Clinical Research Directory

Early Feeds in Gastroschisis

This study aims to evaluate the feasibility of initiating early feeds in neonates with gastroschisis, a condition where infants are born with their intestines outside the body.

Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise

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.

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

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.

Oral Care in Infants With Gastroschisis

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.

Gastroschisis Outcomes of Delivery (GOOD) Study

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.

An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels

The SuNDiAL study will measure levels of two naturally occurring amino acids: Arginine and Asymmetric Dimethylarginine (ADMA) in neonates undergoing abdominal surgery in the first 5 days of life due to congenital abdominal malformations as the participants recover from surgery. The investigators hypothesise that the relationship between Arginine and ADMA may be useful in predicting recovery and complications in babies who have had abdominal surgery due to previous research published in adult patients undergoing abdominal surgery. If this relationship is found to be useful there may be options for developing treatments (such as arginine supplementation) in the future to improve recovery and reduce complications in neonates undergoing abdominal surgery. Neonates born after 35 weeks gestation who have a congenital abdominal malformation who require abdominal surgery in the first 5 days will be eligible to participate in the SuNDiAL study. Arginine and ADMA will be measured from blood samples that are left over from the participant's blood tests that are taken as part of their routine clinical care. The investigators will measure Arginine and ADMA preoperatively and at least 10 points in the 30 days following their surgery, or until the participant fully recovers from surgery (which ever comes first). There is no intervention in the SuNDiAL study, and there will be no extra blood or blood samples taken. Serums samples that are left over from the babies routine clinical blood tests will be stored securely in the hospitals laboratory until analysis for Arginine and ADMA. The levels of Arginine and ADMA will be compared to the time it takes the participants to recover from surgery and any complications that may arise following surgery. During the study the study team will use the participants electronic medical record to establish when the participant became fully established on oral feeding and monitor for any complications that occurred during their recovery.

MEGA STUDY - Multicenter Evaluation of Gastroschisis Anomaly Study

The purpose of this observational study is to evaluate selected epidemiological aspects of gastroschisis (GS) and factors affecting health outcomes of newborns with this diagnosis in a population of fetuses with gastroschisis. The main questions the study aims to answer are: * Are there correlations between the parameters of ultrasound evaluation of the bowel with the condition of the newborn's bowel as assessed by the surgeon? * What is the prevalence of the different forms of GS (classification according to the methodology of Molik et al. 2002, Perrone et al. 2018)? * What is the incidence of perioperative and postoperative complications and other complications of the neonatal period? * What is the relationship between the form of the defect (simple GS vs complex GS) and feeding milestones - TFEF, TPN, TSEF, TSOF, TFOF? * What is the relationship between clinical parameters, diagnostic and therapeutic management, including method and timing of delivery, and final outcomes? Participants will not perform any active tasks or receive interventions as part of this study. Data will be collected passively from historical medical records including prenatal test results, details of pregnancy, delivery, and postnatal information on the newborn's treatment. The information collected will be anonymized. The study aims to collect information on prenatal diagnosis and neonatal outcomes, analyze factors affecting final results, and develop the most optimal management regimen for GS in Poland.