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Study of Erythropoietin in Newborns and Children

Study of Erythropoietin in Newborns and Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03957863
Acronym
EPO
Enrollment
40
Registered
2019-05-21
Start date
2019-03-12
Completion date
2020-03-31
Last updated
2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Under One Year of Age, Newborn Infant

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.

Interventions

BIOLOGICALPlasma collection for EPO assay

Plasma collection for EPO assay

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* child treated with recombinant erythropoietin

Design outcomes

Primary

MeasureTime frameDescription
EPO concentration UI/LBaseline
Electrophoretic profile of EPOBaselineIt is an indicator of glycosylation differences (more complex forms including sialic acids are more acidic, less complex forms are more basic)

Countries

France

Contacts

Primary ContactFrançois Girodon
francois.girodon@chu-dijon.fr03.80.29.30.47

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026