Active clinical trials for "Gastroschisis"

The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days.

The goal of this clinical trial is to evaluate the safety and feasibility of fetal repair of complex gastroschisis (GS) via a fetoscopic surgical approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 patients. The hypothesis is that in utero repair of GS will reduce postnatal mortality and morbidity in complex GS infants with minimal maternal and fetal risk.

This study explores the use of an exclusive human milk diet versus standard feeding practices to compare the influence on feeding outcomes and the gut bacteria in infants with intestinal differences.

With an increasing body of evidence to support a causal link between drinking milk that contain cow's milk protein (CMP) and the development of gastrointestinal disturbance in infants, many clinicians avoid the use of CMP containing feed in high risk babies. Delivery of adequate nutritional intake is one of the great challenges in the care of newborn infants, particularly those born preterm or with gastrointestinal problems. Whilst there are recognised benefits of human milk, a diet of exclusive human milk may not meet the nutritional demands of the infant. To close this gap, breast milk fortifier (BMF) is typically added to human milk. However, addition of BMF may be associated with gastrointestinal disturbance, possibly due to the fact that it contains CMP. This research study is to test the tolerability and safety of a new human milk-based BMF in neonates with gastrointestinal problems. It is hoped that this may provide an opportunity for high risk infants, to receive the benefits of human milk whilst minimising the risks reported to be associated with CMP. Eligible infants will be those in whom nutritional supplementation of breast is deemed clinically necessary, a weight of greater than 1.0kg at the time of starting fortifier and at least one of: previous gastrointestinal surgery congenital gastrointestinal anomaly medically treated gastrointestinal disease previously suspected intolerance of CMP based breast milk fortifier in the absence of other gastrointestinal disease Infants will be started on human milk-based BMF once they are tolerating 100 mls per kilo per day of human breast milk. The human milk-based fortifier will be commenced at half the recommended dose for 48 hours then increase to full strength. This will be continued until the infant reaches 44 weeks corrected gestational age, or until such time as they are deemed to no longer require the additional nutrition.

Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome. This study will apply a novel type of non-invasive monitoring, called fetal magnetocardiography (fMCG) used thus far to successfully evaluate fetal arrhythmias, in order to discover potential hidden electrophysiologic abnormalities that could lead to fetal demise in five high-risk pregnancy conditions associated with fetal demise.

Adequate pain control, rehabilitation and early postoperative recovery are currently the model to follow according to the recommended guidelines.In this project the main objective is to evaluate 2 different analgesic strategies both intraoperatively and postoperatively, one based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior to surgical intervention in eventration or abdominal wall repair interventions. We conducted an observational study with a low level of intervention. Epidural analgesia prior to general anesthesia and serratus-intercostal block prior to general anesthesia) following the criteria applied in each case according to the operating room anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal eventration repair, over 18 years of age, ASA I-III. Signature of the IC.

Is there an indication for drainage in contact with a prosthesis placed in a retromuscular position, during a cure for abdominal wall ventration in adults? This procedure is very frequent in digestive surgery and can be associated with serious complications, notably prosthesis infection.

Gastroschisis is a congenital defect of the abdominal wall that leads to evisceration of various amounts of the abdominal organs. The mainstay of therapy is restoring continuity of the abdominal wall, either through primary closure or with a synthetic graft when primary closure is not feasible. It has been established that bowel function after repair of gastroschisis is impaired due to the aforementioned pathological processes. Previous studies have shown that the time from surgery to attaining full nutrition through enteral means is a predictor for morbidity in this population. Therefore, numerous therapeutic interventions have been proposed to help hasten bowel function and decrease the time to tolerance of total enteral nutrition. A common, but unproven, technique is the use of glycerin suppositories to stimulate bowel function. The concept of glycerin suppositories is that stimulating colonic activity through the use of the suppository will stimulate small intestinal function. The underlying concept is that improved bowel motility and reduced time to full enteral feeds will reduce the morbidity associated with this disease. While the formation/evacuation of stools is most easily monitored, the main purpose of using these suppositories is to hasten tolerance of nutrition through enteral means. While the practice of using glycerin suppositories is common in neonates, there is no literature or best-practice guidelines advocating for (or against) their use. A single previous prospective study utilizing glycerin suppositories in premature, low birth weight neonates failed to show any benefit in improving time to tolerate full enteral feeds. At this time, this is the only study investigating the use of glycerin suppositories in any neonatal population, and due to the indications (i.e. premature and low birth weight infants without surgical disease), the findings are not applicable to neonates with gastroschisis. To the authors' knowledge, there are no previous studies or current ongoing studies examining this question. Given this lack of information regarding the efficacy of glycerin suppositories, there is a significant variation in practice among practicing surgeons, including timing of initial administration, frequency of use, and indication to discontinue. Indeed the spectrum ranges from some surgeons who never use glycerin suppositories, to some who prescribe them daily for all gastroschisis patients immediately following surgery. The purpose of this study will be to determine whether routine use of glycerin suppositories improves bowel function as measured by time to full enteral feeds (primary outcome: defined as enteral feed volume >120mL/kg/day with appropriate weight gain (20-30g/day for two consecutive days)) in neonates with uncomplicated gastroschisis after complete reduction of abdominal viscera. Secondary outcomes include time to first bowel movement and incidence/severity of TPN-induced cholestasis in the study groups.

Gastroschisis is a rare abdominal wall defect. Though survival rate is high, there are significant complications related to feeding intolerance and infections. Recently, oral care with breast milk has been studied in extremely premature infants and has been shown to improve both feeding tolerance and protect against infection. Though only studied in premature infants, it is likely that other populations of patients can benefit form oral care as well. This is a prospective observational cohort study looking at infants with gastroschisis admitted to the Texas Children's Hospital Newborn Center NICU (level II and level IV) who receive oral care with mother's milk or sterile water when mother's milk is not available. The study is aimed to demonstrate the benefits of oral care with breast milk in infants with gastroschisis. Additionally, the investigators will evaluate how oral care with breast milk affects the intestinal bacterial environment and how oral care with breast milk affects the secretion of certain proteins from the salivary gland. Primary hypothesis: The primary objective is to compare the magnitude of increase in intestinal microbiota alpha diversity over a four week period between infants who receive oral care with mother's milk and those receiving oral care with sterile water using a paired analysis. Secondary hypothesis: Oral care with breast milk will decrease the days to start enteral feeds after primary surgical closure inpatients with gastroschisis. Oral care with breast milk will decrease the days to reach full enteral feeds of 140 cc/kg/day in patients with gastroschisis. Oral care with breast milk will decrease length of stay in patients with gastroschisis. Oral care with breast milk will increase secretion of certain proteins, such as vascular endothelial growth factor, from the salivary gland.

Infants with gastroschisis typically have poor intestinal motility for the first weeks to months after birth. Prokinetic agents are often used in these infants to improve intestinal motility in an attempt to quicken the attainment of enteric feeds. However, the evidence to support this practice remains weak. Investigators hypothesize that a prokinetic agent given intravenously (infused into a vein) may be effective in improving gut motility in children with gastroschisis.