Active clinical trials for "Enterocolitis, Necrotizing"

Antenatal absent or reversed end-diastolic flow (AREDF) velocity through the umbilical arteries places preterm infants at significant risk for developing gastrointestinal complications, such as feeding intolerance, necrotizing enterocolitis or spontaneous intestinal perforation. Due to the fear of the aforementioned conditions, the establishment of adequate enteral feeds is frequently hampered in this population. Previous postnatal Doppler studies have shown that AREDF preterm infants who later developed feeding intolerance have a decreased blood flow velocity in the superior mesenteric artery in response to the first enteral feed; to date, however, it is not known whether this hemodynamic impairment persists over time, or if it is associated with reduced splanchnic oxygenation and perfusion, monitored by Near-infrared spectroscopy (NIRS). This observational prospective study aims: to assess the patterns of abdominal oxygenation and perfusion in response to enteral feeds in AREDF preterm infants at different phases of enteral feeding establishment; to evaluate a possible correlation with the development of gastrointestinal complications.

Necrotizing enterocolitis (NEC) affects up to 10% of very preterm infants. NEC mortality is high (30-50 %) and has remained unchanged over the last decades. New treatments are urgently needed. NEC pathogenesis is multifactorial, but bowel ischemia plays an essential role in NEC development. Remote ischemic conditioning (RIC) consists in inducing brief periods of non-lethal ischemia in a limb distant to an organ suffering from ischemia. RIC has been used in adults, children and term neonates with a variety of diagnosis. However, no study has been done including preterm infants with NEC.

Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns. During the last years, investigators ran retrospective observational studies abut NEC developing within the 48 hours after red blood cell transfusion. In the previous studies, the incidence of transfusion associated NEC (TANEC) was found to be 20-35%.Multiple transfusions potentially cause an increased risk for retinopathy of prematurity (ROP) and NEC. Investigators have also proposed a hypothesis about transfusion related acute gut injury (TRAGI), an adverse reaction of transfusion, similar to transfusion related acute lung injury (TRALI) seen in adults.In most of the neonatology clinics, withholding feeds during transfusion is not preferred. But several recent studies show an increase in the incidence of TANEC if the newborn goes on feeding before, during and after the transfusion process, especially if it is fed with a formula. The main aim of this study is to investigate the effect of withholding feeds during transfusion, on the development of TRAGI.

Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased risk of Mn neurotoxicity because neonatal PN solutions contain high concentrations of Mn. This proposal will investigate brain deposition of Mn, a paramagnetic element, by magnetic resonance (MR) imaging in preterm and term neonates receiving Mn-supplemented PN and gestational age-matched control infants. The goals of this project are to identify neonatal populations that are at increased risk of excessive brain Mn deposition based on their gestational age, iron status, hepatic function and dietary Mn intake, and to make evidence-based recommendations for appropriate Mn supplementation and monitoring of infants receiving PN.

Prophylactic probiotics have been shown to decrease the incidence of Necrotizing Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live bacteria to small babies. Based on animal data, the investigators hypothesized that heat inactivated probiotics would also reduce NEC.

Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding intolerance (FI) or necrotizing enterocolitis (NEC), which is the most feared gastrointestinal complication of prematurity. The occurrence of FI often prompts clinicians to withhold, decrease or discontinue enteral feeds; thus, the establishment of an adequate early enteral nutrition is frequently hampered. Early identification of preterm infants at high risk for gastrointestinal complications could help clinical decisions on the introduction and the advancement of enteral feeding. Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen saturation (rSO2). A significant correlation between lower abdominal rSO2 values in the first week of life and subsequent NEC development has been reported. To date, however, splanchnic oxygenation patterns in response to the first bolus feed and possible correlations with subsequent FI development have not been yet established. This observational prospective study aims: to assess abdominal rSO2 patterns in response to the first bolus feed; to evaluate possible correlations with subsequent development of gastrointestinal complications.

Bacterial infections are a major cause of death in newborn infants. And are linked to complications including: sepsis (an over exaggerated immune response to infection) and necrotising enterocolitis (a potentially fatal inflammatory bowel disease). Detecting infections at an early stage is difficult in newborns as the signs and symptoms can be non-specific, the most commonly used lab test is to culture a sample of blood, urine or spinal fluid to try and grow and identify any bacteria that is present; however these tests take 24-48 hours to give results, and this means that neonates who present with signs of infection are prescribed broad spectrum antibiotics whilst results are obtained. The lack of a test that can detect infection at an early stage and give rapid results is one of the major problems in the diagnosis and management of infection in newborns. This study will investigate neutrophils, which are white blood cells that are important in fighting infection. When neutrophils detect and infection they become activated, and produce a protein called CD64 (a cell marker) on their surface, and it is this protein that we want to measure. Neutrophils produce the CD64 protein within 1 hour of first detecting an infection, so we could hopefully detect and treat infections much quicker. The hypothesis this study will test are: Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker of infection in neonates AND: Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker of NEC in neonates

Manganese (Mn) is an essential metal required for normal growth and development. However, exposure to high Mn levels can be toxic to the brain. The objectives of this project are to identify neonatal and young pediatric populations that are at increased risk of excessive brain Mn deposition and altered cognitive and motor development based on their dietary parenteral Mn exposure, and to make sound and evidence-based recommendations for appropriate Mn supplementation and monitoring of infants and young children receiving parenteral nutrition (PN). Our studies are designed to test the hypotheses that, compared with unexposed age-matched controls, infants and young children receiving prolonged Mn-supplemented PN will have increased deposition of Mn in their brains and lower scores on neurodevelopmental, cognitive and psychophysiological assessments.

The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.

The purpose of this study is to evaluate the effect of probiotic administration on TPN dependence in infants < 32 weeks GA and BW 1500 grams or less in the Banner - University Medical Center Phoenix and Banner Children's at Desert Neonatal Intensive Care Units (NICU). The primary endpoint of capturing the number of days of TPN administration can reflect that an infant is progressing towards readiness for the initiation or advancement of enteral feedings at an earlier interval. The relationship between probiotic administration and the incidence of NEC, culture positive sepsis, and mortality is of interest to us and will be captured. Finally, the assessment of the tolerance of probiotic administration and the potential positive impact on growth and development in these premature infants may validate our current practices.