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

NCT03403062 | Unknown

• 1 other identifier: RDW and neonatal sepsis
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neonatal SEPSIS

Keywords

Sepsis; red cell distribution width (RDW); Late onset sepsis (LOS); Early onset sepsis (EOS)

Outcome Measures

Primary Outcomes (1)

• the neonatal mortality rate .

  Number of neonates died from sepsis .

  30 day

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (21)

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MeSH Terms

Conditions

Neonatal Sepsis; Sepsis

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

Study Officials

• Mariam N Gamil, resident

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam N Gamil, Resident

CONTACT

00201285508913; mnga_15@yahoo.com

Amira MH Shalaby, Dr

CONTACT

00201223958949; Shalaby406.as@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: January 18, 2018
• Study Start: February 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: January 11, 2019

Record last verified: 2019-01