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Enterocolitis, Necrotizing clinical trials

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NCT ID: NCT03278847 Completed - Clinical trials for Necrotizing Enterocolitis

Optimising Newborn Nutrition During Therapeutic Hypothermia.

Start date: January 1, 2010
Phase:
Study type: Observational

The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia. To do this the investigators will perform two primary comparisons: 1. ENTERAL: to determine whether any enteral (milk) feeding, when compared to withholding enteral feeding (no milk), during therapeutic hypothermia, is associated with a difference in the incidence of necrotising enterocolitis. 2. PARENTERAL: to determine whether provision of intravenous dextrose, when compared to provision of parenteral nutrition, during therapeutic hypothermia, is associated with a difference in the incidence of blood stream infection. The investigators will use de-identified data held in an established research database called the National Neonatal Research Database (NNRD) and we will use the potential outcomes framework with application of propensity scoring to define matched subgroups for comparison.

NCT ID: NCT03258957 Completed - Clinical trials for Necrotizing Enterocolitis

Pilot Study of the Feasibility of Feeding Preterm Infants With Fresh Versus Frozen Mother's Own Breast Milk in the NICU

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Necrotizing enterocolitis (NEC) is a severe inflammatory disorder of the intestine that primarily affects very low birth weight (<1,500 g)/very preterm infants (≤32 weeks' gestation); it is also the leading cause of death in the neonatal intensive care unit (NICU).Perhaps the best form of treatment for NEC is prevention. Mother's breast milk is best for preventing NEC. Breast milk contains both nutritional components (proteins, amino acids, fats, carbohydrates, vitamins, and minerals) and bioactive components (macrophages, T cells, cytokines, hormones, and growth factors) that have antimicrobial and anti-inflammatory properties.The current NICU breast milk feeding procedure exists as a means of ensuring that infants have consistent access to their mother's breast milk even if the mother is not able to spend time in the NICU. The process also allows for stricter quality and infection control, as well as computerised inventory and monitoring via electronic health records.However, the process deprives infants of the benefits of the cellular content of breast milk, including the stem cells.The primary objective of this study isto evaluate the feasibility and safety ofproviding very preterm infants (born at <30 weeks' gestation) with fresh milk (within 4 hours of expression).While we acknowledge that as a pilot the study will not be powered to detect a statistically significant difference, our secondary objective is to identify if this approach has the potential to improve infant outcomes, particularly with regards to the occurrence of NEC. Our hypothesis is that it is feasible for many mothers to provide at least 1 feed of fresh breast milk (<4 hours post expression per day, and is not frozen, chilled or pasteurized) and that this may decrease the prevalence of NEC

NCT ID: NCT03136172 Completed - Hypotension Clinical Trials

Monitoring of Systemic or Organ Perfusion for Preterm Infants

Start date: May 8, 2017
Phase:
Study type: Observational

To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants. It includes near-infrared spectroscopy (NIRS), pulse oximetry with perfusion index (PI) and pleth variability index (PVI) and functional echocardiography.

NCT ID: NCT03111329 Completed - Prematurity Clinical Trials

Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence Time Taken to Reach Full Enteral Feeding?

GRASS
Start date: October 6, 2017
Phase: N/A
Study type: Interventional

The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications, such as feeding intolerance, necrotizing enterocolitis, sepsis etc.

NCT ID: NCT03091907 Completed - Complications Clinical Trials

Long-term Consequences of Necrotizing Enterocolitis in the Newborn Period

Start date: August 5, 2017
Phase:
Study type: Observational

Aim The aim of this study is to determine consequences at school age of the diagnosis of NEC in the neonatal period. Methods This is a case-control study, with case-group being children born in Denmark with a history of NEC and control-group being age-, gestational age- and year of birth matched children born in Denmark with no history of NEC. Primary outcome Abnormal or borderline 'total difficulties score' in the strenghts-and-difficulties-questionnaire as assessed by parents.

NCT ID: NCT03085277 Completed - Clinical trials for Necrotizing Enterocolitis

Bovine Colostrum for Preterm Newborns

PreColos-RCT
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Feeding intolerance is a common problem in very preterm infants due to their immature digestive system. This intolerance extends the time to full enteral feeding and thereby also prolongs the time on parenteral nutrition (PN). Prolonged time to full enteral feeding may predispose these infants to a higher risk of growth retardation, infections and organ dysfunctions (e.g. liver, brain). Mother's own milk (MM) is considered the optimal nutrition for preterm infants and is superior to infant formula (including preterm formula, PF) in stimulating gut maturation, feeding tolerance, resistance against necrotizing enterocolitis (NEC) and late-onset sepsis (LOS), and long-term neurodevelopmental outcomes. However, MM is often absent, or not available in sufficient amounts, during the first days or weeks after preterm delivery. Human donor milk (DM) is probably a better supplement to MM than PF, but DM is not available for all hospitals. To supplement insufficient MM during the early neonatal period in hospital settings with no access to donor milk, we suggest that bovine colostrum (BC) may be used instead of PF for very preterm infants during early life. BC, the first milk from cows after birth, is a rich source of protein and bioactive components, including lactoferrin, lysozyme, lactoperoxidase, immunoglobulins, and various growth factors, such as IGF-I and -II, EGFs, and TGF-β. BC has repeatedly been shown to improve gut maturation and NEC/LOS resistance in a well-established piglet model of preterm infants. We suggest a randomized, controlled trial to investigate the effects of BC vs. PF, supplemented to MM during the first 2 weeks, on the time to full enteral feeding in very preterm infants.

NCT ID: NCT02971566 Completed - Clinical trials for Placental Insufficiency

Splanchnic Oxygenation Response to Enteral Feeds in Preterm Infants With Abnormal Antenatal Doppler.

AREDF-SO
Start date: February 2013
Phase: N/A
Study type: Observational

Antenatal absent or reversed end-diastolic flow (AREDF) velocity through the umbilical arteries places preterm infants at significant risk for developing gastrointestinal complications, such as feeding intolerance, necrotizing enterocolitis or spontaneous intestinal perforation. Due to the fear of the aforementioned conditions, the establishment of adequate enteral feeds is frequently hampered in this population. Previous postnatal Doppler studies have shown that AREDF preterm infants who later developed feeding intolerance have a decreased blood flow velocity in the superior mesenteric artery in response to the first enteral feed; to date, however, it is not known whether this hemodynamic impairment persists over time, or if it is associated with reduced splanchnic oxygenation and perfusion, monitored by Near-infrared spectroscopy (NIRS). This observational prospective study aims: - to assess the patterns of abdominal oxygenation and perfusion in response to enteral feeds in AREDF preterm infants at different phases of enteral feeding establishment; - to evaluate a possible correlation with the development of gastrointestinal complications.

NCT ID: NCT02784821 Completed - Clinical trials for Bronchopulmonary Dysplasia

Antibiotic "Dysbiosis" in Preterm Infants

Start date: January 16, 2017
Phase: Phase 2
Study type: Interventional

Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing enterocolitis (NEC), late-onset sepsis, bronchopulmonary dysplasia (BPD), and mortality. The hypothesis is that early and prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities. It is possible that the effect of this widespread antibiotic use outweighs the potential benefits. This study will randomize preterm infants born at less than 33 weeks gestation to either pre-emptive antibiotics or no-pre-emptive antibiotics. The purpose of this research is to evaluate the risks and benefits of current practice to determine optimal levels of antibiotic use that protects the babies from infection with minimal effect on the microbiome and subsequent adverse outcomes related to overuse of antibiotics.

NCT ID: NCT02650869 Completed - Clinical trials for Necrotizing Enterocolitis

Role of Probiotics for Prevention of NEC in Preterm VLBW Infants

Probiotics
Start date: July 2012
Phase: Phase 3
Study type: Interventional

This prospective randomized double-blind control trial is carrying out in the neonatal unit of Sylhet MAG Osmani Medical College Hospital, Sylhet between July 2012 to December 2015 with the diagnosis of preterm (<33 weeks gestation) VLBW (birth weight <1500g) and fulfilling the inclusion criteria (able to tolerate oral feed and survive beyond 48h of life) were included in this study. Babies with suspicion of clinical sepsis, presence of perinatal asphyxia, major congenital anomaly and babies who expired due to other neonatal illness were excluded. Gestation was assessed from history of last menstrual period and after birth by new Ballard scores. A study protocol was approved by the Institutional Ethics Committee of Sylhet M.A.G Osmani Medical College, Sylhet.

NCT ID: NCT02477423 Completed - Clinical trials for Premature Birth of Newborn

A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome

Start date: July 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.