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

Unknown

Conditions

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

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

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

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

Assiut University

Investigators

  • Principal Investigator: Mariam N Gamil, resident, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2019

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

February 1, 2020

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

January 10, 2018

First Posted (ACTUAL)

January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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