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Neonatal Infection clinical trials

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NCT ID: NCT06194396 Recruiting - Neonatal Infection Clinical Trials

Effect of Chlorhexidine Versus Alcohol on Infections in Neonates

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Chlorhexidine is a local antiseptic that has an important role in the prevention of catheter-associated bloodstream infections. Its application to a newborn's umbilical cord reduces all-cause neonatal mortality.

NCT ID: NCT05763680 Recruiting - Clinical trials for Microbial Colonization

Molecular Culture for the Diagnosis of Neonatal Sepsis

Start date: July 15, 2023
Phase:
Study type: Observational

Rationale: Early diagnosis of sepsis in neonates is complicated as the signs and symptoms are nonspecific. Although blood culture is the gold standard for the diagnosis, false-negative results and long incubation period of 36-72 hours limits the use of blood culture to rule out sepsis at initial suspicion. Since delay in diagnosis may lead to progressive deterioration, antibiotics are often started empirically at initial sepsis suspicion, awaiting results of the blood culture. Consequently, uninfected infants are often unnecessarily exposed to empirical antibiotics. To reduce unnecessary treatment of non-infected infants, an early, sensitive and specific diagnostic tool would be helpful to guide clinicians faster when to discontinue antibiotics. Molecular Culture (MC) via IS-pro is a novel, advanced, molecular culture technique which is able to culture bacteria within 4 hours after blood sampling. MC might thus be a potential diagnostic tool to detect or rule out sepsis in infants quickly, however data on MC for diagnosis of sepsis in this population is limited. Objective: The aim of this study is to evaluate whether MC is of additive predictive value for the diagnosis sepsis in this vulnerable group. Study design: Prospective observational cohort study. Study population: All infants suspected for neonatal sepsis of both early and late onset will be eligible for study participation. They will be treated according to the standard local guidelines. Intervention (if applicable): In case of a suspicion of sepsis at birth, blood will be collected for a conventional blood culture as part of standard care. Additionally, a blood sample will be collected from the umbilical cord for MC. In case of a suspicion of sepsis not directly postpartum, an additional blood sample will be taken for MC analysis, directly following sampling for conventional culture, implying no extra phlebotomy. Main study parameters/endpoints: The main study parameter is the discordance in positive and negative outcomes of MC compared to outcomes of conventional blood culture. As the diagnostic accuracy of the conventional blood culture (the current gold standard) is being questioned, the predictive value of MC versus conventional blood culture towards clinical sepsis will also be tested.

NCT ID: NCT05743816 Recruiting - Neonatal Infection Clinical Trials

Neonatal Antimicrobial Resistance and Outcome

neoAMRO
Start date: July 30, 2019
Phase:
Study type: Observational [Patient Registry]

This is a multicentre observational study involving NNUs across the UK. Study personnel (Neonatologists and research Nurses) from these NNUs will identify eligible babies in whom a positive culture has been obtained. This study will help identify the infections leading to death in babies on UK neonatal units, define the clinical characteristics of babies dying from infections, and describe the management of babies dying from infections with a specific focus in their antimicrobial treatment.

NCT ID: NCT05742490 Recruiting - Neonatal Infection Clinical Trials

Neonatal Infection Surveillance Database

neonIN
Start date: December 16, 2013
Phase:
Study type: Observational [Patient Registry]

NeonIN is a is a neonatal infection surveillance database which will facilitate active surveillance for bacterial infections through a network of neonatal units, using standardised definitions, proformas and microbiological techniques. The centralised and secure web-based database will allow real-time entry of data and rapid and timely analysis of results.

NCT ID: NCT05695196 Recruiting - Clinical trials for Microbial Colonization

Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant

ParentsTREAT
Start date: October 25, 2023
Phase: Phase 1
Study type: Interventional

This feasibility and safety pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will create a healthy, diverse neonatal nasal microbiome.

NCT ID: NCT04818762 Recruiting - Preterm Birth Clinical Trials

Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates

pFTOE
Start date: February 26, 2021
Phase:
Study type: Observational

This is a prospective observational pilot study investigating if peripheral fractional tissue oxygen extraction (pFTOE) measured by five short near-infrared spectroscopy (NIRS) (re-)applications within the first 6 hours after birth in neonates with respiratory distress differs in neonates with early onset infection and neonate without infection

NCT ID: NCT04664569 Recruiting - Children, Only Clinical Trials

National Bacterial Meningitis Study

Start date: January 1, 2001
Phase:
Study type: Observational

Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.

NCT ID: NCT04416373 Recruiting - Breastfeeding Clinical Trials

COVID-19 and Pregnancy Outcomes

COVID&PREG
Start date: March 22, 2020
Phase:
Study type: Observational

This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

NCT ID: NCT03499652 Recruiting - Neonatal Infection Clinical Trials

Neonatal Bacterial Meningitis Cohort

Start date: December 1, 2017
Phase:
Study type: Observational [Patient Registry]

Neonatal bacterial meningitis (BM) is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality, especially in developing countries. In this study, we aimed to develop a clinical risk score model, according to the available clinical syndromes and commonly laboratory tests, for screening BM among full-term neonates in a large-scale retrospective cohort, and prospectively validated the risk score in multicenter cohort.

NCT ID: NCT03371056 Recruiting - Neonatal Infection Clinical Trials

Maternal- Fetal Infection

InSPIRe
Start date: August 28, 2018
Phase: N/A
Study type: Interventional

The purpose of the protocol is to validate a novel point of care multiplex system to detect and characterize microorganisms responsible for neonatal sepsis, as well as biomarkers of infection, from a simple vaginal sample, in order to improve the prevention of perinatal bacterial infections.