Prevention of Chronic Lung Disease (CLD - Prevention Study)
NCT Number: NCT06559670
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Lung Disease
Interventions: OTHER: Blood sampling
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators: Azienda Ospedaliera Universitaria Policlinico "G. Martino"|Azienda Ospedaliero-Universitaria di Parma|Ospedali Riuniti di Foggia
Sex: ALL
Age: CHILD
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2026-09
Locations: Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Neonatologia, Rome, RM, 00168, Italy

Summary:
Primary endpoint:

- prospectively identify potential biomarkers able to predict the severe course of pulmonary funcion in the first 12 months of life and realize a new profile to early identify hugh risk newborns

Secondary endpoints:

* detect genetic variance causation model (by MiSeq Illumina platform) correlating with severe pulmonary dysfunction and asthma development;
* detect MIcroRNAs as well as anti- and pro-inflammatory cytokine variations (MIP-1α, MCP-1, IL-8, TNF-α, IFN-ɣ, IL-10) correlating with the severity of pulmonary dysfunction in the first 12 months of life and the risk of asthma development

Population: preterm infants with gestational age \< 32 weeks who have suffered from acute respiratory insufficiency at birth

Intervention:

* Assessment of prenatal risk factors.
* Collection of the following biological specimens: 1) a vaginal swab from the mothers of enrolled infants 2) a placenta sample 3) an arterial or venous cord blood sample at birth 4) peripheral blood samples from enrolled infants: the first within 48 hours of life, the subsequent ones at 7 and 28 days of life and at 6 and 12 months of age 5) bronchoalveolar lavage (BALF) samples exclusively in infants intubated for clinical reasons within the first 24 hours of life, at 7 and 28 days of life. 6) first meconium sample issued and subsequent stool samples at 7 and 28 days of life and at 6 and 12 months of age, of enrolled infants
* Respiratory Functionality Testing at 6 and 12 months of age

Primary Outcome Measures: Identification of biomarkers of a severe course of pulmonary function by the study of microbiome and of oxidative stress, 8-10 candidate MIcroRNAs (absolute levels), particularly miR-451, miR-29b and miR-16, will be studied on serum obtained from cord blood and blood sampling of the newborn at 48 hours of life.

To detect changes in anti- and pro-inflammatory cytokines (MIP-1α, MCP-1, IL-8, TNF-α, IFN-ɣ, IL-10; pg/ml) correlated with disease severity over time, cord blood will be used, and peripheral blood samples (2 ml in an EDTA tube) will be taken from enrolled infants by 48 hours of life, at 7 and 28 days of age, and at 6 and 12 months of age. Cytokines will be assayed by commercially available ELISA kit according to the manufacturer's instructions and will be expressed in pg/ml., 12 months
Secondary Outcome Measures: Analysis of genetic variance causation model in patients with and without severe pulmonary dysfunction and asthma development, Genetic variance causality modeling will be performed in all enrolled infants at 48 hours of age (500 μL whole blood), using a MiSeq Illumina platform that enables the application of next-generation sequencing technologies., 12 months
Other Outcome Measures: MIcroRNAs (miR) and anti- and pro-inflammatory cytokine levels in patients with and without respiratory symptoms in the first 12 months of life, 8-10 candidate MIcroRNAs (absolute levels), particularly miR-451, miR-29b and miR-16, will be studied on serum obtained from cord blood and blood sampling of the newborn at 48 hours of life.

To detect changes in anti- and pro-inflammatory cytokines (MIP-1α, MCP-1, IL-8, TNF-α, IFN-ɣ, IL-10; pg/ml) correlated with disease severity over time, cord blood will be used, and peripheral blood samples (2 ml in an EDTA tube) will be taken from enrolled infants by 48 hours of life, at 7 and 28 days of age, and at 6 and 12 months of age. Cytokines will be assayed by commercially available ELISA kit according to the manufacturer's instructions and will be expressed in pg/ml., 12 months