Prevention of Chronic Lung Disease (CLD - Prevention Study)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-24
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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

42 Participants
are divided into 1 treatment group

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