Clinical Research Directory

Prevention of Chronic Lung Disease (CLD - Prevention Study)

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Official title: Prevention of Chronic Lung Disease: New High Risk Profile for Early Detection and Management Starting From Perinatal Life (CLD - Prevention Study)

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Locations (1)