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Enterocolitis, Necrotizing clinical trials

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NCT ID: NCT01674478 Completed - Prematurity Clinical Trials

Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies

EMLFO-2
Start date: October 2012
Phase: Phase 2
Study type: Interventional

Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common devastating gastrointestinal diseases in premature infants. These infants often need surgical intervention to remove the dead bowel and create temporary enterostomies, resulting in short bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or dysfunction to digest and absorb nutrients adequately. These infants are often nourished primarily with parental nutrition (PN) which can lead to many complications including PN-associated liver disease. However, with enteral feeding, the remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty acids (LCPUFA) being the most beneficial in promoting bowel adaptation. Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation. Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and increase weight gain in some SBS infants. WThe investigators will soon have completed a randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled "Early Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with Enterostomies". The preliminary data suggest that (a) by supplementing enteral ML/FO, we were able to decrease the use of IL; (b) premature infants in the treatment group who received ML/FO achieved higher enteral calorie (% of total calorie) intake before reanastomosis and better weight gain (g/day) after reanastomosis than those who received routine care in control group; and (c) the direct bilirubin level before reanastomosis tended to be lower in the treatment group than the control group although the difference was not statistically significant. Because the intervention consisted of both an increase in enteral fat intake as well as a specific type of fat intake (i.e. FO), it is unclear whether improved outcomes in the ML/FO group are attributable to FO's anti-inflammatory effects or the increased fat intake. Therefore, the investigators have designed a next randomized clinical trial to compare ML alone versus ML plus FO. We hypothesize that as compared to ML alone, ML plus FO will result in decreased systemic inflammation, as indicated by blood levels of inflammation-related proteins and indicators of oxidative stress.

NCT ID: NCT01670916 Completed - Clinical trials for Necrotizing Enterocolitis

Probiotics to Prevent NEC - a Historical Control Study

Start date: March 2010
Phase: Phase 4
Study type: Observational

Probiotics is given routinely to infants admitted to the department of neonatology during the first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1 March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009 will be compared.

NCT ID: NCT01603368 Completed - Sepsis Clinical Trials

Prophylactic Probiotics to Extremely Low Birth Weight Prematures

PROPEL
Start date: June 2012
Phase: Phase 2
Study type: Interventional

Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common problem resulting in prolonged need for intravenous lines and poor nutrition. The aim of the study is to evaluate whether supplementation with the probiotic bacterium Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight increases feeding tolerance to breast milk and thereby improves nutrition, increases growth and reduces serious complications and mortality in this population. Beyond this, possible mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.

NCT ID: NCT01531179 Completed - Clinical trials for Necrotizing Enterocolitis

Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants

Start date: February 2012
Phase: Phase 3
Study type: Interventional

Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.

NCT ID: NCT01530828 Recruiting - Clinical trials for Necrotizing Enterocolitis

IRT in Infants With Intestinal Perforation

Start date: August 2010
Phase: N/A
Study type: Observational

This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. Analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. This study will target the group of infants at highest risk for IP, those with birth weight less than 1000 grams, within the time frame most likely to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate premature infants with and without intestinal perforation in the first 3 weeks of life.

NCT ID: NCT01441739 Recruiting - Clinical trials for Necrotizing Enterocolitis

Intestinal Failure in Necrotising Enterocolitis

Start date: September 2004
Phase: N/A
Study type: Observational

Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder with high morbidity and mortality (20-40%), affecting predominantly premature neonates. NEC continues to present a diagnostic challenge to clinicians. The initial clinical manifestations of NEC are non-specific and indistinguishable from other gastrointestinal disorders and sepsis. The first goal of this study is to find and evaluate tests to diagnose NEC at an early stage. For the development of new diagnostic markers, the investigators require knowledge of pathophysiological processes that underlie NEC, which still remain unclear. Therefore, the second goal of this study is to elucidate the etiology of NEC. Furthermore, understanding of the pathophysiology of NEC can offer the possibility to develop new therapeutical treatments.

NCT ID: NCT01441427 Completed - Clinical trials for Necrotizing Enterocolitis

Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial

Start date: January 2010
Phase: Phase 1/Phase 2
Study type: Interventional

With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human developmental biology. Among these roles, they have trophic actions on villous height and bowel length of the developing intestine.The aim of this study is to evaluate the efficacy of enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding intolerance and /or NEC in preterm infants.

NCT ID: NCT01340469 Completed - Clinical trials for Necrotizing Enterocolitis

Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants

Start date: January 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.

NCT ID: NCT01337921 Withdrawn - Clinical trials for Necrotizing Enterocolitis

A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants

Start date: June 2011
Phase: N/A
Study type: Interventional

The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2) compare infants successfully colonized with probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life, 34 weeks CGA on infant outcomes and on stress biomarker patterns at birth, day of life (DOL) 1, DOL 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and 24 months CGA.

NCT ID: NCT01336998 Active, not recruiting - Clinical trials for Necrotizing Enterocolitis

Administration of Arginine Supplementation in Preterm Infants

Start date: June 2009
Phase: N/A
Study type: Interventional

Calprotectin is a cytosolic component of neutrophils .Fecal calprotectin(FC) is a useful marker for exacerbation of inflammatory bowel disease in children .FC may be a useful marker for necrotizing enterocolitis (NEC). NEC is one of the most common ,deadliest and enigmatic intestinal problems encountered mostly in premature infants. The precise pathophysiology of NEC is unclear ,but major factors thought to play an important role include an immature intestine ,an inflammatory response to intestinal microbes,enteral feedings and intestinal ischemia-reperfusion injury.Diagnosis of NEC is not easy clinically and up to now there is not a simple laboratory test to differentiate NEC at an early stage from other conditions in the neonate. Arginine is the substrate for NO production in the gut and its deficiency may cause vasoconstriction and gut injury and thus predispose to NEC. In previous studies arginine supplementation was found to reduce the incidence of NEC in premature infants but more studies are needed for the use of arginine supplementation for the prevention of NEC. The investigators aim is to measure the fecal calprotectin in very low birth weight (VLBW) infants during the first month of life as an inflammatory marker of the bowel and evaluate whether premature infants receiving arginine supplements had lower calprotectin values compared to the premature infants that did not . The investigators hypothesize that arginine supplementation in preterm infants reduces the inflammation of the gut which will be shown by the lower fecal calprotectin values of the premature infants receiving arginine supplementation.