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Enterocolitis clinical trials

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NCT ID: NCT04549727 Not yet recruiting - Prematurity Clinical Trials

Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of NEC

Start date: November 1, 2020
Phase:
Study type: Observational

Despite a greater understanding of NEC physiopathology, modest progress has been done in terms of intervention and prevention of the disease over the past three decades, being the mortality rate unchanged. Investigators intend to leverage our knowledge and technical expertise developed with fetal enteroids to further investigate the processes leading to NEC by deriving and performing functional studies on human intestinal enteroids generated from intestinal resection for therapeutic reasons in NEC and non-NEC patients 1. Generate a tissue biorepository composed of: enteroids and other lamina propria cells 2. Comparative studies of the gene expression profile of tissue, epithelial enteroids and underlying lamina propria of NEC, non-NEC, hypoxic and non-hypoxic infants 3. In vitro functional studies for the evaluation of critical factors in NEC pathophysiology 4. In vitro functional studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions 5. Correlative studies of the impact of perinatal variables on the intestinal barrier functionality at baseline and challenged with pathogens 6. In vitro comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants 7. Validation the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC

NCT ID: NCT04541771 Not yet recruiting - Sepsis Clinical Trials

The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants

NEC
Start date: October 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the effectiveness of L. Reuteri with placebo in prevention of NEC in children, as according to my knowledge, there is limited work is done nationally and internationally. Probiotics are being used in our Children Hospital and the Institute of Child Health, Multan. Route of administration of L. Reuteri will be oral or via nasogastric tube due to availability of oral form in Pakistan. The results of this study will be helpful to assess the beneficial effects of probiotics especially L. Reuteri in NEC in preterm. So, they can be recommended as preventive strategy to avoid NEC development and its complications based on its availability, effectivity and easy administration

NCT ID: NCT04213976 Not yet recruiting - Clinical trials for Hirschsprung Disease

Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis

StomaPed
Start date: January 1, 2020
Phase:
Study type: Observational

Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine. The traditional loop ileostomy has recently be challenged by ileostomies in continuity, either the Santulli or the Bishop-Koop one, that both decompresses the proximal dilated bowel and allow intestine fluid to pass through the underlying ileal anastomosis. Nevertheless, to date, no evaluation of their indications, complications and potential benefits has been made. The aim of this study is to retrospectively compare the outcomes of loop ileostomies and ileostomies in continuity in a paediatric population. It is thus expected to better define the specific indications for these different types of ileostomies in the paediatric and neonatal population.

NCT ID: NCT04073342 Not yet recruiting - Neonatal Disease Clinical Trials

Intestinal Genes Expression Associated With Necrotizing Enterocolitis

Start date: January 1, 2020
Phase:
Study type: Observational

In recent days, necrotizing enterocolitis is one of the most common and devastating problem in preterm infants. Therefore, it became a high growing research topic in the last decade. The development of medical care increases the survival of preterm babies and consequently increase the number of cases with this serious problem. A systematic review shows the incidence of necrotizing enterocolitis is about 2-7% in babies less than 32weeks gestation and 5-22% in baby's birth weight less than 1000gram.

NCT ID: NCT04050488 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

Zinc Supplementation on Very Low Birth Weight Infant

Start date: August 20, 2019
Phase: Phase 4
Study type: Interventional

Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the Intrauterine Growth Restriction (IUGR) group compared to the non-IUGR group. Other factors that also play a role are long episodes of fasting, the fulfillment of nutrition (macro and micronutrients) from the start, time to start breastfeeding (ASI), duration of parenteral total administration, the incidence of respiratory distress syndrome and incidence of necrotizing enterocolitis. Zinc is one of the micronutrients which is very risky for deficiency in premature babies. Babies with zinc deficiency experience growth disorders as much as 67%. In India, infants who received zinc supplementation increased after being given 10 days of zinc supplementation and lower mortality rates in the group with supplementation. Very low birth weight babies and bronchopulmonary dysplasia who received zinc supplementation during the week showed good clinical progress and the growth rate also increased. The investigators believe this study has the potential for decreasing infant mortality from its current level and can be a growth indicator for preterm babies.

NCT ID: NCT03700957 Not yet recruiting - Clinical trials for Necrotizing Enterocolitis

The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates

Start date: October 2018
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03593252 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Bowel Preparation in Elective Pediatric Colorectal Surgery

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Infections after elective intestinal surgery remain a significant burden for patients and for the health care system. The cost of treating a single surgical site infection is estimated at approximately $27,000. In adult patients, there is good evidence that the combination of oral antibiotics and mechanical bowel preparation is effective at reducing infections after intestinal surgery. In children, the body of evidence is much weaker. In this population, little evidence exists for oral antibiotics reducing infections and no data exists as to the effect of combining antibiotics with mechanical bowel preparation (such as polyethylene glycol (PEG)). The goal of the proposed study is to examine the effects of oral antibiotics with and without the combined use of mechanical bowel preparation on the rate of post-operative infectious complications in children aged 6 months to 18 years. This will be compared to the institution's current standard of care, which is to abstain from any type of mechanical bowel preparations or oral antibiotic administration before intestinal surgery.

NCT ID: NCT03257553 Not yet recruiting - Clinical trials for Necrotizing Enterocolitis

Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis

Start date: April 2018
Phase: N/A
Study type: Interventional

Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants due to advances in neonatal intensive care that increase the survival rate of extremely low birth weight infants (below 1,000 gram)

NCT ID: NCT03188380 Not yet recruiting - Clinical trials for Necrotising Enterocolitis

Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.

Start date: January 1, 2021
Phase:
Study type: Observational

Background Necrotizing enterocolitis (NEC) is one of the most serious conditions in newborns, affecting up to 10% of very low birth weight infants (VLBW). In the most premature population mortality rates can rise as high as 60%. Typical findings on abdominal radiography (AR) include pnuematosis intestinalis (PI), portal vein gas (PVG) and pneumoperitoneum, but are sometimes not present even in severe cases. Abdominal ultrasound (AUS) can depict PI, PVG and pnuemoperitoneum (in some cases a head of AR), but it also provides other crucial information such as bowel wall viability (thickness or thinning) and free abdominal fluid. These additional findings are helpful in expediting diagnosis and management of NEC. Methods and analysis The hypothesis being tested is that preforming an AUR in patients with clinical symptoms of NEC but inconclusive/normal AR will enhance detection rates, and expedite treatment in infants born at <32 weeks. Discussion The use of AUS together with AR as an add-on test may increase the accuracy of diagnosing NEC, and precipitate treatment. Swift implementation of antibiotics and bowel rest is extremely important. To our best knowledge, our study will be the first to focus only on VLBW, who are most prone to NEC. It will also be the first multi-centre study evaluating the use of AUS as an add-on test, enabling us to recruit a significantly higher number of patients compared to published studies.

NCT ID: NCT02872350 Not yet recruiting - Preterm Infants Clinical Trials

Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.

ECUN
Start date: October 2016
Phase: N/A
Study type: Interventional

Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants. The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the diagnosis. The prognostic value of these radiographic findings is currently controversial. Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to be considered for some years. It also has other advantages, including that of not being a radiating examination. Studies on the prognostic value of abdominal ultrasound are rather few. Moreover, they involve a series of heterogeneous patients in terms of gestational age. Or the pathophysiology of ECUN in children born at term and in children born prematurely is not the same. The objective is to study prospectively the prognostic contribution of abdominal ultrasound in the ECUN in premature under 33SA.