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Enterocolitis clinical trials

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NCT ID: NCT00787124 Completed - Anemia Clinical Trials

Transfusions and Nitric Oxide Level in Preterm Infants

Start date: September 2008
Phase:
Study type: Observational

The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused blood of extremely preterm infants. The long term goal of the project is to identify variation in the SNO-Hb between packed red blood cell units, and between and among individual preterm infants pre and post-transfusion. Duke investigators are developing methods to replenish SNO-Hb, which, if successful, would improve RBC deformation in addition to providing a vasodilatory stimulation to hypoxic tissue, and lead to a randomized clinical trial testing treated vs. untreated RBC transfusions in extremely premature infants. AIM 1. Measure the Total Hemoglobin (Hb)-bound nitric oxide (NO), Hb [Fe] NO, SNO-Hb (a calculated value = (total Hb-NO - Hb [Fe] NO) in blood to be transfused in extremely preterm babies, and in samples pre and post- transfusion from the babies. Hypothesis 1: Measures of NO and SNO-Hb will be low in blood used for transfusion in preterm infants and will be decreased in the post-transfusion samples from the infants compared with the pre-transfusion samples. AIM 2. Collect clinical data about study participants, including oxygen saturation and measures of perfusion pre and post-transfusion. Hypothesis 2: Measures of perfusion will be reduced by 20% post-transfusion in extremely preterm infants.

NCT ID: NCT00707785 Completed - Sepsis Clinical Trials

Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether vitamin A can improve survival and facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates.

NCT ID: NCT00630838 Completed - Clinical trials for Hirschsprung Disease

Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)

Start date: September 2006
Phase: Phase 2
Study type: Interventional

Prospective, randomized, controlled trial to test if post-operative administration of probiotics in HD patients will lead to a reduction in the occurrence of HAEC.

NCT ID: NCT00621192 Completed - Clinical trials for Necrotizing Enterocolitis

Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections

Start date: June 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known. The purpose of this study is to determine the correct dose and the safety of meropenem for the treatment of complicated intra-abdominal infections in these young babies.

NCT ID: NCT00616876 Completed - Sepsis Clinical Trials

Lactulose Supplementation in Premature Infants

Start date: February 2005
Phase: Phase 2
Study type: Interventional

A pilot study to test the safety of use of lactulose in preterm infants and to preliminary assess the hypothesis that lactulose would support the early growth of Lactobacilli in the stools of premature infants and possibly would also improve nutritional status and decrease NEC and late-onset sepsis.

NCT ID: NCT00463190 Completed - Diarrhea Clinical Trials

Effect of Probiotics (Bio-Three) in Children's Enterocolitis

Start date: February 2006
Phase: Phase 4
Study type: Interventional

Probiotic bacteria inhabit the gastrointestinal tracts of healthy individuals and may improve the health status of patients with digestive disease. The first aim of our study will seek to determine if probiotics medication (Bio-Three) inhibit gastrointestinal infection and reduce its inflammatory response in the intestine. The second aim will explore the bacterial count (microbiology) and subsequent immune response in probiotic inhibition of enterocolitis in children. We try to seek to gain an advanced understanding of probiotics versus pathogenic microorganism and host interactions, and mucosal immune responses to probiotics in the intestine.

NCT ID: NCT00392977 Completed - Clinical trials for Necrotizing Enterocolitis

Brain Manganese Deposition in High Risk Neonates

Start date: August 2006
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00392730 Completed - Clinical trials for Necrotizing Enterocolitis

Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children

Start date: August 2006
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00332592 Completed - Clinical trials for Necrotizing Enterocolitis

Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (NEC)

Start date: October 2006
Phase: Phase 4
Study type: Observational

NEC is a serious inflammatory bowel disease, which almost only strikes infants with low birth weight and low gestational age. The morbidity and mortality rates are high, and early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of intragastric microdialysis and whether it is able to select patients, who may benefit from either medical or surgical therapy. The aim of intraperitoneal microdialysis is to evaluate whether changes in intraperitoneal microdialysis reflect the clinical outcome after laparotomy.

NCT ID: NCT00315263 Completed - Respiratory Failure Clinical Trials

Genomics, Single Nucleotide Polymorphisms (SNPs), and Clinical Neonatology

Start date: April 2006
Phase: N/A
Study type: Observational

This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain Injury (PVI), Necrotizing Enterocolitis (NEC), or Hypoxic Respiratory Failure (HRF).