11 Clinical Trials for Various Conditions
The purpose of this study is to compare the additional use of gloves (with handwashing before and after gloving) for all patient contact while infants have intravenous (central or peripheral) access in a RCT. Preterm infants \<1000 grams or less than 29 weeks gestational age will be randomized after birth to either a handwashing-gloving group or handwashing only group. The primary outcome will be the incidence of invasive infections (bacterial or fungal) or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm morbidities, mortality, and hospital costs.
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free survival at 18-22 months corrected age.
This is a prospective in vitro cell biology study of polymorphonuclear leukocyte (PMN) protein synthesis in response to PAF. PMNs from cord blood of premature human infants at risk for NEC (birth weight between 501 - 1500 grams) and PMNs from cord blood of healthy term infants will be isolated and stimulated with PAF, a biologically active phospholipid implicated in the pathogenesis of NEC. NEC, a disease of prematurity with an incidence of 10.1% of infants born weighing between 501 - 1500 grams, is associated with significant morbidity and mortality. We will compare the protein synthesis of inflammatory modulators, including Interleukin 6 Receptor alpha (IL-6R alpha) and Retinoic Acid Receptor alpha (RAR alpha) proteins to protein synthesis responses already observed in PMNs isolated from healthy adults. Furthermore, we will characterize the expression and activity of the mammalian target of rapamycin (mTOR) translational protein synthesis control pathway in PMNs isolated from preterm and term infants and compare those results with previous observations in PMNs isolated from adults. This pathway is known to regulate IL-6R alpha and RAR alpha protein expression in PMNs isolated from adults. We will also follow those premature infants at risk for NEC clinically to determine which infants develop NEC and what risk factors may be associated with NEC in this population.
OBJECTIVES: I. Compare the incidence of late onset sepsis and/or necrotizing enterocolitis and duration of hospitalization in low birth weight infants fed with fortified mother's milk supplemented with either fortified pasteurized donor human milk or preterm formula, and with fortified mother's milk versus preterm formula. II. Determine the relationship between functional antibody titers in serial milk samples and the incidence of pathogen specific late onset sepsis (e.g., Staphylococcus epidermidis, Staphylococcus aureus) in these patients. III. Determine the long term sequelae (growth, body composition, health, and neurodevelopment) of human milk versus formula feeding in these patients. IV. Determine the relationship between stress and milk production in the mothers of these patients.
This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.
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.
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
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.
Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function. In early PN-associated cholestasis, the dose of traditional soy based lipid is limited to 1 g/kg/day which often limits the growth capacity of parenteral nutrition-dependent infants. Inadequate growth is directly related to poor neurological outcomes, failure to facilitate mechanical ventilation, and less growth of the neonate's already damaged intestine. Ultimately, these outcomes can lead to severe disability and death. To mitigate these deleterious effects and optimize growth, parenteral nutrition-dependent infants with cholestasis who are not adequately growing on 1 g/kg/day of soy-based lipid emulsion must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth. SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids. The utility of Omegaven and soy-based lipid emulsion is limited as these are restricted to 1 g/kg/day in cholestatic infants. SMOFlipid is safe to be provided at the usual goal infusion amount of 3 g/kg/day. Because this product includes both omega-6 and omega-3 lipids, it provides the benefits of the omega-3s for the liver and provides more than enough omega-6s to meet essential fatty acid requirements. Its use in situations in which growth is inadequate in babies who must be restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase their chances of both a good neurological outcome and survival. The aim of this research study is to determine if the unique formulation of SMOFLipid will cause less hepatic inflammation compared to soy only intralipids.
The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP preoperatively and the importance of this distinction on outcome measures; and 3) to evaluate the association between extent of intestinal disease determined at operation and outcome measures. All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.