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Necrotizing Enterocolitis clinical trials

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NCT ID: NCT04921696 Withdrawn - Anemia Clinical Trials

Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis

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

Necrotizing enterocolitis (NEC) is a leading cause of mortality among preterm infants.The pathogenesis of NEC remains unclear with conflicting data regarding the role of red blood cell (RBC) transfusion and anemia. A meta-analysis of retrospective studies demonstrated an association between exposure to RBC transfusion and NEC(adjusted odds ratio, 2.0 [95% confidence interval, 1.6-2.5]). However, recent observational studies have found no association between RBC transfusion and NEC or have found RBC transfusion to be protective.

NCT ID: NCT04912453 Recruiting - Clinical trials for Necrotizing Enterocolitis

Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Necrotizing enterocolitis (NEC) is a devastating disease that affects the intestine of premature infants and is the most common surgical emergency in newborns. It is estimated that up to 10% of premature babies can suffer from this condition. Despite aggressive medical treatment, surgical intervention is necessary in up half of the cases for bowel necrosis or perforation and these often represent the more severe form of the disease. The advances in neonatal intensive care and surgical knowledge have resulted in improved survival rate in recent years. For NEC patients with severe disease (i.e.) those with intestinal perforation or gangrenous bowel not responding to medical therapy, surgery with resection of diseased segments is the treatment of choice. Traditional surgical approach would be to resect the diseased bowel segment with formation of enterostomy. However, in a few advanced centres, primary anastomosis after the resection of diseased bowel segment is practised. Retrospective reports of the primary anastomosis approach have shown that this is also a viable option with no increased rate of peri-operative morbidity. It also has the advantage of avoiding a second operation for enterostomy closure. Nonetheless, prospective studies comparing the two approaches are lacking. The proposed study will fill up the following knowledge gap on what the best surgical option for NEC at laparotomy is. The findings will help guide our practice for NEC patients in the future in order to provide them with the best possible and evidence-based care. In this study, the investigators hypothesize that neonates with major NEC undergoing primary anastomosis after surgical resection is not inferior to neonates who have enterostomy, in terms of peri-operative morbidities. Aim of the study is to compare the short term and medium term outcomes of NEC patients requiring surgical intervention who either receive primary anastomosis or enterostomy creation.

NCT ID: NCT04801537 Recruiting - Clinical trials for Necrotizing Enterocolitis

Temperature of Extremities and Necrotizing Enterocolitis

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

Bloody stool and necrotizing enterocolitis(NEC) is two main focus in non-neonatal intensive care unit ward and usually lead to longed duration of hospitalization. Neutral temperature is a environmental temperature where the infant's body temperature is normal under resting state, and the changes of body temperature and skin temperature are less than 0.2-0.3 centigrade. According the definition, a suggested temperature range is set. For example, if an infant's body weight is more than 2500 gram, the initial set of environmental temperature is 31.3 centigrade with a range of 29.8-32.8 centigrade. low environmental temperature is a risk factor for Bloody stool and NEC. Therefore, how to set the optimal environmental temperature is a challenge.

NCT ID: NCT04795453 Recruiting - Surgery Clinical Trials

Assessment of Score System of Surgery in Necrotizing Enterocolitis(NEC) Patients

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

Necrotizing enterocolitis(NEC) is one of the most serious disease in the newborn infants, and two and more grades of NEC usually lead to surgery, even death. But, it is difficult to predict when to operate the surgery.

NCT ID: NCT04696003 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

Treatment of Classic Mid-trimester PPROM by Means of Continuous Amnioinfusion

AmnionFlush
Start date: January 1, 2021
Phase: Phase 3
Study type: Interventional

Objective: Mid-trimester preterm premature rupture of membranes (PPROM), defined as rupture of fetal mem-branes prior to 28 weeks' gestation (WG), complicates approximately 0.4-0.7% of all pregnancies and associated with very high neonatal mortality and morbidity. Antibiotics have limited success to prevent bacteremia, chorioamnionitis and fetal inflammation because of reduced placental transport. The repetitive amnioinfusion doesn't work because of immediately fluid lost after the intervention). The continuous amnioinfusion with Amnion Flush Solution through the perinatal port system in patients with classic PPROM prolonged the PPROM-to-delivery interval to 49 days in average by flush out of bacteria and inflammatory components from the amniotic cavity. Aim: This multicenter trial tests the effect of continuous amnioinfusion on the neonatal survival without major morbidities, like severe bronchopulmonary dysplasia, intraventricular hemorrhage, cystic periventricular leukomalacia and necrotizing enterocolitis. Design: randomized multicenter controlled trial; two-arm parallel design. Control group: 34 PPROM patients between 22/0 (20/0) -26/0 WG treating with antibiotics and corticosteroids in according to DGGG guide-lines. In interventional group (n=34) the standard PPROM therapy will be complemented by "Amnion -Flush" method with the amnioinfusion of artificial amniotic fluid (Amnion Flush Solution, Serumwerk AG, Germany, 2400 ml/d). Subjects: Patients with classic PPROM between 22/0-26/0 WG. Expected outcome:The investigators expect significant reduction of neonatal mortality and morbidity in the "Amnion-Flush" group.

NCT ID: NCT04584320 Recruiting - Clinical trials for Necrotizing Enterocolitis

Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization

ECUN-2
Start date: October 18, 2021
Phase:
Study type: Observational

The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.

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: NCT04344639 Completed - Clinical trials for Necrotizing Enterocolitis

Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey

Start date: March 1, 2019
Phase:
Study type: Observational

Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC.

NCT ID: NCT04304807 Completed - Clinical trials for Necrotizing Enterocolitis

Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants

Start date: December 24, 2018
Phase: Phase 4
Study type: Interventional

Assesses the efficacy of melatonin in treatment of feeding intolerance in preterm infants, the time needed to reach full enteral intake, the incidence of necrotizing enterocolitis and measures the level of tumor necrosis factor-alpha as a marker of oxidative stress.

NCT ID: NCT04284280 Recruiting - Clinical trials for Necrotizing Enterocolitis

Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants

Start date: February 15, 2020
Phase: N/A
Study type: Interventional

The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.