Prognostic Value of Red Cell Distribution Width (RDW) in Neonatal Sepsis

January 10, 2019 updated by: mariam nagy gamil, Assiut University

Prognostic Value of Red Cell Distribution Width (RDW) in Neonatal Sepsis in Patients Admitted at Assiut University Children Hospital.

  1. Evaluate the relationship of RDW and severity and mortality in patients with neonatal sepsis .
  2. Using RDW as a simple, inexpensive, applicable and rapid test to detect prognosis of neonatal sepsis .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Sepsis is defined as a life-threatening condition caused by a dysregulated host response to infection. Sepsis is responsible for approximately 45% of neonatal emergencies and is a leading cause of neonatal mortality and morbidity, accounting for 14% of deaths in that age group.

The early symptoms and signs of neonatal sepsis are usually mild and nonspecific but can rapidly progress to septic shock, disseminated intravascular coagulation(DIC), and death. It is therefore of paramount importance to find a tool for prediction of infants who are more likely to experience a worse clinical outcome so that closer monitoring and more aggressive treatment would be offered to them.

Early-onset sepsis (EOS) is usually due to transplacental, ascending, or intrapartum transmission in the perinatal period shortly before or during birth, up to postnatal (PN) 7 days. Late-onset sepsis (LOS) is acquired by horizontal transmission in the home, hospital, or in the community after PN day.

Timely diagnosis and prompt institution of antimicrobial therapy are essential in order to mitigate the high case fatality and to avert morbidity associated with late-onset neonatal sepsis. In the latest years, biochemical markers are important in research areas in neonatal infections. Inflammatory cascade as response to an infection comprise many elevated markers, frequently used for diagnosis and monitoring of sepsis.

Numerous molecules have been studied as potentially useful prognostic markers in neonatal sepsis. These include C-reactive protein (CRP), procalcitonin, IL-6, IL-8, CD64, and soluble E- selectin.

The red cell distribution width (RDW) is a marker, which has been studied in neonatal sepsis. The RDW is a measure of variability of red blood cells in size (anisocytosis) and is routinely evaluated as a part of complete blood count. The RDW may be elevated in conditions of ineffective production, or increased destruction of red blood cells, which commonly occur in inflammatory or infectious situations.

Red cell distribution width has been classically used as a screening index for iron deficiency anemia. However, a growing body of evidence indicates that this simple marker can have a role in predicting adverse outcome in sepsis as well as in diverse clinical situations, including coronary artery disease, heart failure,acute pancreatitis, malignancy, infective endocarditis, peritoneal dialysis, and in critically ill children in general.

The pathophysiology of the elevation of RDW in these patients is not well known, but it has been reported that elevated RDW is associated with inflammatory markers such as C-reactive protein (CRP), erythrocyte sedimentation rate, interleukin-6 and tumor necrosis factor-alpha. Proinflammatory cytokines of sepsis have been shown to suppress the maturation of red blood cells (RBC) and decrease the half-life of RBCs, resulting in the elevation of RDW values Most previous studies investigating the prognostic value of RDW were conducted on adult patients, and similar studies in neonatal sepsis are rare and small. The objective of the present research is to investigate the prognostic role of this routinely available marker in full term neonates with sepsis and to compare it with other traditional prognostic biomarkers.

The prognostic potential of RDW is of particular interest because it is routinely included in the automated complete blood count (CBC) analyses in hospitalized patients and thus available and no additional cost for clinicians.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mariam N Gamil, Resident
  • Phone Number: 00201285508913
  • Email: mnga_15@yahoo.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 month (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

- Any infant from birth to 1 month of age with a diagnosis of definite or probable sepsis will included in the study. A diagnosis of definite sepsis is made when a pathogenic agent is isolated from the blood or cerebrospinal fluid in the presence of clinical signs suggestive of sepsis. Probable sepsis is diagnosed when positive cultures are lacking in the presence of signs suggestive of sepsis and 2 positive screening parameters (abnormal CRP, erythrocyte sedimentation rate, platelet count, total leucocytic count, absolute neutrophilic count, or immature/total neutrophils ratio >0.2). When signs of sepsis are existent but both sepsis screening parameters and cultures are negative, this is deemed no sepsis

Description

Inclusion Criteria:

  • Any infant from birth to 1 month of age with a diagnosis of definite or probable sepsis will included in the study.

Exclusion Criteria:

  • gestational age less than 37 weeks.

    • perinatal asphyxia.
    • infants with more than 1 episode of sepsis, only the first one was included.
    • Infants with Dysmorphic features suggestive of chromosomal abnormalities.
    • neonates under a course of antibiotics prior to appropriate blood sampling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the neonatal mortality rate .
Time Frame: 30 day
Number of neonates died from sepsis .
30 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mariam N Gamil, resident, Assiut University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RDW and neonatal sepsis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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