Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793723
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-02-08
Brief Title:
Long-term Respiratory Complications in Infants With Perinatal COVID-19
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Evaluation of Long-term Respiratory Complications in Infants With Perinatal COVID-19 a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLF
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
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 SocietyEuropean Respiratory Society recommendations with measurement of lung volumes flow functional residual capacity time to peak tidal expiratory flowexpiratory time ratio tPTEFtE10 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 tPTEFtE tidal volume VT and respiratory rate RR tPTEFtE 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
Infants will undergo PFT with the infants in the supine position during quiet natural sleep according to American Thoracic SocietyEuropean Respiratory Society recommendations with measurement of lung volumes flow functional residual capacity time to peak tidal expiratory flowexpiratory time ratio tPTEFtE10 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 tPTEFtE tidal volume VT and respiratory rate RR tPTEFtE 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None