ClinicalTrials.gov
ClinicalTrials.gov Menu

Distribution of Haptoglobin Phenotype in Septic and Non Septic Pre-term Neonates (PTSH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00800449
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : February 14, 2012
Sponsor:
Collaborators:
Carmel Medical Center
Technion, Israel Institute of Technology
Information provided by (Responsible Party):
Irina Kessel, Carmel Medical Center

Brief Summary:

The Haptoglobin (Hp) gene locus at chromosome 16q22 is polymorphic with two alleles denoted 1 and 2 .The gene product exists in three phenotypes: 1-1, 2-1, and 2-2.

The Haptoglobin 2 allele is found only in man and is believed to have arisen from the Haptoglobin 1 allele by a partial intragenic duplication. Haptoglobin 2 allele frequency is higher than the Haptoglobin 1 allele. It has been hypothesized that the Haptoglobin 2 allele was spread in man due to its selective advantage against life-threatening infections.

In vitro, only the Haptoglobin 2 allele protein, binds to the streptococcus T antigen, resulting in its aggregation and slowing its growth .

Individuals homozygous for the Haptoglobin 1 allele (1-1 genotype) are more prone to the streptococcal infection than individuals with the Haptoglobin 2 allele(2-1 or 2-2 genotype).

The investigators wish to explore the linkage between Hp phenotype and sepsis in pre-term neonates, considering that in this early stage in life, genetic properties which provide a defense against infectious agents will be of heightened importance.


Condition or disease
Neonatal Sepsis

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Assessment of the Distribution of Haptoglobin Phenotype in Septic and Non Septic Pre-term Neonates (PTSH)
Study Start Date : August 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources




Biospecimen Retention:   Samples Without DNA
Hp phenotype in blood test.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   24 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All preterm neonates ( a total of 150 preterm babies, 35 weeks or younger) admitted to the NICU in Carmel hospital.
Criteria

Inclusion Criteria:

  • Preterm babies born at 35 week gestational age and younger being admitted to the preterm unit in Carmel Medical Center over a period of one year.

Exclusion Criteria:

  • Pre-term neonates with serious congenital defects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800449


Locations
Israel
Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Irina Kessel
Carmel Medical Center
Technion, Israel Institute of Technology
Investigators
Principal Investigator: Irena Kessel, MD Carmel Medical Center

Responsible Party: Irina Kessel, MD, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00800449     History of Changes
Other Study ID Numbers: PTSH001
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

Keywords provided by Irina Kessel, Carmel Medical Center:
Haptoglobin
sepsis
premature babies

Additional relevant MeSH terms:
Sepsis
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases