Study of Erythropoietin in Newborns and Children

Newborn Infant Clinical Trial

— EPO  

Official title:

Study of Erythropoietin in Newborns and Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03957863
• Other study ID #: Girodon 2018
• Status: Recruiting
• Start date: March 12, 2019
• Est. completion date: March 2020

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: François Girodon
• Phone: 03.80.29.30.47
• Email: francois.girodon[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Under One Year of Age
• Newborn Infant

Intervention

Biological:
• Plasma collection for EPO assay
Plasma collection for EPO assay

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPO concentration UI/L		Baseline
Primary	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