Clinical Trials Logo

Clinical Trial Summary

The aim of our study was to find the frequency of thrombocytopenia and its severity in neonates with sepsis


Clinical Trial Description

Early-onset sepsis remains a common and serious problem for neonates, especially preterm infants. Group B streptococcus (GBS) is the most common etiologic agent, while Escherichia coli is the most common cause of mortality. Current efforts toward maternal intrapartum antimicrobial prophylaxis have significantly reduced the rates of GBS disease but have been associated with increased rates of Gram negative infections, especially among very-low-birth-weight infants . The diagnosis of neonatal sepsis is based on a combination of clinical presentation, the use of nonspecific markers, including C-reactive protein, blood cultures, CBC , ESR. .Its miles assessed that sepsis develops in 20% of neonates, of which 1% die in the early days... Empirical treatment should be based on local patterns of antimicrobial resistance but typically consists of the use of ampicillin and gentamicin or ampicillin and cefotaxime if meningitis is suspected, until the etiologic agent has been identified. Current research is focused primarily on development of vaccines against GBS. It encompasses various systemic infections of the newborn such as septicemia, meningitis, pneumonia, pyogenic arthritis, osteomyelitis and urinary tract infections. Sepsis is the commonest cause of neonatal mortality; it is responsible for about 30-50% of the total neonatal deaths in developing countries. It is estimated that up to 20% of neonates develop sepsis and approximately 1% die of sepsis related causes. Sepsis related mortality is largely preventable with rational antimicrobial the rapid and aggressive supportive care . . Based on the onset, sepsis is divided into three categories: early-onset sepsis (fewer than three days of age), late-onset sepsis (LOS) (at 3-28 days of age), and late late-onset sepsis (at 29-120 days of age). Among all three types, late-onset sepsis (LOS) is frequent, particularly in VLBW neonates. One of the early indicators for neonatal sepsis is thrombocytopenia . Thrombocytopenia is one of the most common hematological disorders at newborn age, affecting the majority of neonates admitted to the NICU . Neonates admitted to NICUs develop thrombocytopenia in 20%-35% of all admissions, and a hike in percentage is noted with a drop in gestational age . The majority of neonates present with mild to moderate thrombocytopenia. Sepsis in the newborn is one of the chief causes of thrombocytopenia in neonates, and it can become very severe and can increase the risk of bleeding within 24 hours after developing an infection . The exact mechanism of low platelets in neonatal sepsis is unknown, but it has been proposed that sepsis causes endothelial injury, which in turn triggers the reticuloendothelial system. Platelet consumption exceeds production and causes thrombocytopenia . Thrombocytopenia and neonatal sepsis associations have been highlighted by recognizing thrombocytopenia as the prominent key risk feature for sepsis-related fatalities in neonates . An observational study by Noreen et al. showed that the frequency of thrombocytopenia is higher in neonates admitted to the NICU for any reason . Neonatal sepsis must not be considered as a homogenous entity, as it spurns both the pathogenic and clinical variations among numerous causative microorganisms and clinical syndromes and features of septicemia. No local study has been done in the recent past that emphasizes the incidence of thrombocytopenia in neonatal sepsis. In this research, we will present the characteristics of thrombocytopenia related to sepsis in both gram-negative and gram-positive cells. This will be beneficial for early diagnosis and treatment, predicting morbidity and mortality. The results of this study will provide us with local statistics on the magnitude of neonatal thrombocytopenia in sepsis, and this will provide a window for further research ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05692128
Study type Observational
Source Assiut University
Contact Ragab M Amin, Resident p
Phone +201092856285
Email ragab.aaamin@gmail.com
Status Not yet recruiting
Phase
Start date September 2023
Completion date March 2024

See also
  Status Clinical Trial Phase
Completed NCT00942084 - A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo) Phase 1
Completed NCT06002295 - A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns Phase 2
Not yet recruiting NCT05114057 - Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI N/A
Recruiting NCT04528251 - Comparison of the Effectiveness of Two Different Antibiotic Regimens of the Treatment of Pregnant Women With Preterm Rupture of Membranes
Active, not recruiting NCT03871491 - Azithromycin-Prevention in Labor Use Study (A-PLUS) Phase 3
Completed NCT03746743 - Severity Index of Neonatal Septicemia Using Score for Neonatal Acute Physiology (SNAP) II
Completed NCT02386592 - Prevention of Nosocomial Bacteremia Among Zambian Neonates N/A
Not yet recruiting NCT06113653 - Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis
Completed NCT03199547 - Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death Phase 3
Completed NCT02147327 - Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities N/A
Completed NCT01005589 - CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis N/A
Completed NCT00866567 - Defects in Opsonophagocytosis in Premature Infants N/A
Completed NCT02281890 - Neurodevelopmental Outcomes After Suspected or Proven Sepsis: Secondary Analysis of INIS Trial Database N/A
Suspended NCT05156333 - Probiotics and GBS Colonization in Pregnancy N/A
Recruiting NCT05127070 - Evaluating the NeoTree in Malawi and Zimbabwe
Completed NCT03755635 - Neonatal Sepsis at Neonatal Intensive Care Units in Ghana N/A
Completed NCT03247920 - Reduction of Intravenous Antibiotics In Neonates Phase 4
Completed NCT03295162 - Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis Phase 1/Phase 2
Completed NCT02954926 - Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis Phase 3
Withdrawn NCT01723501 - Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing <1500 g at Birth Phase 2/Phase 3