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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03403062
Recruitment Status : Not yet recruiting
First Posted : January 18, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
mariam nagy gamil, Assiut University

Brief Summary:
  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 .

Condition or disease
Neonatal SEPSIS

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostic Value of Red Cell Distribution Width (RDW) in Neonatal Sepsis in Patients Admitted at Assiut University Children Hospital.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis




Primary Outcome Measures :
  1. the neonatal mortality rate . [ Time Frame: 30 day ]
    Number of neonates died from sepsis .



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403062


Contacts
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Contact: Mariam N Gamil, Resident 00201285508913 mnga_15@yahoo.com
Contact: Amira MH Shalaby, Dr 00201223958949 Shalaby406.as@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Mariam N Gamil, resident Assiut University
Publications:

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Responsible Party: mariam nagy gamil, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03403062    
Other Study ID Numbers: RDW and neonatal sepsis
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by mariam nagy gamil, Assiut University:
Sepsis
red cell distribution width (RDW)
Late onset sepsis (LOS)
Early onset sepsis (EOS)
Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases