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Neonatal SepsisNCT00800449

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

An observational study of Neonatal Sepsis, run by Irina Kessel at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 24 to 35 weeks
Conditions the study is for
Neonatal Sepsis
How many people
133 participants
Where
1 siteIsrael
Study dates
Aug 2007to Sep 2011
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 35 weeks
  • All sexes
  • No healthy volunteers
  • Child

Study population: All preterm neonates ( a total of 150 preterm babies, 35 weeks or younger) admitted to the NICU in Carmel hospital.

Who may be able to join

  • 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.

Who cannot join

  • Pre-term neonates with serious congenital defects.

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Carmel Medical Center

    Haifa, 34362

Other trials in Israel

About this study

Official title: Prospective Assessment of the Distribution of Haptoglobin Phenotype in Septic and Non Septic Pre-term Neonates (PTSH)

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.

Read more

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.

Read the detailed description

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. Hp 2 allele DM individuals have larger myocardial infarctions than homozygous Hp 1 DM individuals. This may be due to differences in the antioxidant and anti-inflammatory properties of these proteins.The same phenomenon was demonstrated in a murine coronary ischemia-reperfusion model.

The Haptoglobin is an acute phase protein with anti-oxidant, bacteriostatic and anti-inflammatory functions.

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 .

We proposed that in individuals homozygous for the Haptoglobin 1 allele (1-1 genotype), the streptococcal infection would be more severe than in individuals with the Haptoglobin 2 allele (2-1 or 2-2 genotype).

During a severe outbreak of impetigo in two infantry units in the Israeli Defense Forces, over 60% (57/91) of the soldiers developed impetigo caused by a single pathogen-group A streptococcus. 33% of them developed serious life-threatening complications requiring hospitalization. The risk of Haptoglobin 1-1 genotype individuals developing severe infection was significantly higher than individuals with Haptoglobin 2 genotype (45.5% (5/11) vs. 17.5% (14/80), risk ratio 2.6 (95% confidence interval 1.2-5.8), p=0.05). This supports the notion that the Haptoglobin genotype determines the susceptibility to streptococcus infection, an important pathogen early in human evolution, and explains the spread of Haptoglobin 2 allele in human.

Another study demonstrated that Diabetic dialysis patients at the age of 60 and above carrying the Hp1-1 phenotype had a lower mortality rate compared to the patients who are Hp2-2. However, younger population has shown the opposite. This can be explained by the survivorship pattern of Hp1-1 diabetic patients who have lower risk for diabetic complications. They will also survive dialysis in older age by suffering less from vascular complications compared to Hp2-2. However, in Hp2-2 younger patients, the infectious parameter is more significant and mortality will be lower.

We 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.

During the study period of one year, all preterm neonates (a total of 150 preterm babies, 35 weeks or younger) admitted to the preterm unit at Carmel hospital will be typed for Hp phenotype by a blood test. Hp phenotyping needs only about 500 microliters of blood which will be taken during routine blood drawn. All blood samples will be identified with the patient's I.D. number and name in addition to the study consecutive serial number. The blood samples will be sent to the laboratory of vascular medicine in the faculty of medicine at the Technion. If the number of participating infants during one year will be insufficient (less than 150), we will ask for additional permission of the ethical committee to continue the study for the second year.

Septic neonates will be recognized by clinical deterioration (abnormal body temperature and/or disturbed skin perfusion and/or apathy and/or increase in apnea/bradycardia episodes and/or abnormal CBC, leukocytosis or leucopenia or left shift or thrombocytopenia) and concomitant positive blood cultures, without another explanation of non infectious etiology. Details of the bacteria including antibiotic resistance profile will be documented. Demographic data will be collected for all patients.

In addition data regarding known pre-maturity complications such as Retinopathy of Pre-maturity (ROP), Necrotizing Entero-Colitis (NEC), Broncho-Pulmonary Dysplasia (BPD) will be assessed and documented according to the admission summary.

Blood transport, Hp typing and data collection will be done by a MD student as part of her MD thesis.

As part of the informed consent, we will ask the permission for a possible follow up one year after discharge from the hospital which will be done by a phone questionnaire and acquiring the patients medical file data with the help of his family

Conditions
Neonatal Sepsis
Keywords
Haptoglobin, sepsis, premature babies
Medical subject headings
Neonatal Sepsis, Sepsis, Premature Birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2008 (estimated)
  2. Study startAug 2007
  3. Primary completionMar 2011
  4. Study completionSep 2011

Resources

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
Cohort
Time perspective
Prospective
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00800449
Sponsor's protocol ID
PTSH001
Status last verified
Feb 2012
First submitted
30 Nov 2008
Last updated
14 Feb 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Neonatal Sepsis, run by Irina Kessel 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 1 inclusion and 1 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 14 Feb 2012. 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.

Where can I read the original study information?
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 14 Feb 2012.

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