COVID-19COLFNCT05793723
Long-term Respiratory Complications in Infants With Perinatal COVID-19
An observational study of COVID-19 and Infant, Newborn, Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 3 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Infant, Newborn, Diseases, Respiratory Function Tests
- What is being tested?
- Pulmonary function testing device
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jun 2022to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- term infants;
- informed consent;
- history of perinatal COVID-19 (confirmed by nasopharyngeal swab tests, study group)
Who cannot join
- congenital malformations (particularly airway malformations);
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Long-term Respiratory Complications in Infants With Perinatal COVID-19: a Pilot Study.
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).
Read the 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).
- Being tested
- Pulmonary function testing device
- Medical subject headings
- COVID-19, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function testing deviceDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Infants with confirmed neonatal COVID-19 infection Receives: 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 Receives: Diagnostic Test: Pulmonary function testing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical respiratory consequences of neonatal COVID-19 infection
Number or patients with wheezing, use of bronchodilators, steroids, hospitalizations for respiratory causes
Measured: 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
Measured: 12 months of life
Secondary outcomes (5)
Lung function parameters
Tidal volume (ml)
Measured: 6 months of life
Lung function parameters 2
Respiratory rate (breaths per minute)
Measured: 6 months of life
Lung function parameters 3
Time to peak expiratory flow/expiratory time (ratio)
Measured: 6 months of life
Lung function parameters 4
Functional residual capacity (ml)
Measured: 12 months of life
Lung function parameters 5
Lung clearance index 2.5 and 5.
Measured: 12 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start7 Jun 2022
- Primary completion7 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Nobile, MD, PhD, MSc, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793723
- Sponsor's protocol ID
- 4949
- Acronym
- COLF
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Respiratory Complications in Infants With Perinatal COVID-19: a Pilot Study.
- ClinicalTrials.gov ID
- NCT05793723
- Acronym / sponsor ID
- COLF / 4949
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Pulmonary function testing deviceInfants with confirmed neonatal COVID-19 infection |
| Controls | – | Diagnostic Test: Pulmonary function testing deviceInfants born to mothers with no history of COVID-19 infection during pregnancy and no neonatal COVID-19 infection |
Who may qualify
- Ages
- 3 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- term infants;
- informed consent;
- history of perinatal COVID-19 (confirmed by nasopharyngeal swab tests, study group)
Key exclusion criteria (2 listed)
- congenital malformations (particularly airway malformations);
- lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary function testing devicePatients 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. | Diagnostic test | Cases, Controls |
Primary outcome
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
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
5 secondary outcomes
Lung function parameters
Time frame: 6 months of life
Lung function parameters 2
Time frame: 6 months of life
Lung function parameters 3
Time frame: 6 months of life
Lung function parameters 4
Time frame: 12 months of life
Lung function parameters 5
Time frame: 12 months of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Nobile, MD, PhD, MSc principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Infant, Newborn, Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical respiratory consequences of neonatal COVID-19 infection (time frame: 6 months of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.