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Neonatal Sepsis clinical trials

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NCT ID: NCT03932123 Recruiting - Clinical trials for Early Onset Neonatal Sepsis

Antibiotic Therapy for Early Onset Neonatal Sepsis

Start date: May 5, 2019
Phase:
Study type: Observational

Antibiotic therapy for early onset neonatal sepsis recommended by international guidelines and relevant studies is only kind of treatment regimen that penicillin G/ penicillin/ampicillin combined with gentamicin as the first-line treatment regimen. However, it is not applicable to the clinical practice in many countries and regions. We aim to study efficacy and safety of antibiotics in the treatment of early onset neonatal sepsis.

NCT ID: NCT03896893 Recruiting - Prematurity Clinical Trials

Neonatal Bacterial Colonization Study

Start date: March 4, 2019
Phase: N/A
Study type: Interventional

This study will evaluate the effect of skin antisepsis and/or emollient therapy on bacterial colonization dynamics in very low birth weight, hospitalized infants. Bacterial swabs from 5 body sites will be collected at baseline, day 3, day 8 and day 13 following study arm assignment. Study outcomes include changes in bacterial colony counts, burden of gram-negative and gram-positive pathogens and overall skin score.

NCT ID: NCT03819192 Recruiting - Clinical trials for Early-Onset Neonatal Sepsis

Predicting EONS in PPROM Patients

PEONS
Start date: February 1, 2019
Phase:
Study type: Observational

An EONS occurred in nearly 14-22 % of the preterm infant of pregnant women with PPROM. To this day no risk prediction is established. The main aim of this pilot study is generating primary data with a focus on the vaginal microbiome to set-up a prospective, multi-centre trial investigating the role of the vaginal microbiome for future EONS risk prediction. The planned PEONS pilot trial is subdivided in three Work packages: 1. Recruitment, sample collection and routine clinical diagnostics 2. Microbiome analysis by 16S rRNA 3. Microbiome/ Metagenome analysis by "Nanopore" (proof-of-principle) and will enroll women with a PPROM event hospitalized between 22+0 and 34+0 weeks of gestation and neonates with signs of EONS (Subgroup 1) and without signs of EONS (Subgroup 2).

NCT ID: NCT03777670 Recruiting - Sepsis Clinical Trials

nSeP: Detecting Neonatal Sepsis by Immune-Metabolic Network Analysis

nSeP
Start date: February 26, 2020
Phase:
Study type: Observational

Diagnosis of neonatal sepsis remains a challenge due to non-specific signs and diagnostic inaccuracies. Studies have shown that this could lead to overdiagnosis and overuse of antibiotic treatment, with potential long-term adverse effects. A systems approach towards diagnosing neonatal sepsis has been shown to have high accuracy in initial studies. This study aims to recruit a large validation cohort to confirm findings.

NCT ID: NCT03634891 Recruiting - Clinical trials for Neonates Have Risk Factors or Manifestations of Sepsis

An Audit Study on Management of Neonates With Neonatal Sepsis Admitted to Asyut University Children Hospital

ASMNWNSATAUC
Start date: June 1, 2018
Phase:
Study type: Observational [Patient Registry]

The present study aims to evaluate management of neonates with neonatal sepsis admitted to the Neonatology Unit, Assiut University Children Hospital according to the guidelines of the American Academy of Pediatrics, 2018,[25] searching for defects, obstacles, or needs to improve the management of such cases. We consider that this critical appraisal of our own performance, is a crucial step before any further corrections or developments of that performance could take place.

NCT ID: NCT03578978 Recruiting - Clinical trials for Necrotizing Enterocolitis

A Panel of Biomarkers in Diagnosing Late-onset Neonatal Sepsis and Necrotizing Enterocolitis in Sibu Hospital

PISALONS
Start date: July 1, 2018
Phase:
Study type: Observational

This is a cross-sectional study to evaluate the utilities of a panel of biomarkers (Procalcitonin, Interleukin-6, Serum Amyloid A and Apolipoprotein C2) versus the gold standard blood culture result diagnosing late-onset neonatal sepsis (LONS) and/or necrotizing enterocolitis (NEC). Neonates who meet the initial screening criteria for suspected LONS or NEC will be recruited into the study. A group of 50 neonates who are clinically well, admitted to the nursery or general ward for reasons other than neonatal sepsis or NEC will also be recruited into the study.

NCT ID: NCT03431558 Recruiting - Clinical trials for Necrotizing Enterocolitis

Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies.

Start date: May 1, 2018
Phase: Phase 3
Study type: Interventional

Pakistan has the third highest number of neonatal deaths worldwide. During the last two decades (1990-2013), neonatal mortality rate in the country has declined by only 1.0% per year. Severe infection is the second most leading cause of neonatal mortality, account for 28% of all deaths in Pakistan. Majority of neonatal deaths occur in infants who LBW (birth weight <2500g) and LBW comprises of both preterm / small for gestational age newborns. Breastfeeding helps protect infants from infections by serving as a source of nutrition uncontaminated by environmental pathogens. The protection is due to the multiple anti-infective, anti-inflammatory, and immuno regulatory factors transmitted through milk including secretory antibodies, glycan's, Lactoferrin, leukocytes, cytokines & other components produced by the mother's immune system. Reduction in neonatal infections and deaths is the aim of this study. The study is being conducted at the Aga Khan University in collaboration with University of Sydney.