Early Diagnosis of Neonatal Sepsis

Sepses, Neonatal Clinical Trial

Official title:

Early Diagnosis of Neonatal Sepsis Using Modified Hematological Scoring System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04105413
• Other study ID #: EDONS
• Status: Not yet recruiting
• Start date: September 30, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 30, 2021
• Est. primary completion date: September 30, 2020
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepses, Neonatal
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• Blood culturs
CBC, Blood culture and CRP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Rodwell RL, Leslie AL, Tudehope DI. Early diagnosis of neonatal sepsis using a hematologic scoring system. J Pediatr. 1988 May;112(5):761-7. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early detection of neonatal sepsia	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