Preterm InfantsNCT01539356
Hepcidin Levels in Preterm Infants
An observational study of Preterm Infants and Anemia of Prematurity, run by Meir Medical Center at 1 site in Israel.
Trial summary
A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron retention in reticuloendothelial cells. Read more about this study
- Who is it for?
- Ages 24 to 37 weeks
- Conditions the study is for
- Preterm Infants, Anemia of Prematurity, Neonatal Sepsis
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Aug 2013
- 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 24 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm < 38 weeks gestation Need of blood transfusion according to local Protocol. or signs and symptoms of sepsis
Who may be able to join
- Preterm < 38 weeks gestation
- Need of blood test for anemia or suspected sepsis
Who cannot join
- Major congenital anomalies
- Birth Asphyxia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepcidin Levels in Preterm Infants Receiving Blood Transfusion and During Sepsis.
A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron retention in reticuloendothelial cells. The aims of this study were to determine serum hepcidin levels in preterm infants who receive blood transfusion and preterm infants having sepsis, in order to assess possible relationships between hepcidin and serum iron, serum ferritin,in iron load situations.
- Conditions
- Preterm Infants, Anemia of Prematurity, Neonatal Sepsis
- Keywords
- Hepcidin, Preterm Infants, Anemia, Sepsis, Ferritin
- Medical subject headings
- Anemia, Neonatal Sepsis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| preterm infants | preterm infants receiving blood transfusion preterm infants with neonatal sepsis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Hepcidin levels by 30%
Measured: within 24-72 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539356
- Sponsor's protocol ID
- 0154-11-MMC
- Status last verified
- Nov 2012
- First submitted
- 21 Feb 2012
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller KF, Lorenz L, Poets CF, Westerman M, Franz AR. Hepcidin concentrations in serum and urine correlate with iron homeostasis in preterm infants. J Pediatr. 2012 Jun;160(6):949-53.e2. doi: 10.1016/j.jpeds.2011.12.030. Epub 2012 Jan 28.
PubMed 22284565Yapakci E, Tarcan A, Celik B, Ozbek N, Gurakan B. Serum pro-hepcidin levels in term and preterm newborns with sepsis. Pediatr Int. 2009 Apr;51(2):289-92. doi: 10.1111/j.1442-200X.2008.02688.x.
PubMed 19405934
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepcidin Levels in Preterm Infants Receiving Blood Transfusion and During Sepsis.
- ClinicalTrials.gov ID
- NCT01539356
- Acronym / sponsor ID
- 0154-11-MMC
- Conditions
- Preterm Infants, Anemia of Prematurity, Neonatal Sepsis
- Keywords
- Hepcidin, Preterm Infants, Anemia, Sepsis, Ferritin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 27 Feb 2012 (estimated)
- 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.
A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron retention in reticuloendothelial cells. The aims of this study were to determine serum hepcidin levels in preterm infants who receive blood transfusion and preterm infants having sepsis, in order to assess possible relationships between hepcidin and serum iron, serum ferritin,in iron load situations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preterm infants | – | –preterm infants receiving blood transfusion preterm infants with neonatal sepsis. |
Who may qualify
- Ages
- 24 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm < 38 weeks gestation Need of blood transfusion according to local Protocol. or signs and symptoms of sepsis
Key inclusion criteria (2 listed)
- Preterm < 38 weeks gestation
- Need of blood test for anemia or suspected sepsis
Key exclusion criteria (2 listed)
- Major congenital anomalies
- Birth Asphyxia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increase in Hepcidin levels by 30%
Time frame: within 24-72 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 22284565Muller KF, Lorenz L, Poets CF, Westerman M, Franz AR. Hepcidin concentrations in serum and urine correlate with iron homeostasis in preterm infants. J Pediatr. 2012 Jun;160(6):949-53.e2. doi: 10.1016/j.jpeds.2011.12.030. Epub 2012 Jan 28.
- Background: PubMed 19405934Yapakci E, Tarcan A, Celik B, Ozbek N, Gurakan B. Serum pro-hepcidin levels in term and preterm newborns with sepsis. Pediatr Int. 2009 Apr;51(2):289-92. doi: 10.1111/j.1442-200X.2008.02688.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Preterm Infants and Anemia of Prematurity, run by Meir Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Mar 2016. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Hepcidin levels by 30% (time frame: within 24-72 h). 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 NCT01539356, which also lists 2 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 16 Mar 2016.