About this trial
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
Eligibility criteria
Qualifiers
need for mechanical ventilation;
need for noninvasive respiratory support;
need for oxygen administration;
need for surfactant administration
Disqualifiers
Congenital malformations
Neuromuscular diseases.
Trial design
Treatments tested in this trial
- Blood sampling
Treatment groups
Sponsors and collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Collaborator
Azienda Ospedaliero-Universitaria di Parma
Collaborator
Ospedali Riuniti di Foggia
Collaborator