Clinical Research Directory

Neonatal Catheter Lock for Infection Prevention

For newborns admitted to Neonatal Intensive Care Units (NICUs), one of the main risk factors for late-onset sepsis is the presence of a central venous catheter (CVC), which is often essential for the administration of medications and parenteral nutrition in this patient population. From a nosological perspective, sepsis associated with the presence of a venous catheter is defined by two acronyms: CRBSI (Catheter-Related Bloodstream Infection - a microbiological definition) and CLABSI (Central Line-Associated Bloodstream Infection - an epidemiological definition). Among preventive strategies for CRBSI/CLABSI, antibiotic or antimicrobial catheter lock solutions - instilled in a volume equivalent to the catheter dead space and retained within the lumen until the next use - have demonstrated favorable efficacy in reducing infection risk. Taurolidine 2% is considered a preferred agent due to its broad-spectrum antibacterial and antifungal activity and its lack of association with the development of antimicrobial resistance. However, its prophylactic use in neonates remains largely investigational, with current evidence limited to small, retrospective observational studies involving catheters ≥3 Fr (e.g., femoral inserted central catheters - FICCs, centrally inserted central catheters - CICCs, and umbilical venous catheters). In NICUs, epicutaneo-caval catheters (ECCs) are the most commonly used central venous access devices and represent a major source of catheter-related infections. Despite this, the use of antimicrobial lock prophylaxis in ECCs has been limited by concerns regarding catheter occlusion, given their smaller diameter (≤2 Fr). Nevertheless, available evidence indicates that short-duration locks, when combined with meticulous infusion line management, can be safely implemented without increasing the risk of catheter occlusion. The aim of the study is to evaluate the efficacy of 2% taurolidine lock in the prevention of CLABSI/CRBSI in neonates with CVC (ECC, FICC, or CICC).

Vancomycin Reduction Practices (VRP) in the NICU

This multi-center, cluster randomized study aimed at improving implementation of vancomycin reducing practices (VRP) in neonatal intensive care units (NICUs). Sites will be recruited and randomized to receive either external facilitation or no external facilitation to assess the effect on center-level fidelity to the core components of VRP implementation. Interventions available to both study arms are directed at hospital staff and includes identification of local champions, educational outreach, unit-level audit \& feedback, and use of a clinical decision support tool.

Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial

The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g. The main questions it aims to answer are: * Does the early use of hydrocortisone help solve shock in preterm infants under 1500 g faster than the standard treatment? * Does the early use of hydrocortisone help prevent death within the first seven days of presentation of shock in comparison to premature infants who receive regular treatment? Researchers will compare the early use of hydrocortisone plus the standard treatment to solve shock against just standard treatment. Participants will: * Be randomized to receive standard treatment for shock according to their neonatologist or this standard treatment plus hydrocortisone as soon as the diagnosis is done and treatment is started. * Be followed either until shock is solved or if they present death due to this event of shock.

Amniotic Fluid & the Preterm Gut

Background: Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations. An important yet understudied contributor in the development of the gastrointestinal tract (GIT) is amniotic fluid (AF). Knowledge is lacking on the critical shifts that may occur in AF in extremely preterm birth. The aim of the current study is to assess the composition of AF using advanced biomedical techniques. Secondary objectives are to assess AF profiles of infants with chorioamnionitis (CAM) and/or fetal growth restriction (FGR), assess key metabolites across gestation, correlate AF profiles with neonatal outcomes, and explore associations with early gut microbiota. Methods: ln this multicenter, prospective, cohort study, AF (\~5 mL) will be collected from obstetric patients delivering their infants extremely preterm (gestational age (GA) 24+0/7-27+6/7 weeks, n=125), either during vaginal delivery or cesarean section (CS). Additionally, AF samples will be collected from a reference group (n=150), including early midtrimester (GA \<23+/7 weeks), very early and moderate to late preterm (GA 28+0/6-36+6/7 weeks), and full-term pregnancies (GA 37+0/7-41+6/7 weeks). Thorough characterization of AF will be conducted, including microbial profiling and metabolomics. Microbiota profiling of neonatal fecal samples will be conducted to assess the association between AF and early neonatal gut colonization patterns. Discussion and expected results: AF profiles associated with CAM and/or FGR in extremely preterm infants are expected to be identified, as well as relevant associations with neonatal health outcomes (including NEC and sepsis) and early neonatal gut colonization patterns. The current study will not only increase the understanding of the GIT development and the pathogenesis of NEC and sepsis but may also aid in the identification of high-risk infants. In the future, these findings may facilitate early targeted microbiota-based interventions to prevent disease progression and ultimately improve clinical outcomes.