AzTrials
AzTrials

Intraventricular HemorrhageVEEPNCT07273643

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

An observational study of Intraventricular Hemorrhage and Pulmonary Hemorrhage, run by University Hospital, Montpellier at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation. EVs are tiny particles released by cells that carry important information about the body's condition. Read more about this study

Who is it for?
Ages 0 days to 3 months
What is being tested?
Venous Cord blood sample and Arterial cord blood sample
How many people
30 participants
Where
1 siteFrance
Study dates
13 Jan 2026to 13 Oct 2027
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 days to 3 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: All live-born infants born before 28 weeks of gestation (extremely preterm) who were hospitalized at Montpellier University Hospital during the inclusion period and had cord blood collected immediately after birth.

Who may be able to join

  • 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 (from the segment between the cord clamp and the placenta), with a volume of 10 ml (which can be reduced to 3 ml if collection is difficult) into an EDTA tube.
  • Parental non-opposition to the study obtained before sample collection

Who cannot join

  • Stillborn infant
  • Handling failure: failure to collect the sample or start the first centrifugation more than 3 hours after birth
  • General regulatory criteria: failure to obtain parental non-opposition, lack of social security coverage, individuals under legal guardianship, or participation in another ongoing research study with an active exclusion period

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting

  • CHU de Montpellier

    Montpellier

    arthur gavotto, PR, 04 67 33 66 09, a-gavotto@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation. EVs are tiny particles released by cells that carry important information about the body's condition. In extremely premature infants, blood vessels may not function properly, leading to serious health problems such as bleeding in the brain, lung injury, or severe infections.

Researchers believe that analyzing EVs in the umbilical cord blood of these infants may help predict which babies are at higher risk of developing these complications. By studying the size, number, and type of EVs, the team hopes to identify early markers that can guide doctors in providing better care.

Read more

The study will collect cord blood from 30 eligible infants born at the CHU of Montpellier. Blood samples will be processed to isolate platelet-poor plasma, which contains EVs. This plasma will be stored in a biobank, allowing future research on EVs and their role in extreme prematurity. EVs will then be analyzed in the laboratory to assess their characteristics and any links to severe health issues.

The findings from this study could improve understanding of circulatory problems in extremely premature infants, help identify early predictors of severe complications, and inform better monitoring and treatment strategies. The creation of a plasma biobank also provides a valuable resource for future research to enhance care and outcomes for this vulnerable population.

Being tested
Venous Cord blood sample, Arterial cord blood sample
Keywords
ELGAN, Extremely Low Gestational Age Newborn (ELGAN), Extracellular vesicles, EVs, Intraventricular hemorrage, Pulmonary hemorrhage, Bronchopulmonary Dysplasia
Medical subject headings
Death, Bronchopulmonary Dysplasia, Shock, Enterocolitis, Necrotizing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venous Cord blood sampleBiological

    Also called EVs extraction and characterization, Blood centrifugation

    Venous cord blood sample will be collected at birth (10 mL; if not possible, a minimum of 3 mL) from the umbilical vein into an EDTA tube. Plasma was isolated from blood cells by two centrifugation steps. Extracellular vesicles (EVs) were then isolated from plasma using additional centrifugation and ultracentrifugation steps. EVs were sized and counted using a Zetasizer, and their cellular origin was characterized by nanocytometry.

  • Arterial cord blood sampleBiological

    Also called EVs extraction and characterization, Blood centrifugation

    Arterial cord blood sample will be collected at birth (10 mL; if not possible, a minimum of 3 mL) from the umbilical vein into an EDTA tube for the five first inclusions (succeed). Plasma was isolated from blood cells by two centrifugation steps. Extracellular vesicles (EVs) were then isolated from plasma using additional centrifugation and ultracentrifugation steps. EVs were sized and counted using a Zetasizer, and their cellular origin was characterized by nanocytometry.

Study groups in NCT07273643
Study groupRoleWhat they receive
Extremely Low Gestational Age Newborns without severe morbidity or mortalityExtremely Low Gestational Age Newborns (ELGANs) born at Montpellier Hospital before 28 weeks of gestation, who were admitted to the neonatal unit, had cord blood collected at birth, and did not experience severe morbidity (early shock, intraventricular hemorrhage, or pulmonary hemorrhage) or death before discharge.
Receives: Biological: Venous Cord blood sample; Biological: Arterial cord blood sample
Extremely Low Gestational Age Newborns with severe morbidity or mortalityExtremely Low Gestational Age Newborns (ELGANs) born at Montpellier Hospital before 28 weeks of gestation, who were admitted to the neonatal unit, had cord blood collected at birth, and experienced severe morbidity (early shock, intraventricular hemorrhage, or pulmonary hemorrhage) or death before discharge.
Receives: Biological: Venous Cord blood sample; Biological: Arterial cord blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between occurence of early severe morbidity mortality and characterization of Extracellular vesicles (EVs)

    The primary outcome is the correlation between occurence of early severe morbidity mortality and the characterization of Extracellular vesicles (EVs) for venous cord blood plasma :

    1. EV were isolated from venous cord blood plasma using sequential centrifugation and ultracentrifugation steps. EVs were then characterized for size (nm) and concentration (EVs/µL) using a Zetasizer, and their cellular origin was determined by nanocytometry.
    2. Early severe morbidity or mortality during the hospital stay is defined as the occurrence of at least one of the following events:
    • Refractory shock (requiring fluid resuscitation or vasopressor support)
    • Pulmonary Hemorrhage
    • Severe Intraventricular Hemorrhage (grade 3 or 4, Papille classification)
    • Death before discharge

    Measured: Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection. Clinical informations(occurence of early severe morbidity and mortality): through study completion, up to 1year

Secondary outcomes (3)

  1. Correlation between occurrence of other morbidity before discharge and the EVs characterization

    This secondary outcome will explore the correlation between the characterization of venous cord blood extracellular vesicles (EVs), as defined in the primary outcome, and the occurrence of other morbidities before discharge, defined as:

    • Necrotizing enterocolitis
    • Bronchopulmonary dysplasia
    • Other significant conditions

    Measured: Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection. Clinical informations (occurence of other morbidity): through study completion, up to 1year.

  2. Correlation between obstetric characteristics and causes of prematurity and characterization of venous cord blood EVs.

    This secondary outcome will explore the correlation between the characterization of venous cord blood extracellular vesicles (EVs), as defined in the primary outcome, and the obstetric characteristics and causes of prematurity

    Measured: Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection. Clinical informations (obstetric characteristics and causes of prematurity): through study completion, up to 1year

  3. Comparison of Arterial and Venous Extracellular Vesicles

    For the first five inclusions, an arterial blood sample will also be collected. Extracellular vesicles (EVs) from arterial and venous cord blood will be characterized for size, concentration, and cellular origin using the same methods as described for the primary outcome.

    Arterial and venous EV characteristics will then be compared.

    Measured: Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start13 Jan 2026
  3. Primary completion13 Oct 2027 (estimated)
  4. Study completion13 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
30 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07273643
Sponsor's protocol ID
RECHMPL25_0241
Acronym
VEEP
Status last verified
Feb 2026
First submitted
19 Nov 2025
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pekarkova K, Soukup J, Kostelanska M, Sirc J, Stranak Z, Holada K. Cord Blood Extracellular Vesicles Analyzed by Flow Cytometry with Thresholding Using 405 nm or 488 nm Laser Leads to Concurrent Results. Diagnostics (Basel). 2021 Jul 22;11(8):1320. doi: 10.3390/diagnostics11081320.

    PubMed 34441255

  • Hujacova A, Brozova T, Mosko T, Kostelanska M, Stranak Z, Holada K. 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. Folia Biol (Praha). 2020;66(5-6):204-211. doi: 10.14712/fb2020066050204.

    PubMed 34087976

  • Galley JD, Mar P, Wang Y, Han R, Rajab A, Besner GE. Urine-derived extracellular vesicle miRNAs as possible biomarkers for and mediators of necrotizing enterocolitis: A proof of concept study. J Pediatr Surg. 2021 Nov;56(11):1966-1975. doi: 10.1016/j.jpedsurg.2021.02.016. Epub 2021 Mar 2.

    PubMed 33785202

  • Jakkula M, Le Cras TD, Gebb S, Hirth KP, Tuder RM, Voelkel NF, Abman SH. Inhibition of angiogenesis decreases alveolarization in the developing rat lung. Am J Physiol Lung Cell Mol Physiol. 2000 Sep;279(3):L600-7. doi: 10.1152/ajplung.2000.279.3.L600.

    PubMed 10956636

  • Janer J, Andersson S, Kajantie E, Lassus P. Endostatin concentration in cord plasma predicts the development of bronchopulmonary dysplasia in very low birth weight infants. Pediatrics. 2009 Apr;123(4):1142-6. doi: 10.1542/peds.2008-1339.

    PubMed 19336373

  • Baker CD, Balasubramaniam V, Mourani PM, Sontag MK, Black CP, Ryan SL, Abman SH. Cord blood angiogenic progenitor cells are decreased in bronchopulmonary dysplasia. Eur Respir J. 2012 Dec;40(6):1516-22. doi: 10.1183/09031936.00017312. Epub 2012 Apr 10.

    PubMed 22496315

  • Borghesi A, Massa M, Campanelli R, Bollani L, Tzialla C, Figar TA, Ferrari G, Bonetti E, Chiesa G, de Silvestri A, Spinillo A, Rosti V, Stronati M. Circulating endothelial progenitor cells in preterm infants with bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2009 Sep 15;180(6):540-6. doi: 10.1164/rccm.200812-1949OC. Epub 2009 Jul 2.

    PubMed 19574444

  • Zhong XQ, Yan Q, Chen ZG, Jia CH, Li XH, Liang ZY, Gu J, Wei HL, Lian CY, Zheng J, Cui QL. Umbilical Cord Blood-Derived Exosomes From Very Preterm Infants With Bronchopulmonary Dysplasia Impaired Endothelial Angiogenesis: Roles of Exosomal MicroRNAs. Front Cell Dev Biol. 2021 Mar 25;9:637248. doi: 10.3389/fcell.2021.637248. eCollection 2021.

    PubMed 33842462

  • Lal CV, Olave N, Travers C, Rezonzew G, Dolma K, Simpson A, Halloran B, Aghai Z, Das P, Sharma N, Xu X, Genschmer K, Russell D, Szul T, Yi N, Blalock JE, Gaggar A, Bhandari V, Ambalavanan N. Exosomal microRNA predicts and protects against severe bronchopulmonary dysplasia in extremely premature infants. JCI Insight. 2018 Mar 8;3(5):e93994. doi: 10.1172/jci.insight.93994.

    PubMed 29515035

  • Schiller EA, Cohen K, Lin X, El-Khawam R, Hanna N. Extracellular Vesicle-microRNAs as Diagnostic Biomarkers in Preterm Neonates. Int J Mol Sci. 2023 Jan 30;24(3):2622. doi: 10.3390/ijms24032622.

    PubMed 36768944

  • Menon R, Shahin H. Extracellular vesicles in spontaneous preterm birth. Am J Reprod Immunol. 2021 Feb;85(2):e13353. doi: 10.1111/aji.13353. Epub 2020 Oct 12.

    PubMed 32975858

  • Farrelly R, Kennedy MG, Spencer R, Forbes K. Extracellular vesicles as markers and mediators of pregnancy complications: gestational diabetes, pre-eclampsia, preterm birth and fetal growth restriction. J Physiol. 2023 Nov;601(22):4973-4988. doi: 10.1113/JP282849. Epub 2023 May 8.

    PubMed 37070801

  • Tesse A, Meziani F, David E, Carusio N, Kremer H, Schneider F, Andriantsitohaina R. Microparticles from preeclamptic women induce vascular hyporeactivity in vessels from pregnant mice through an overproduction of NO. Am J Physiol Heart Circ Physiol. 2007 Jul;293(1):H520-5. doi: 10.1152/ajpheart.01094.2006. Epub 2007 Mar 16.

    PubMed 17369461

  • Bravo MC, Lopez-Ortego P, Sanchez L, Riera J, Madero R, Cabanas F, Pellicer A. Randomized, Placebo-Controlled Trial of Dobutamine for Low Superior Vena Cava Flow in Infants. J Pediatr. 2015 Sep;167(3):572-8.e1-2. doi: 10.1016/j.jpeds.2015.05.037. Epub 2015 Jun 24.

    PubMed 26116470

  • Elsayed Y, Ahmed F. Blood pressure normative values in preterm infants during postnatal transition. Pediatr Res. 2024 Feb;95(3):698-704. doi: 10.1038/s41390-023-02788-8. Epub 2023 Sep 4.

    PubMed 37667035

Questions about this trial

What is this clinical trial studying?

An observational study of Intraventricular Hemorrhage and Pulmonary Hemorrhage, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between occurence of early severe morbidity mortality and characterization of Extracellular vesicles (EVs) (time frame: Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection. Clinical informations(occurence of early severe morbidity and mortality): through study completion, up to 1year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07273643, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in