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Enterocolitis clinical trials

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NCT ID: NCT06202911 Active, not recruiting - Clinical trials for Necrotizing Enterocolitis

Effect of Oral N-Acetyl Cysteine in Prevention of Necrotizing Enterocolitis in Preterm Neonates With Feeding Intolerance

Oral NAC
Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

necrotizing enterocolitis is a dangerous disease that may be fatal especially in preterm neonates, the early features of the disease are symptoms of feeding intolerance and interruption of the baby's feeding plan , so prophylactic measures at this stage may help to prevent its progression and its complications. N-acetyl cysteine is an FDA- approved drug and has many uses in different diseases and in different age groups including neonates, it has a mucolytic and anti-inflammatory and anti-oxidant effects that are believed to break the bacterial biofilm which enables it to stick to the intestinal wall and also decrease the intestinal wall inflammation, therefore enhance the intestinal barrier and decrease the chance of bacterial invasion.

NCT ID: NCT06097767 Active, not recruiting - Clinical trials for Pharmacological Action of Drug

the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy

Start date: October 19, 2023
Phase: Early Phase 1
Study type: Interventional

It is a randomized, prospective study; it will be carried out in the NICU at Alzahraa University Hospital including 50 newborn babies diagnosed with respiratory distress syndrome. The purpose of this study is to : 1. Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants. 2. Detect the impact of caffeine protocol treatment on the in-incidence of necrotizing enterocolitis in respiratory distress syndrome preterm infants in neonatal intensive care 1- Control group It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks. 2- Caffeine-treated group It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.

NCT ID: NCT03978000 Active, not recruiting - Clinical trials for Necrotizing Enterocolitis

IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

Start date: July 4, 2019
Phase: Phase 3
Study type: Interventional

IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.

NCT ID: NCT03797157 Active, not recruiting - Sepsis Clinical Trials

Human Milk Fortification in Extremely Preterm Infants

N-forte
Start date: February 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomised controlled multi-centre trial comparing the effect of diet supplementation of a human breast milk-based nutrient fortifier (H2MF®) with standard bovine protein-based nutrient fortifier in 222 extremely preterm infants (born before gestational week 28+0) exclusively fed with human breast milk (own mother´s milk and/or donor milk). The infants will be randomised to receive either the human breast-milk based H2MF® or the standard bovine protein-based nutrient fortifier when oral feeds have reached <100 ml/kg/day. The randomised intervention, stratified by centre, will continue until the target gestational week 34+0. The infant must not be fed with formula during the intervention period. The allocation will be concealed before inclusion, but after randomisation the study is not blinded. Primary endpoint of the intervention is the composite variable necrotizing enterocolitis (NEC), sepsis and mortality. The enrolled infants are characterised with clinical data including growth, feeding intolerance, use of enteral and parenteral nutrition, treatment, antibiotics and complications collected daily in a study specific case report form from birth until discharge from the hospital (not longer than gestational week 44+0). A follow up focusing on neurological development, growth and feeding problems will be performed at 2 years of age (corrected) and 5.5 years of age.

NCT ID: NCT03717584 Active, not recruiting - Clinical trials for Bronchopulmonary Dysplasia

A Cohort Study of the Intestinal Microbiota of Premature Infants

Start date: December 23, 2018
Phase:
Study type: Observational

Premature infants are at risk for a variety of diseases, the investigators would like to learn more about why some premature babies are at higher risk and some are protected from these diseases. Scientists at UC Davis and other universities have developed new ways to measure the bacteria and a large number of small molecules in specimens of infant blood, urine, stomach fluid and poop and in mother's milk. These discoveries allow us to consider questions that were impossible to answer before these new techniques were developed. One such question is whether the bacteria in the poop of a premature baby can help us predict the baby's risk for developing infection or a common and serious disease of premature infants called necrotizing enterocolitis. A second question is whether the DNA of a premature baby (obtained from saliva with a q-tip) can predict higher risk for diseases of premature babies.

NCT ID: NCT03554278 Active, not recruiting - Clinical trials for Necrotizing Enterocolitis

Alteration of Stool Microbiota in Preterm Infants With Anemia

Start date: October 9, 2018
Phase:
Study type: Observational

This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.

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.

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: 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.