Clinical Research Directory

A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women

The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like protein 2 and 3 (Alp2-3N), after a primary vaccination with GBS-NN/NN2 in all participants.

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.

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

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.

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.

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

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.

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.

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

COPE - COVID-19 in Pregnancy and Early Childhood

Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in the human race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both for individual human lives as well as for the society and the health care sector. The knowledge on how this new infection affects both the mother and the unborn child as well as the outcomes for the mother and the child in the long run are unknown. What is known is based on case-reports and small case-series solely. Both the coronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring, which leads to the question whether this could be the case also for SARS-CoV-2. Aims: To establish a biobank of biological material from infected as well as non-infected pregnant women and their offspring. To combine this biobank with Swedish quality and health care registers, computerized patient charts and questionnaire data, enabling both short-term follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and child. To study how the pandemic situation affects both the mother and her partner in their experience of pregnancy, childbirth, and early parenthood. Design: A national Swedish multicentre study. Women are included when they have a positive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included at their routine visits (Screening group). Blood samples and other biological material will be collected at different time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy Register as well as obligatory Swedish health registers. The biobank and its linkage to health registers through the Swedish personal identification number will enable future research. Child development will be followed during the first year of life by questionnaires to the parents. Womens' and their partners' experience of childbirth and parenthood will be studied in form of questionnaires as well as in form of interviews. Conclusion: This project will help obstetricians and neonatologists better recognize clinical manifestations of the virus, identify possible risk factors during pregnancy and tailor therapies alongside providing right level of surveillance and management during pregnancy, delivery, and child health care.

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.

National Bacterial Meningitis Study

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.