View clinical trials related to Atresia; Bowel.
Filter by:The goal of this observational study is to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal diseases that appear during early life. The main questions aim to answer are: - to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal diseases that appear during early life. - is to investigate the development of the immune system in relation to enteral nutrition during the neonatal period. Participants will be asked to give faecal samples from day 1 of life and weekly for the following weeks until discharge (preterm infants). Further, surgery faecal samples and intestinal tissue will be collected proximal and distal to the pathology. In cases with a stoma, and when the child will undergo later reversal surgery, tissue samples from the proximal and distal ends of the intestine will be collected together with fecal samples (preterm and children up to 1 year of age who need to undergo intestinal surgery due to atresia).
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.