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Prevention of Chronic Lung Disease (CLD - Prevention Study)

NCT06559670 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-08-19

No results posted yet for this study

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

Conditions

Interventions

OTHER

Blood sampling

\- Collection and analysis of blood samples

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico "G. Martino"

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria di Parma

    collaborator OTHER

  • Ospedali Riuniti di Foggia

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Giovanni Vento · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Hour
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-01-31
Completion
2026-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06559670 on ClinicalTrials.gov