Actively Recruiting

Age: 0Days - 3Months
All Genders
ID07273643

Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm Newborns and Their Correlation With Severe Morbidity and Mortality

Led by University Hospital, Montpellier · Updated on 2026-02-23

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Montpellier

Lead Sponsor

I

INSERM U1046 Physiologie et médecine expérimentale du coeur et des muscles

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring the role of extracellular vesicles (EVs) in extremely premature infants born before 28 weeks of gestation. These tiny particles released by cells carry important information about the body's condition. In such premature infants, blood vessel problems can lead to severe complications like brain bleeding, lung injury, or serious infections. This study aims to identify early markers in EVs from umbilical cord blood that may predict these risks and improve care. The study collects venous cord blood samples from 30 eligible extremely premature newborns at Montpellier University Hospital. The blood plasma is processed shortly after birth to isolate EVs, which are then analyzed for size, number, and cellular origin using specialized laboratory techniques. A biobank is created to store plasma samples for future research. Some arterial cord blood samples are also collected for comparison in the first few participants. Participants' involvement includes blood collection at birth, rapid plasma processing within three hours, and laboratory analysis of EVs up to three months after collection. Clinical information on severe complications and mortality is tracked for up to one year. The study measures correlations between EV characteristics and early severe health issues, with the goal of better understanding and predicting risks for these vulnerable infants.

CONDITIONS

Brief Title

Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality

Who Can Participate

Age: 0Days - 3Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mother over 18 years old, able to speak and understand French
  • Newborn less than 28 weeks of gestation, born and hospitalized at Montpellier University Hospital
  • Umbilical cord venous blood collected immediately after birth (10 ml, minimum 3 ml if difficult) into an EDTA tube
  • Parental non-opposition to the study obtained before sample collection
Not Eligible

You will not qualify if you...

  • Stillborn infant
  • Failure to collect blood sample or start centrifugation more than 3 hours after birth
  • Lack of parental non-opposition
  • Lack of social security coverage
  • Individuals under legal guardianship
  • Participation in another ongoing research study with an active exclusion period

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - At birth

Participants have venous cord blood collected immediately after birth for analysis of extracellular vesicles. For the first five participants, an arterial cord blood sample is also collected.

1 visit at birth (in-person)

Long-term Monitoring

Duration - Up to 1 year

Participants are observed for the occurrence of severe morbidity or mortality and other clinical outcomes up to 1 year after birth.

Clinical information collected through study completion

Trial Site Locations

Total: 1 location

1

CHU de Montpellier

Montpellier, France

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Cord Blood Extracellular Vesicles Analyzed by Flow Cytometry with Thresholding Using 405 nm or 488 nm Laser Leads to Concurrent Results.

Kristýna Pekárková, Jakub Soukup, Marie Kostelanská...

https://pubmed.ncbi.nlm.nih.gov/34441255

Platelet Extracellular Vesicles in Cord Blood of Term and Preterm Newborns Assayed by Flow Cytometry: the Effect of Delay in Sample Preparation and of Sample Freezing.

A Hujacova, T Brozova, T Mosko...

https://pubmed.ncbi.nlm.nih.gov/34087976

Urine-derived extracellular vesicle miRNAs as possible biomarkers for and mediators of necrotizing enterocolitis: A proof of concept study.

Jeffrey D Galley, Pamela Mar, Yijie Wang...

https://pubmed.ncbi.nlm.nih.gov/33785202

Endostatin concentration in cord plasma predicts the development of bronchopulmonary dysplasia in very low birth weight infants.

Joakim Janér, Sture Andersson, Eero Kajantie...

https://pubmed.ncbi.nlm.nih.gov/19336373

Umbilical Cord Blood-Derived Exosomes From Very Preterm Infants With Bronchopulmonary Dysplasia Impaired Endothelial Angiogenesis: Roles of Exosomal MicroRNAs.

Xin-Qi Zhong, Qin Yan, Zhuang-Gui Chen...

https://pubmed.ncbi.nlm.nih.gov/33842462

Exosomal microRNA predicts and protects against severe bronchopulmonary dysplasia in extremely premature infants.

Charitharth Vivek Lal, Nelida Olave, Colm Travers...

https://pubmed.ncbi.nlm.nih.gov/29515035