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In this multicenter, randomized trial comparing primary peritoneal drainage with laparotomy for the management of perforated necrotizing enterocolitis in preterm infants with birth weights less than 1500 g, there were no significant differences between groups in mortality at 90 days, dependence on total parenteral nutrition at 90 days, or length of the hospital stay in surviving infants. These data do not support an advantage of either primary peritoneal drainage or laparotomy over the alternative approach among preterm infants with perforated necrotizing enterocolitis. This trial compared primary peritoneal drainage with laparotomy for the management of perforated necrotizing enterocolitis in preterm infants. There were no significant differences between groups in mortality at 90 days, dependence on total parenteral nutrition at 90 days, or length of the hospital stay in surviving infants. Necrotizing enterocolitis is a severe inflammatory disorder of the intestine occurring in premature infants. It is a major cause of death and morbidity in neonates. 1 In contrast to the improvements during the past 30 years in the outcomes of many conditions affecting premature infants, the mortality rate of 30 to 50 percent for babies with intestinal perforation due to necrotizing enterocolitis remains essentially unchanged. 2 The standard approach to patients with perforated intestine, necrotic intestine, or both is surgical resection of the involved bowel with the creation of intestinal stomas. In a critically ill premature infant, this entails substantial risks. Primary . . .

Objective: Earlier diagnosis and treatment of necrotizing enterocolitis (NEC) in preterm infants, before clinical deterioration, might improve outcomes. A monitor that measures abnormal heart rate characteristics (HRC) of decreased variability and transient decelerations was developed as an early warning system for sepsis. As NEC shares pathophysiologic features with sepsis, we tested the hypothesis that abnormal HRC occur before clinical diagnosis of NEC. Study Design: Retrospective review of Bells stage II to III NEC cases among infants <34 weeks gestation enrolled in a prospective randomized clinical trial of HRC monitoring at three neonatal intensive care units. Result: Of 97 infants with NEC and HRC data, 33 underwent surgical intervention within 1 week of diagnosis. The baseline HRC index from 1 to 3 days before diagnosis was higher in patients who developed surgical vs medical NEC (2.06±1.98 vs 1.22±1.10, P =0.009). The HRC index increased significantly 16 h before the clinical diagnosis of surgical NEC and 6 h before medical NEC. At the time of clinical diagnosis, the HRC index was higher in patients with surgical vs medical NEC (3.3±2.2 vs 1.9±1.7, P <0.001). Conclusion: Abnormal HRC occur before clinical diagnosis of NEC, suggesting that continuous HRC monitoring may facilitate earlier detection and treatment.

Objective Necrotising enterocolitis (NEC) is a major source of neonatal morbidity and mortality. The management of infants with NEC is currently complicated by our inability to accurately identify those at risk for progression of disease prior to the development of irreversible intestinal necrosis. We hypothesised that integrated analysis of clinical parameters in combination with urine peptide biomarkers would lead to improved prognostic accuracy in the NEC population. Design Infants under suspicion of having NEC (n=550) were prospectively enrolled from a consortium consisting of eight university-based paediatric teaching hospitals. Twenty-seven clinical parameters were used to construct a multivariate predictor of NEC progression. Liquid chromatography/mass spectrometry was used to profile the urine peptidomes from a subset of this population (n=65) to discover novel biomarkers of NEC progression. An ensemble model for the prediction of disease progression was then created using clinical and biomarker data. Results The use of clinical parameters alone resulted in a receiver-operator characteristic curve with an area under the curve of 0.817 and left 40.1% of all patients in an ‘indeterminate’ risk group. Three validated urine peptide biomarkers (fibrinogen peptides: FGA1826, FGA1883 and FGA2659) produced a receiver-operator characteristic area under the curve of 0.856. The integration of clinical parameters with urine biomarkers in an ensemble model resulted in the correct prediction of NEC outcomes in all cases tested. Conclusions Ensemble modelling combining clinical parameters with biomarker analysis dramatically improves our ability to identify the population at risk for developing progressive NEC.

PurposeRemote ischemic conditioning (RIC) is a maneuver involving brief cycles of ischemia reperfusion in an individual’s limb. In the early stage of experimental NEC, RIC decreased intestinal injury and prolonged survival by counteracting the derangements in intestinal microcirculation. A single-center phase I study demonstrated that the performance of RIC was safe in neonates with NEC. The aim of this phase II RCT was to evaluate the safety and feasibility of RIC, to identify challenges in recruitment, retainment, and to inform a phase III RCT to evaluate efficacy.MethodsRIC will be performed by trained research personnel and will consist of four cycles of limb ischemia (4-min via cuff inflation) followed by reperfusion (4-min via cuff deflation), repeated on two consecutive days post randomization. The primary endpoint of this RCT is feasibility and acceptability of recruiting and randomizing neonates within 24 h from NEC diagnosis as well as masking and completing the RIC intervention.ResultsWe created a novel international consortium for this trial and created a consensus on the diagnostic criteria for NEC and protocol for the trial. The phase II multicenter-masked feasibility RCT will be conducted at 12 centers in Canada, USA, Sweden, The Netherlands, UK, and Spain. The inclusion criteria are: gestational age < 33 weeks, weight ≥ 750 g, NEC receiving medical treatment, and diagnosis established within previous 24 h. Neonates will be randomized to RIC (intervention) or no-RIC (control) and will continue to receive standard management of NEC. We expect to recruit and randomize 40% of eligible patients in the collaborating centers (78 patients; 39/arm) in 30 months. Bayesian methods will be used to combine uninformative prior distributions with the corresponding observed proportions from this trial to determine posterior distributions for parameters of feasibility.ConclusionsThe newly established NEC consortium has generated novel data on NEC diagnosis and defined the feasibility parameters for the introduction of a novel treatment in NEC. This phase II RCT will inform a future phase III RCT to evaluate the efficacy and safety of RIC in early-stage NEC.

BackgroundMore effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. The trial used simplified opt-out consent with concise parent information and no consent form.ObjectiveTo explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials.MethodsA qualitative, descriptive interview-based study nested within a randomised trial. Semistructured interview transcripts were analysed using inductive thematic analysis.SettingEleven neonatal units in England.ParticipantsEleven parents and ten health professionals with experience of simplified consent.ResultsFive themes emerged: ‘opt-out consent operationalised as verbal opt-in consent’, ‘opt-out consent normalises participation while preserving parental choice’, ‘opt-out consent as an ongoing process of informed choice’, ‘consent without a consent form’ and ‘choosing to opt out of a comparative effectiveness trial’, with two subthemes: ‘wanting “normal care”’ and ‘a belief that feeding is better’.ConclusionIntroducing a novel form of consent proved challenging in practice. The principle of a simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as ‘opt-out’ can help to normalise participation and emphasise that parents can withdraw consent.

The human intestinal microbiota, establishing a symbiotic relationship with the host, plays a significant role for human health. It is also well known that a disease status is frequently characterized by a dysbiotic condition of the gut microbiota. A probiotic treatment can represent an alternative therapy for enteric disorders and human pathologies not apparently linked to the gastrointestinal tract. Among bifidobacteria, strains of the species Bifidobacterium breve are widely used in paediatrics. B. breve is the dominant species in the gut of breast-fed infants and it has also been isolated from human milk. It has antimicrobial activity against human pathogens, it does not possess transmissible antibiotic resistance traits, it is not cytotoxic and it has immuno-stimulating abilities. This review describes the applications of B. breve strains mainly for the prevention/treatment of paediatric pathologies. The target pathologies range from widespread gut diseases, including diarrhoea and infant colics, to celiac disease, obesity, allergic and neurological disorders. Moreover, B. breve strains are used for the prevention of side infections in preterm newborns and during antibiotic treatments or chemotherapy. With this documentation, we hope to increase knowledge on this species to boost the interest in the emerging discipline known as “therapeutic microbiology”.

Background Necrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants. Methods The study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age. Results A total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p  = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p  = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p  = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks ( p  = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l ( p  = 0.000) and 5 min Apgar score > 5 ( p  = 0.028). Conclusion Repeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants. Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500

Necrotizing enterocolitis, one of the most common and devastating diseases in neonates, typically manifests with feeding intolerance, abdominal distention, and bloody stools. This article discusses the current knowledge and treatment of this difficult-to-treat condition. Necrotizing enterocolitis is among the most common and devastating diseases in neonates. It has also been one of the most difficult to eradicate 1 and thus has become a priority for research. 2 Conditions closely resembling necrotizing enterocolitis were described before the 1960s, but the entity was not widely recognized until after the advent of modern neonatal intensive care. 1 Since that time, the incidence of necrotizing enterocolitis and the associated morbidity and mortality have remained unchanged because of ever-improving survival of the smallest infants; in some instances, these rates have actually increased. On the basis of large, multicenter, neonatal network databases from . . .

Necrotizing enterocolitis (NEC) is a gastrointestinal emergency of the neonatal period. The aim of this study was to demonstrate the use of multistrain and multispecies probiotic on gastrointestinal morbidities and mortality. The study was organized as a randomized controlled, prospective study in premature infants (≤32 week and ≤1500 gram). The ready commercial preparations which contain multi-combined probiotics of Lactobacillus rhamnosus (4.1x108 cfu) + Lactobacillus casei (8.2x108 cfu) + Lactobacillus plantorum (4.1x108 cfu) + Bifidobacterium animalis (4.1x108 cfu) together with 383 mg of fructooligosaccharides and 100 mg of galactooligosaccharides as the prebiotic content, was administered enterally to the probiotic group (n=70); control group constituted of 40 preterms. Primary outcomes of the present study were ≥ Stage 2 NEC and the mortality. Secondary outcomes were culture-proven sepsis and days to reach full enteral feeding. All cases of NEC were seen in group 2 as 3.6% (n=4) of all infants. The mortality was found to be 1.4% (n=1) in Group 1 and 22.5% (n=9) in Group 2. The incidence of NEC and the mortality rate were found to be significantly lower in Group 1 (p=0.016, p=0.001, respectively). In Group 1, the NEC-related mortality rate and sepsis-related mortality rate were significantly lower than that of the control group (p=0.046, p=0.023). In this study, we showed that using probiotic strains in combined multistrain and multispecies forms at higher doses and for prolonged duration had positive effects on gastrointestinal complications, sepsis and mortality in premature infants.

Necrotizing enterocolitis (NEC) is a significant cause of morbidity and mortality for preterm infants in the neonatal intensive care unit. From the first surgical approaches for NEC in the 1970s and the development of Bell’s staging criteria, there has been a continuous medical and scientific journey towards understanding the pathophysiology, clinical progression, and treatment possibilities for this devastating disease. Basic science research has played a crucial role in understanding the pathogenesis of NEC. In vivo NEC models, which include rodents (mice, rats) and pigs, and in vitro NEC models, which utilize intestinal cell lines and organoids, have identified critical disease biomarkers, pathways in NEC pathogenesis, and novel therapeutic targets. These potential therapies have been brought into clinical trials to improve treatment options for infants with NEC. This review will provide a comprehensive assessment of research conducted over the last decade, leading to a deeper understanding of the disease’s development and progression through the use of innovative models, the identification of novel biomarkers, the development of new therapeutic approaches, and, finally, an overview of the latest clinical trials. We will conclude with a discussion of ongoing challenges and future research directions, highlighting the optimism and hope that these advancements bring to the field of neonatology and pediatric surgery. This review will serve as a reference and guide for future NEC research, with the ultimate goal of enhancing clinical outcomes and improving the quality of life for patients with NEC and their families.