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Necrotizing Enterocolitis clinical trials

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NCT ID: NCT00588718 Active, not recruiting - Clinical trials for Necrotizing Enterocolitis

A Biologic Validation of Biomarkers of Progressive NEC & Sepsis

NEC
Start date: April 2007
Phase: N/A
Study type: Observational

Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies. If it progresses, the wall of the intestine may perforate, spilling bacteria and stool into the abdomen. Parts or all of the intestine may die. Despite 30 years of clinical studies, the cause of NEC remains unknown. In this study, we will be conducting an independent case-control validation study to verify the diagnostic and prognostic biomarker panels, develop validated biomarkers on boisensors in preparation for prospective validation studies, and conduct independent prospective validation of biosensor based biomarker panels on clinical samples.

NCT ID: NCT00437567 Recruiting - Clinical trials for Necrotizing Enterocolitis

Prebiotics in the Prevention of Necrotizing Enterocolitis

Start date: July 2009
Phase: Phase 2
Study type: Interventional

Necrotizing enterocolitis (NEC) is the most common gastrointestinal catastrophe affecting 10-15% of premature neonates of <1500 gm. NEC is a disease of the immature intestine, characterized by impaired mucosal barrier function leading to increased gut permeability. We have previously demonstrated a protective effect of probiotic administration against the development of NEC. Others have shown that prebiotics can stimulate natural production of bifidobacteria and lactobacillus in the preterm gut. We have therefore hypothesized that prophylactic administration of prebiotics would also provide protection against necrotizing enterocolitis in the premature neonate, without the potential for sepsis which has been reported on rare occasions with probiotics administration.

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).

NCT ID: NCT00271336 Recruiting - Clinical trials for Necrotizing Enterocolitis

Pentoxifylline in the Treatment of NEC in Premature Neonates

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

Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature neonates.

NCT ID: NCT00254176 Unknown status - Sepsis Clinical Trials

Cysteine Supplementation in Critically Ill Neonates

Start date: September 2006
Phase: Phase 2/Phase 3
Study type: Interventional

Critically ill babies less than 1 month of age have deficient amounts of the antioxidant glutathione and a high incidence of disease associated with oxidative injury compared to healthy babies. These diseases include but are not limited to damage to the eyes, lungs, and intestines. Frequently becoming chronic and potentially life threatening, these diseases result in a significantly decreased quality of life to the infant along with increased costs to the infant's family and society. The amino acid cysteine comprises a third of the tripeptide glutathione and directly influences glutathione production. Older children ill with infection and stable, premature neonates administered cysteine supplementation to their diet have been previously shown to increase their glutathione production and concentrations. Furthermore, cysteine supplementation in the ill children resulted in a quicker resolution of their illness. Although most critically ill babies require IV nutrition (i.e., TPN) before and during their illness, commercially available TPN does not include cysteine as a significant nutrient. Cysteine has effectively become a safe and standard supplement to routine TPN in a few major hospitals in the U.S. The purpose of this study is to evaluate the ability of cysteine supplementation to increase glutathione production and concentrations in critically ill babies. Furthermore, the investigators want to evaluate whether cysteine supplementation results in less oxidative tissue injury and ultimately less severe illnesses. The study will enroll babies admitted to the UCLA Medical Center Neonatal Intensive Care Unit (NICU) and they will be chosen at random and in a blinded fashion to receive either cysteine or non-cysteine supplementation to their routine TPN. Small blood samples along with a single 6 hour infusion of a non-radioactive, stable isotope labeled amino acid will be used to measure the production of glutathione as well as other compounds in the blood to give a quantitative assessment to the severity of illness. Clinical information relevant to the babies' illness and subsequent recovery will be recorded. The results will be compared between cysteine vs. non-cysteine groups and before vs. after individual supplementation. By demonstrating the effect of cysteine supplementation on glutathione production, the incidence and/or severity of disease from oxidative injury in critically ill babies may be decreased if glutathione production is improved.

NCT ID: NCT00252681 Completed - Clinical trials for Necrotizing Enterocolitis

Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

Start date: July 1999
Phase: N/A
Study type: Interventional

The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.

NCT ID: NCT00120159 Active, not recruiting - Clinical trials for Necrotizing Enterocolitis

Necrotizing Enterocolitis (NEC) Surgical Database

Start date: December 2003
Phase: N/A
Study type: Observational

The general objectives of this protocol are to develop a multi-center prospective data collection process to identify risk factors for progression of Necrotizing Enterocolitis (NEC). These data will be used as a basis for identifying management strategies appropriate for further evaluation (randomized controlled trials), to develop evidence-based standards of care, and as a tool to facilitate quality-assessment at individual centers through comparison of outcomes with the entire database.