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Neonatal Infection clinical trials

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NCT ID: NCT06413056 Completed - Neonatal Infection Clinical Trials

Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection

Start date: October 20, 2022
Phase: Phase 4
Study type: Interventional

The incidence of fungal infection has increased dramatically over the past few decades.This is due to increase in survival rates of preterm neonates, advances in medical technology and drug therapy, broad spectrum antibiotics and parenteral nutrition . The resistance to antifungal agents has increased. This study will assess the efficacy of micafungin versus amphotericin B in neonates with positive fungal culture.

NCT ID: NCT06283355 Not yet recruiting - Clinical trials for Microbial Colonization

Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome

Start date: August 1, 2024
Phase: Phase 1
Study type: Interventional

This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.

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: NCT06102044 Not yet recruiting - Neonatal Infection Clinical Trials

Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Start date: June 30, 2024
Phase: Phase 3
Study type: Interventional

Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection. The Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.

NCT ID: NCT05813184 Not yet recruiting - Dysbiosis Clinical Trials

Prenatal Antibiotics and Breast Milk / Neonatal IgA

PAIGAN 1
Start date: April 30, 2023
Phase:
Study type: Observational

In this biological study, we will evaluate the levels of breast milk IgA, neonatal fecal IgA, and the composition of breast milk and fecal microbiota throughout the first 12 months of life in neonates born to mothers treated or not treated with prenatal antibiotics for at least 7 days after the 32nd weeks of gestation

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: NCT05717283 Completed - Clinical trials for Microbial Colonization

Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology.

NEOBIOME
Start date: December 20, 2022
Phase: N/A
Study type: Interventional

The goal of this interventional study is to learn about nasal microbiome and viral infections in newborns hospitalised in neonatology. The main questions it aims to answer are : - how often are newborns infected by viruses in neonatology ? - how does the microbiome develop during first weeks of life ? - how does microbiome and viruses interacts together ? - is there a link between viral infection, microbiome, and medical complications during hospitalisation in neonatology ? Participants will have a nasal swab taken each week during their hospitalisation in neonatology, and researchers will take medical data from the medical chart.

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.