- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04105413
Early Diagnosis of Neonatal Sepsis
September 24, 2019 updated by: Fady Magdy Saber, Assiut University
Early Diagnosis of Neonatal Sepsis Using Modified Hematological Scoring System
Sepsis is defined as a systemic inflammatory response syndrome (SIRS) associated with infection diagnosed either on microbiologic cultures or strong clinical evidence of an infection.
Study Overview
Detailed Description
Sepsis is defined as a systemic inflammatory response syndrome (SIRS) associated with infection diagnosed either on microbiologic cultures or strong clinical evidence of an infection..Worldwide, neonatal sepsis is responsible for 4 million deaths annually and 99% of them occur in developing countries.. .
morbidity associated with sepsis includes sensorineural hearing loss, visual disturbances, seizures, and neurodevelopmental issues.. Blood culture is considered as gold standard for diagnosis of sepsis.
The ideal diagnostic test should be inexpensive, have quick results Hematologic scoring system(HSS) of Rodwell et al. includes the following: a) White blood cell and platelet count b) White blood differential count c) Nucleated red blood cell count (to correct WBC count) d) Assessment of neutrophil morphology for degenerative changes.
A modified HSS(modified hematological scoring system) was developed by removing the repetitive parameters, adding a new parameter - nucleated RBC.
Study Type
Observational
Enrollment (Anticipated)
100
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 4 weeks (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all neonates suspected neonatal sepsis
Description
Inclusion Criteria:
- Newborns with history of prolonged rupture of membranes, maternal intrapartum fever or non specific signs of sepsis namely; neonatal fever or hypothermia , poor feeding ,lethargy, irritability, depressed neonatal reflexes ,respiratory distress including apnea or cyanosis,hypoxia,poor capillary perfusion,bradycardia,hypotension,pallor,edema,vomiting,diarrhea,abdominal distention, bulging anterior fontanelle,coma,seizures,unexplained jaundice, reduced suckling, bleeding problems,hypoglycemia,hyperglycemia or metabolic acidosis were included in the study
Exclusion Criteria:
- All the newborn babies with history of delayed cry, meconium aspiration, congenital anomaly, history of antibiotics administration prior to admission to the baby or mother, intrapartum and neonatal death in sibling with similar presentation will be excluded
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 |
---|---|---|
Early detection of neonatal sepsia
Time Frame: average 1 year
|
To determine the accuracy of a simple and cost effective Modified hematological scoring system in the early diagnosis of neonatal sepsis using blood culture as a gold standard in neonates attending Neonatology Unit of Assiut University Children Hospital
|
average 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Wynn J, Cornell TT, Wong HR, Shanley TP, Wheeler DS. The host response to sepsis and developmental impact. Pediatrics. 2010 May;125(5):1031-41. doi: 10.1542/peds.2009-3301. Epub 2010 Apr 26.
- Darmstadt GL, Saha SK, Choi Y, El Arifeen S, Ahmed NU, Bari S, Rahman SM, Mannan I, Crook D, Fatima K, Winch PJ, Seraji HR, Begum N, Rahman R, Islam M, Rahman A, Black RE, Santosham M, Sacks E, Baqui AH; Bangladesh Projahnmo-2 (Mirzapur) Study Group. Population-based incidence and etiology of community-acquired neonatal bacteremia in Mirzapur, Bangladesh: an observational study. J Infect Dis. 2009 Sep 15;200(6):906-15. doi: 10.1086/605473.
- Mishra UK, Jacobs SE, Doyle LW, Garland SM. Newer approaches to the diagnosis of early onset neonatal sepsis. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F208-12. doi: 10.1136/adc.2004.064188.
- Rodwell RL, Leslie AL, Tudehope DI. Early diagnosis of neonatal sepsis using a hematologic scoring system. J Pediatr. 1988 May;112(5):761-7. doi: 10.1016/s0022-3476(88)80699-1.
- Mikhael M, Brown LS, Rosenfeld CR. Serial neutrophil values facilitate predicting the absence of neonatal early-onset sepsis. J Pediatr. 2014 Mar;164(3):522-8.e1-3. doi: 10.1016/j.jpeds.2013.10.080. Epub 2013 Dec 10.
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)
September 30, 2019
Primary Completion (Anticipated)
September 30, 2020
Study Completion (Anticipated)
April 30, 2021
Study Registration Dates
First Submitted
September 24, 2019
First Submitted That Met QC Criteria
September 24, 2019
First Posted (Actual)
September 26, 2019
Study Record Updates
Last Update Posted (Actual)
September 26, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDONS
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.
Clinical Trials on Sepses, Neonatal
-
prof. dr. Frans B. PlötzDutch Society of Pediatrics; Zorgevaluatie Nederland; Care4Neo; everywhereIMRecruitingEOS | Early-Onset Sepsis, NeonatalNetherlands
-
Mednax Center for Research, Education, Quality...Banner University Medical CenterCompletedMaternal; Chorioamnionitis, Affecting Fetus | Early-Onset Sepses, NeonatalUnited States
-
Fakultas Kedokteran Universitas IndonesiaUnknownEnterocolitis, Necrotizing | Retinopathy of Prematurity | Bronchopulmonary Dysplasia | Early-Onset Sepses, Neonatal | Small for Gestational Age Infant | Periventricular Haemorrhage Neonatal
-
King George's Medical UniversityIndian Council of Medical ResearchCompletedNeonatal Morbidity | Neonatal IllnessesIndia
-
Guangzhou Women and Children's Medical CenterRecruitingNeonatal Hyperbilirubinemia | Neonatal Jaundice | Hemolysis NeonatalChina
-
University of AarhusCompletedUncomplicated Neonatal HyperbilirubinemiaDenmark
-
HonorHealth Research InstituteNeolightCompletedNeonatal Hyperbilirubinemia | Jaundice, Neonatal | Neonatal DisorderUnited States
-
National Liver Institute, EgyptCompleted
-
University College, LondonMinistry of Health and Child Welfare, Zimbabwe; Biomedical Research and Training... and other collaboratorsRecruitingNeonatal Encephalopathy | Prematurity | Neonatal Seizure | Neonatal Jaundice | Neonatal Sepsis | Neonatal Death | Neonatal Respiratory Failure | Neonatal Hypoglycemia | Neonatal Disorder | Neonatal HypothermiaZimbabwe, Malawi
-
Muhammad ZarkNot yet recruitingPhysiological Neonatal Jaundice | Physiological HyperbilirubinaemiaPakistan
Clinical Trials on Blood culturs
-
University of OxfordMahidol Oxford Tropical Medicine Research UnitUnknown
-
Ohio State University Comprehensive Cancer CenterRecruitingAcute Graft-versus-Host Disease | Allogeneic Stem Cell TransplantUnited States
-
Medical University of GrazJoanneum Research Forschungsgesellschaft mbHCompleted
-
University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruiting
-
Hamad Medical CorporationSidra Medical and Research Center; World Anti-Doping Agency; Anti-Doping Lab... and other collaboratorsUnknownBlood Disease | Blood Transfusion, Autologous | Blood Doping | Blood Transfusion, HomologousQatar
-
Emory UniversityWithdrawnHematopoietic and Lymphoid Cell Neoplasm | Leukemia | Anemia | Myelodysplastic Syndrome | Aplastic Anemia | Bone Marrow FailureUnited States
-
Rennes University HospitalCompletedHistory of Exposure to Silica or Asbestosis | Positive Testing for ANA as a Marker of Systemic Autoimmune DiseasesFrance
-
Emory UniversityCompleted
-
University of South AlabamaRecruitingBurns | TraumaUnited States
-
CardioRenalCompletedPotassium MeasurementBelgium