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

This study has been completed.
Sponsor:
Collaborators:
Carmel Medical Center
Technion, Israel Institute of Technology
Information provided by (Responsible Party):
Irina Kessel, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00800449
First received: November 30, 2008
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Neonatal Sepsis

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Biospecimen Retention:   Samples Without DNA

Hp phenotype in blood test.


Enrollment: 133
Study Start Date: August 2007
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   24 Weeks to 35 Weeks
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Irina Kessel, MD, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00800449     History of Changes
Other Study ID Numbers: PTSH001
Study First Received: November 30, 2008
Last Updated: February 13, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
Haptoglobin
sepsis
premature babies

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013