Neonatal Infection

9

Review clinical trials related to Neonatal Infection. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection

This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.

Participants needed: 630
Trial details
Age: 0-28Biological sex: AllType: ObservationalSponsor: Rigshospitalet, DenmarkUpdated: Jun 9, 2026Locations: 2
Eligibility criteria

Children born between 1 January 2010 and 31 December 2025 with an available neon... [+2]

DBS samples not approved for research use. [+2]

Status: Recruiting

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

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.

Participants needed: 175
Trial details
Phase: Phase 1Age: 0-60Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Jun 8, 2026Locations: 1
Eligibility criteria

Neonate has anticipated NICU length of stay > 7 days [+3]

Neonate has had a prior clinical or surveillance culture grow S. aureus [+12]

Status: Recruiting

National Bacterial Meningitis Study in Children and Newborns

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.

Participants needed: 10,000
Trial details
Age: 1-18Biological sex: AllType: ObservationalSponsor: Association Clinique Thérapeutique Infantile du val de MarneUpdated: Apr 28, 2026Locations: 1
Eligibility criteria

clinical signs of meningitis, associated with positive cerebrospinal fluid (CSF)... [+1]

Status: Recruiting

Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

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.

Participants needed: 3,250
Trial details
Phase: Phase 3Age: 0-59Biological sex: AllType: InterventionalSponsor: Harvard School of Public Health (HSPH)Updated: Dec 12, 2025Locations: 1
Eligibility criteria

Young infants aged 0-59 days [+4]

Prior use of zinc supplements during the current illness [+5]

Status: Recruiting

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

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

Participants needed: 80
Trial details
Age: Up to 6Biological sex: AllType: ObservationalSponsor: Medical University of GrazUpdated: Mar 13, 2025Locations: 1
Eligibility criteria

Signs of respiratory distress at time-point of inclusion (tachypnoea >60/minutes... [+3]

No decision to conduct full life support [+4]

Status: Recruiting

Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections

The management of premature infants hospitalized in neonatal units requires the simultaneous intravenous (IV) infusion of several drugs and parenteral nutrition solutions, when oral administration is impossible or unsuitable. IV administration requires the use of a central venous catheter and an infusion set that connects the catheter to the infusion fluid or drug. The use of multiple infusion devices exposes patients to central line-associated bloodstream infections (CLABSI), drug interactions, abnormal administration timing and repetition of procedures in close proximity to the infant. Against this backdrop, DORAN INTERNATIONAL has developed the EDELVAISS multi-infusion strategy (Multiline Neo® and Escape Line® devices) adapted to neonatology. Given its characteristics, the benefits expected from the use of this strategy are: 1) to reduce the risk of microbial contamination and therefore the number of nosocomial infections 2) reduce exposure to antibiotics used in late sepsis 3) reduce the number of central line losses due to catheter obstruction 4) reduce dys-stimulating procedures in contact with the infant and 5) reduce staff stress. A pilot study before (year 2019) and after (year 2020) was carried out in the tertiary care neonatal unit at Croix-Rousse hospital. The baseline CLABSI rate was slightly below the national level of the last French survey (12.4/1000 catheter days \[95%CI:10.8;14.0\]). In 322 very-low-birth-weight infants, the investigators showed a significant 88% reduction in the rate of catheter-related bacteremia, from 11.3 to 2.2 infections per 1,000 catheter-days after implementation of the EDELVAISS multi-infusion strategy. Since this pilot study, the EDELVAISS multi-infusion strategy has been used routinely in the neonatology department for around 2,000 infants admitted to the neonatology department at Croix-Rousse hospital. The low CLABSI rate observed in 2020 was maintained over the following 2 years. Several tertiary care neonatology departments have implemented the EDELVAISS multi-infusion strategy (ten departments have already done so, and five are in the process of doing so). The three neonatal units that agreed to take part in the EDELVAISS study also wish to implement the EDELVAISS multi-infusion strategy. The invetsigators hypothesize that the reduction in CLABSI rates observed in the neonatal unit at Croix-Rousse hospital during the pilot study will be found in other French neonatal units, whatever the initial practices and devices used in each center.

Participants needed: 455
Trial details
Age: Up to 32Biological sex: AllType: ObservationalSponsor: Hospices Civils de LyonUpdated: Jan 22, 2025Locations: 3
Eligibility criteria

Gestational age at birth ≤ 32 weeks [+6]

Opposition by parents or guardians [+3]

Status: Recruiting

Exploring Vancomycin Disposition in Neonates

Vancomycin is already used for decades in neonates. However, there are remaining questions concerning vancomycin disposition in this population. The purpose of this study is first of all to perform a paired analysis of serum vancomycin concentrations using an immunoassay versus a reference liquid chromatography-tandem mass spectrometry method. Secondly, we aim to determine vancomycin protein binding and its covariates in neonates.

Participants needed: 120
Trial details
Phase: Phase 4Age: 1-23Biological sex: AllType: InterventionalSponsor: Universitaire Ziekenhuizen KU LeuvenUpdated: Jul 12, 2024Locations: 1
Eligibility criteria

Neonates, admitted to the Neonatal Intensive Care Unit to whom vancomycin is adm...

No vancomycin therapy [+1]

Status: Recruiting

Prenatal Antibiotics and Breast Milk / Neonatal IgA

In this biological study, the investigators 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

Participants needed: 82
Trial details
Age: 18-40Biological sex: FemaleType: ObservationalSponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUpdated: Jun 26, 2024Locations: 1
Eligibility criteria

expression of written informed consent [+2]

absence of written informed consent [+5]

Status: Recruiting

Neonatal Infection Surveillance Database

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.

Participants needed: 12,000
Trial details
Age: 1-12Biological sex: AllType: ObservationalSponsor: St George's, University of LondonUpdated: Feb 24, 2023Locations: 1Duration: 28 Days
Eligibility criteria

Infants on participating Neonatal Units who have an episode of infection with a...