Time frame: 12 months of life

    Lung clearance index 2.5 and 5.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: COLF

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2023
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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