NCT03957863

Brief Summary

Erythropoietin (EPO) is a glycoprotein hormone with a molecular weight of 30.4 kDa, responsible for regulating erythropoiesis in adults, newborns and fetuses. During pregnancy, the concentration of maternal serum EPO increases linearly to allow for effective erythropoiesis over time. In the fetus, in the first 30 weeks of gestation, the liver is the main synthetic organ. Thereafter, there is a progressive transfer of the synthesis of EPO to the kidneys. In the long term, under normal conditions of oxygenation, the fetal synthesis of EPO is mainly ensured by the kidney. Because of the impossibility of making EPO tissue reserves and the inability of EPO to pass the placental barrier, the concentration of circulating EPO in the fetus reflects the balance between production and elimination. During the last trimester of pregnancy, in the absence of patent hypoxia, fetal concentrations of circulating EPO are between 10 and 50 mIU /ml, while in amniotic fluid the EPO is found at lower concentrations, between 2 and 20 mIU /ml. In adults, EPO synthesis is primarily renal, and incidentally hepatic, even if in certain pathological situations (end-stage kidney disease or polycystosis) the liver is able to take over and synthesize EPO with an electrophoretic profile similar to that of the EPO from the umbilical cord, but often in insufficient quantities. The objective of this study is to describe the forms of EPO in newborns and to compare possible iso-forms with those of adults.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

12 months

First QC Date

May 15, 2019

Last Update Submit

May 20, 2019

Conditions

Newborn InfantChild Under One Year of Age

Outcome Measures

Primary Outcomes (2)

  • EPO concentration UI/L

    Baseline

  • Electrophoretic profile of EPO

    It is an indicator of glycosylation differences (more complex forms including sialic acids are more acidic, less complex forms are more basic)

    Baseline

Interventions

Plasma collection for EPO assayBIOLOGICAL

Plasma collection for EPO assay

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

newborn or child under 1 year of age

You may qualify if:

  • infant or child under 1 year old hospitalized or consulting at CHU Dijon Bourgogne whose parents have not opposed participation in the study

You may not qualify if:

  • child treated with recombinant erythropoietin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

RECRUITING

Related Publications (1)

  • Martin L, Maric D, Idriss S, Delamare M, Le Roy A, Maaziz N, Caillaud A, Si-Tayeb K, Robriquet F, Lenglet M, Erceau L, Bellanne-Chantelot C, Plo I, Aral B, Garrec C, Airaud F, Gianfermi C, Antunes V, Keppner A, Vincent SM, Desfontaine A, Mode N, Laporte F, Gaignerie A, Chariau C, Leray I, Rogue C, David L, Redon R, Bezieau S, Mansour-Hendili L, Galacteros F, Maillet T, Pasquet M, Cougoul P, Nloga AM, Gardin C, Guitton C, Dubruille V, Giacobbi-Milet V, Leblanc T, Kaya Z, Semama D, James C, Carillo S, Ochmann M, Waage A, Mortier E, Maillasson M, Quemener A, Cario H, Skoda RC, Zermati Y, Hoogewijs D, Marchand A, Girodon F, Gardie B. Identification of Hepatic-like EPO as a Cause of Polycythemia. N Engl J Med. 2025 May 1;392(17):1684-1697. doi: 10.1056/NEJMoa2414954.

    PMID: 40305710DERIVED

MeSH Terms

Interventions

Erythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Central Study Contacts

François Girodon

CONTACT

03.80.29.30.47francois.girodon@chu-dijon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 21, 2019

Study Start

March 12, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

FR(1)