Newborn InfantEPONCT03957863
Study of Erythropoietin in Newborns and Children
An observational study of Newborn Infant and Child Under One Year of Age, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Newborn Infant, Child Under One Year of Age
- What is being tested?
- Plasma collection for EPO assay
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2019to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: newborn or child under 1 year of age
Who may be able to join
- infant or child under 1 year old hospitalized or consulting at CHU Dijon Bourgogne whose parents have not opposed participation in the study
Who cannot join
- child treated with recombinant erythropoietin
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
François Girodon, 03.80.29.30.47 ext. +33, francois.girodon@chu-dijon.fr
About this study
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.
Read more
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.
- Conditions
- Newborn Infant, Child Under One Year of Age
- Being tested
- Plasma collection for EPO assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma collection for EPO assayBiological
Plasma collection for EPO assay
What is being measured
The primary outcome is the main question the study is designed to answer.
EPO concentration UI/L
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start12 Mar 2019
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newborn InfantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957863
- Sponsor's protocol ID
- Girodon 2018
- Acronym
- EPO
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 21 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40305710
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Erythropoietin in Newborns and Children
- ClinicalTrials.gov ID
- NCT03957863
- Acronym / sponsor ID
- EPO / Girodon 2018
- Conditions
- Newborn Infant, Child Under One Year of Age
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- newborn or child under 1 year of age
Key inclusion criteria (1 listed)
- infant or child under 1 year old hospitalized or consulting at CHU Dijon Bourgogne whose parents have not opposed participation in the study
Key exclusion criteria (1 listed)
- child treated with recombinant erythropoietin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma collection for EPO assayPlasma collection for EPO assay | Biological | – |
Primary outcome
EPO concentration UI/L
Time frame: Baseline
Electrophoretic profile of EPO
Time frame: Baseline
It is an indicator of glycosylation differences (more complex forms including sialic acids are more acidic, less complex forms are more basic)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 40305710Martin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Infant and Child Under One Year of Age, run by Centre Hospitalier Universitaire Dijon 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Girodon (03.80.29.30.47 ext. +33, francois.girodon@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EPO concentration UI/L (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT03957863, which also lists 1 linked publication.
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 21 May 2019.