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Prevention of Chronic Lung Disease (CLD - Prevention Study)

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 19, 2024 (before its estimated January 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Aug 2024); last known: Not Yet Recruiting
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06559670
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators: Azienda Ospedaliera Universitaria Policlinico "G. Martino", Azienda Ospedaliero-Universitaria di Parma, Ospedali Riuniti di Foggia
Conditions
(from sponsor)
Chronic Lung Disease
Related terms Bronchopulmonary Dysplasia, Pulmonary Disease, Chronic Obstructive
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov