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

NCT00800449 | Completed DMC

• 1 other identifier: PTSH001
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Sepsis

Keywords

Haptoglobin; sepsis; premature babies

Eligibility Criteria

• Age: 24 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pre-term neonates with serious congenital defects.

Sponsors & Collaborators

• Irina Kessel: lead
• Carmel Medical Center: collaborator
• Technion, Israel Institute of Technology: collaborator

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hp phenotype in blood test.

MeSH Terms

Conditions

Neonatal Sepsis; Sepsis; Premature Birth

Condition Hierarchy (Ancestors)

Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Irena Kessel, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 30, 2008
• First Posted: December 2, 2008
• Study Start: August 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

IL (1)