View clinical trials related to Gastroschisis.
Filter by:Some babies require emergency surgery on their tummy in the first few months of life. This is most commonly because they were born prematurely and developed a bowel problem (called NEC) or a blockage of the bowel. As part of this surgery, the ends of the bowel may be brought to the skin surface (called a stoma) to divert stool into a bag. The stoma allows time for the bowel to rest and recover and is intended to be temporary with reversal later on. The best time to reverse or "close" the stoma is unknown. Stomas may cause dehydration, poor growth and skin problems so earlier closure may be betterĶ¾ however surgery is safer when babies are older and bigger so later closure may be better. This study aims to answer the question, 'is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' It has a series of specific objectives which incorporate: (i) describing current UK practice; (ii) establishing whether or not a clinical trial (and exactly what form of trial) is acceptable to parents and clinicians; and (iii) establishing the design of a potential trial, including defining the intervention ('early vs. late') and the population of infants to be included, how infants should be recruited and what information should be collected (outcomes). The investigators will ask parents and health professionals for their views and whether they would take part in a future trial and information about babies who have recently had a stoma to find out which factors influence the timing of closure. They will also analyse 6 years of data from an existing database, the National Neonatal Research Database to estimate the numbers of babies affected, understand current practice and outcomes for these babies to help decide whether a clinical trial is possible.
Background: Intestinal resections are commonly performed in the pediatric population. Perfusion of the bowel is one of the most important factors determining the viability of an intestinal anastomosis. Up to date, no ideal method to assess intestinal perfusion has proven its superiority. Objectives: Primary: The aim of this study is to establish the feasibility and impact of the use of indocyanine green technology on intestinal resection margins during elective and emergency pediatric surgeries. Secondary: The secondary outcomes of interest include collection of adverse events and difficulties encountered with the use of the indocyanine green (ICG) technology. Postoperative surgical complications will also be recorded. Study Design: An open observational clinical study will be performed by using a clinical drug (indocyanine green) and medical device (SPY Fluorescence Imaging) to assess intraoperatively intestinal perfusion in a specific pediatric population.
Examination of the health-related quality of life of patients operated on due to congenital defects of the abdominal wall after birth with the questionnaires KINDL, SDQ and SF-36.
This study is a multi-centre, international, prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.
Gastroschisis is one of the most common neonatal surgical conditions, and is increasing in incidence. Postnatal bowel ischemia leading to necrosis, bowel loss and short-bowel syndrome, occurs in a few instances, with significant impact. Intestinal gangrene occurs in up to 37%. The cause of the gangrene can be multifactorial. Contributing factors can be volvulus; venous engorgement with ensuing arterial compromise; constriction of the gut mesentery at the defect; and contribution of the hydrostatic effect of the column of bowel within a silo. Theoretically, the increased hydrostatic pressure incurred by the bowel in a preformed silo, may decrease blood flow to the apex of the bowel and contribute to ischemia. However, this does not seem to be the norm, as most cases do well in the silo. Cases of intestinal ischaemia within the silo have been described in patients. Any objective measure of bowel perfusion and therefore viability which can aid clinical assessment and management may benefit patient outcome. Near-infrared spectroscopy (NIRS) is used to noninvasively measure and monitor changes in the approximate regional haemoglobin oxygen saturation (SO2) in the blood. Measurement of oxygen saturation using NIRS is already in clinical application in other neonatal and paediatric medical and surgical diseases. NIRS has been recommended as a good trend indicator of changes in neonatal tissues oxygenation. NIRS-measured duration of cerebral oxygen desaturation is an accurate predictor of postoperative neurological injury in children undergoing cardiac surgery. The investigators propose to use NIRS to measure SO2 in the intestinal bed in patients with gastroschisis and to ascertain if there is any clinical advantage to routine monitoring in these patients. The aim of the study will be to: 1. Measure Gastrointestinal SO2 (GSO2) of the bowel within the silo of gastroschisis patients 2. Identify the clinical progress of patients with gastroschisis in the postnatal period 3. Identify any association of the measured GSO2 with the clinical outcome and any gastrointestinal complications
The purpose of this pilot study is to evaluate a feeding technique, sham feeding, to promote adequate oral skills in order to prevent oral aversion and/or poor oral skills due to the delay in oral feeds for surgical reasons. Sham feeding is intended for infants who are expected to have a prolonged course without normal enteral feeding by mouth.
Background: Five billion people worldwide do not have access to safe, affordable surgical care. A significant proportion live in sub-Saharan Africa (SSA), where up to 50% of the population are children. There is limited literature on neonatal and paediatric surgery in SSA and children's surgery does not appear on any of the National Health Strategic Plans for the 47 independent countries across SSA. Objectives: To form a collaboration of surgeons and allied health professionals involved in children's surgery across SSA and collectively undertake the largest prospective cohort study of paediatric surgery in this region. Materials and Methods: Data will be collected via REDCap website on all patients with gastroschisis, anorectal malformation, appendicitis, inguinal hernia and intussusception, during a 1-month period of collaborators choice between October 2016 to April 2017, with a 30-day follow up until the end of May 2017. Estimated study population: 1450 patients from 50 institutions. Full ethical approval has been granted by the host centre; local ethical approval will be required at collaborating centres for participation. All collaborators will be co-authors. Primary outcome will be in-hospital all-cause mortality. Secondary outcomes will include post-intervention complications. Data will be collected on institutional facilities, patient demographics, duration from condition onset to presentation, peri-operative resuscitation, intervention and outcome. Differences in outcomes between SSA and benchmark data from high-income countries will be calculated using chi-squared analysis. Multi-level multivariate logistic regression analysis will be used to identify interventions and peri-operative factors associated with improved outcomes; p<0.05 will be deemed significant. Outcome: Results will be used to advocate for enhanced children's surgical services in SSA. We shall identify context-appropriate interventions associated with improved outcome. The collaboration will help to enhance research capacity in the region.
The purpose of this study is to determine which type of food results in a shorter hospital stay and better overall outcome for babies born with gastroschisis.
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
The objective of this study is to scientifically evaluate two different closure strategies for gastroschisis to determine if there is a difference in the two approaches.