NCT01539356

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 16, 2016

Status Verified

November 1, 2012

Enrollment Period

11 months

First QC Date

February 21, 2012

Last Update Submit

March 15, 2016

Conditions

Preterm InfantsAnemia of PrematurityNeonatal Sepsis

Keywords

HepcidinPreterm InfantsAnemiaSepsisFerritin

Outcome Measures

Primary Outcomes (1)

  • Increase in Hepcidin levels by 30%

    within 24-72 h

Study Arms (1)

preterm infants

preterm infants receiving blood transfusion preterm infants with neonatal sepsis.

Eligibility Criteria

Age24 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm \< 38 weeks gestation Need of blood transfusion according to local Protocol. or signs and symptoms of sepsis

You may qualify if:

  • Preterm \< 38 weeks gestation
  • Need of blood test for anemia or suspected sepsis

You may not qualify if:

  • Major congenital anomalies
  • Birth Asphyxia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit

Kfar Saba, 44281, Israel

Location

Related Publications (2)

  • 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.

    PMID: 22284565BACKGROUND

  • Yapakci 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.

    PMID: 19405934BACKGROUND

MeSH Terms

Conditions

AnemiaNeonatal SepsisSepsis

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2013

Study Completion

August 1, 2013

Last Updated

March 16, 2016

Record last verified: 2012-11

Locations

IL(1)