View clinical trials related to Enterocolitis.
Filter by:Our study aims to determine the differences in the concentration of urinary claudin-2, caveolin-1, and epidermal growth factor (EGF) as non-invasive biomarkers in the diagnosis of Necrotizing Enterocolitis (NEC). We compare the concentration of urinary claudin-2, caveolin-1, and EGF between preterm neonates at risk of NEC and healthy term infants as the basis for determining NEC biomarkers with the most optimum sensitivity and specificity. This analytical observational study is based on biomolecular profiling with a prospective cohort design approach. The research subjects are a group of preterm neonates (gestational age of 28-34 weeks) who were admitted in Perinatology Unit, Department of Pediatrics, Saiful Anwar General Hospital, Malang and whom diagnosed with NEC using Bell's criteria and serum TGF-β levels. Subjects are selected by consecutive sampling and single-blind analysis was performed in the Laboratory of Bioscience and Biomedicine, Faculty of Medicine, University of Brawijaya. During the research process, groups of preterm and term neonates would be observed and their clinical development followed. The collection of biologic samples would be taking 10 cc of urine and 40 mg of feces on day-5 (D5) and 7 (D7). The consecutive manner of urinary sampling was regarded to assess whether there was a time-related protein expression in the course of the NEC process. Faecal samples would be assessed for microbiota profile analysis described by the ratio of Proteobacteria: Firmicutes and Bacteroidetes to represent dysbiosis process in NEC. After 7 days, the subjects would be grouped into a group of preterm neonates with NEC, a group of healthy term neonates as a control, while a group of preterm infants at whom during the course of the study did not develop NEC, would be assigned to group of premature neonates without NEC. Urinary protein concentrations from the three groups would then be analyzed and adjusted with normalized creatinine, so that the levels of these three proteins could be assessed quantitatively using the ELISA (Enzyme-Linked Immunosorbent Assay) method. The results would be compared with the microbiota profile as the golden standard for NEC cases. Through statistical tests, sensitivity, specificity and cut-off of selected protein levels would be assessed as diagnostic biomarkers of NEC.
This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants. Inclusion criteria were infants with a gestational age of 25-31 weeks 6 days who experienced respiratory distress and their families had agreed to participate in the study, then randomized. The intervention was in the form of giving azithromycin in the intervention group and no intervention was carried out in the control group and then followed up to 36 weeks PMA
Necrotizing enterocolitis (NEC) is a serious intestinal disease of preterm and term neonates which remains a major cause of intestinal failure, and an unsolved clinical challenge in pediatrics. While overall mortality of preterm infants continues to decrease due to improvements in general neonatal care, mortality caused by NEC remains high (up to 30-50%) and survivors suffer from reduced quality of life, and long-term disabilities such as debilitating complications of intestinal failure, poor growth and neurodevelopmental delay. Besides prevention, there have been hardly any innovations in the treatment of NEC which underwent trial evaluation. NEC pathogenesis is multifactorial, but bowel ischemia is known to play an essential role in the development of NEC. Remote ischemic conditioning (RIC) is a therapeutic maneuver that involves brief cycles of non-lethal ischemia and reperfusion applied to a limb, which protects distant organs (such as the intestine) from ischemic damage. The investigators have shown that in preclinical models of NEC, RIC effectively reduces intestinal damage and prolongs survival. The investigators have also demonstrated the safety of RIC in preterm neonates with NEC. Before the investigators can evaluate the effectiveness of RIC in treating neonates with NEC in a Phase III randomized clinical trial (RCT), a Phase II Feasibility RCT must be conducted to evaluate issues related to the enrollment and randomization of neonates, masking of the RIC intervention, and measurement of clinical outcomes. The investigators hypothesize that it is feasible to conduct a multicenter RCT to evaluate RIC during the management of neonates with medical NEC.
PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants This pilot triol has the primary goal of demonstrating the safety of transferring viruses and proteins from healthy term infants to preterm infants born between gestational age (GA) 26 + 0 and 30+6. The long-term goal is to develop a safe and effective treatment to prevent the severe gut disease called necrotizing enterocolitis (NEC). NEC is a common disease in neonatal intensive care units affecting 5-10% of all admitted patients. 15-30% of the affected children die from the disease, and many of the survivors suffer from the effects of extensive gut surgery. While the disease is caused by many different factors, recent research has shown the gut microbiome to be a central factor in the development of NEC. Furthermore, in the recent years special viruses called bacteriophages have shown potential in the treatment of various diseases. By collecting feces from healthy, term infants and filtering it thoroughly, the investigators can provide a treatment that contains practically only viruses, proteins and nutrients. It is our belief that giving the preterm infants a mix of viruses including bacteriophages will prevent NEC. To do this, the investigators will go through 3 stages: 1. Recruiting and following healthy donor infants to study the microbiota and use feces from them to donate in stage 2 and 3 2. Examining the safety of the treatment as well as how it works in preterm piglets STAGE 3 will be performed only if stage 2 shows no serious risks for the infants 3. Testing the treatment in preterm infants. 10 preterm infants will receive the treatment and 10 preterm infants will receive placebo. The investigators expect to see no serious side effects to the treatment. The investigators hope, but do not expect to be able to see a beneficial effect of the treatment. If this pilot trial shows promising results, it will be followed be a larger clinical trial.
Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW) infants. Multi-nutrient human milk fortifiers (HMFs) are designed to meet the macro and micro-nutrient needs of VLBW infants. HMFs differ by the origin of milk and by nutrient composition. Traditionally, bovine milk has been the main source of multi-nutrient HMFs.
The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (<30 weeks) will reduce the occurrence of Necrotizing Enterocolitis (NEC). Currently both continued feeding and withholding feeding are approved care practices. The current study will randomize infants from Neonatal Intensive Care Units (NICUs) across Canada and the United Kingdom (UK) into one of the two care approaches (withholding or continued feeds) to determine if any significant outcomes are found.
Pre-clinical animal studies provide robust evidence regarding the beneficial effect of stem cells for intestinal disease. This single-center, randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing NEC in preterm neonates,and influence on growth and development.
Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality. Early diagnosis and early treatment interventions may reduce the risk of mortality and morbidity. The Primary goal of this observational study is to gather survey data to establish a national database of NEC in newborns in order to better understand the risk factors underlying NEC. Survey data will be used along with a medical history to identify the mechanism(s) underlying the increased prevalence of NEC in non-breast fed, formula fed premature infants.
This is a multicenter randomised controlled trial to assess whether standardised enteral feeding in newborns with duct dependenty congenital heart disease decreases the risk of necrotising enterocolitis (NEC). The investigators plan to include a total 384 infants. The study will be carried out in three level III hospitals in Poland. The primary end will be NEC and/or death. Secondary end points include weight gain, hospital length of stay, time required to reach full feeding.
The objective of this trial is to investigate whether a treatment strategy offering bezlotoxumab before FMT in patients suffering from multiple recurrent CDI results in equal efficacy compared with a treatment strategy with initial FMT. Strategy A includes bezlotoxumab as ancillary treatment as first option, and FMT in case of failure. Option B includes FMT as ancillary treatment as first option, and antibiotic treatment with fidaxomicin in case of failure. A secondary objective is to provide a point estimate of recurrence after bezlotoxumab for the treatment of multiple recurrent CDI.