[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroschisis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroschisis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,39,68,90,116,166],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100268501","gastroschisis-outcomes-of-delivery-good-study-100268501",false,"NCT02774746","Gastroschisis Outcomes of Delivery (GOOD) Study","Inclusion criteria:\n\nTo be eligible for study inclusion, subjects are required to meet the following criteria:\n\n1. Speak English or Spanish\n2. Age of ≥18 years old\n3. Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33 weeks gestation\n4. Have a singleton pregnancy\n5. Capable of providing written informed consent for study participation\n6. Established Estimated Date of Confinement (EDC) prior to 22 0\u002F7 weeks GA by last menstrual period (LMP) with ultrasound confirmation or ultrasound dating when LMP is unknown.\n\nExclusion criteria:\n\nSubjects will be excluded from enrollment for any of the following criteria\n\n1. Fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another congenital structural abnormality (if known; no additional testing required for research participation)\n2. Severe intrauterine growth restriction \u002F fetal growth restriction (defined as growth below the 5th percentile for gestational age)\n3. Maternal history of previous stillbirth (intrauterine fetal demise)\n4. Maternal history of spontaneous preterm (\\\u003C36 weeks) delivery\n5. Maternal cervical length \\\u003C 25 mm prior to 24 weeks of gestation if documented\n6. Maternal hypertension\n7. Maternal insulin-dependent diabetes\n8. Prenatal care initiated after 24 weeks of gestation\n9. An active case of COVID-19 (confirmed by a positive test for COVID-19) that is not recovered (confirmed by a negative test for COVID-19) by the date of randomization\n10. Unstable pregnancy defined as meeting any of the following criteria\n\n    1. Abnormal amniotic fluid volume defined as oligohydramnios or polyhydramnios where the maximal vertical pocket (MVP) is \\\u003C 2 cm or \\> 8 cm in the third trimester, respectively\n    2. Umbilical artery Dopplers with S\u002FD ratio or resistive index (RI) \\> 97th percentile for age with or without absent or reversed end diastolic flow\n    3. Non-stress test (NST) or biophysical profile (BPP) deemed non-reassuring by treating clinician\n11. Concurrent enrollment in another study that requires either a treatment or intervention which would either alter the delivery plan or potentially influence the maternal, fetal, and neonatal outcomes of this study\n12. Traditional surrogacy, gestational surrogacy, gestational carrier, or gestational surrogate\n13. Incapable of providing informed consent\n14. Are not their own legally authorized representative.","FEMALE","18 Years",{"count":18,"type":19},300,"ESTIMATED","INTERVENTIONAL",[22],"NA","The objective of this study is to investigate the hypothesis that delivery at 35 0\u002F7- 35 6\u002F7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0\u002F7 - 38 6\u002F7 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.",[25],"Gastroschisis","RECRUITING","2026-05-22",{"date":29,"type":30},"2026-05-27","ACTUAL",{"date":32,"type":30},"2018-02-23",{"date":34,"type":19},"2029-03-31",{"name":36,"class":37},"Medical College of Wisconsin","OTHER",38,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100521698","the-influence-of-feeding-source-on-the-gut-microbiome-and-time-to-full-feeds-in-neonates-with-congenital-gastrointestinal-pathologies-100521698","NCT06072976","The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies","Inclusion Criteria:\n\n* Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.\n\nExclusion Criteria:\n\n1. Infant has already been on feeds\n2. Infants \\\u003C34 weeks gestation\n3. Parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth BUT oxy\u002Fsuboxone\u002Fmarijuana OK)\n4. Complicated gastroschisis\n5. Short gut syndrome\n6. Additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease BUT kidney disease ok)","ALL","0 Days","55 Years",{"count":49,"type":19},116,[22],"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.",[53,54,25,55,56,57],"Gastrointestinal Complication","Intestinal Obstruction","Hirschsprung Disease","Omphalocele","Midgut Volvulus","2026-04-28",{"date":60,"type":30},"2026-04-30",{"date":62,"type":30},"2023-06-09",{"date":64,"type":19},"2027-06-09",{"name":66,"class":37},"Seattle Children's Hospital",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":20,"phases":76,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":67},"100493369","fetal-repair-of-complex-gastroschisis-a-safety-and-feasibility-trial-100493369","NCT05704257","Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial","Inclusion Criteria:\n\n1. Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study\n2. Singleton pregnancy\n3. Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity)\n4. Intraabdominal bowel dilation ≥ 8 mm at 20-24 weeks GA reviewed by prenatal ultrasound\n5. Absence of significant associated anomalies\\* diagnosed on prenatal ultrasound or MRI\n6. Gestational age at the time of the procedure will be between 20 0\u002F7 weeks and 27 6\u002F7 weeks\n7. Absence of chromosomal and clinically significant abnormalities, i.e., normal karyotype and\u002For normal chromosomal microarray (CMA) by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Results by fluorescence in situ hybridization (FISH) will be accepted, if the candidate's gestation age is ≥ 22 0\u002F7 weeks. Patients declining invasive testing will be excluded\n8. The family has considered and declined the option of termination of the pregnancy at less than 24 weeks and of standard postnatal treatment\n9. The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)\n10. Parental\u002Fguardian permission (informed consent) for follow up of the child after birth\n\n    * Significant associated anomalies are defined as such anomalies that would, in and of themselves, be life limiting or life threatening. A minor anomaly, such as a small VSD or ASD not deemed to be life limiting or threatening, or a cleft lip or other such anomaly, unless part of a genetic syndrome, will not disqualify the patient.\n\nExclusion Criteria:\n\n1. Significant fetal anomaly unrelated to gastroschisis\n2. Evidence of bowel perforation (presence of intraabdominal bowel calcification on ultrasonography)\n3. Increased risk for preterm labor including short cervical length (≤ 2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth in a singleton pregnancy (other than a patient delivered for a non-repeating medical or surgical indication)\n4. Placental abnormalities (previa, abruption, accreta) known at time of enrollment\n5. Pre-pregnancy body-mass index (BMI) ≥40\n6. Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment\n7. Technical limitations precluding fetoscopic surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies\n8. Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy.\n9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment\n10. Maternal medical condition that is a contraindication to surgery or general anesthesia\n11. Low amniotic fluid volume (Amniotic Fluid Index less than 6 cm) if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion criterion\n12. Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy\n13. Inability to comply with the travel and follow-up requirements of the trial\n14. Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale (EPDS)\n15. Patients that are enrolled or have been enrolled in any another intervention study that affects the mother or fetus\n16. Maternal hypersensitivity to any of the entities associated w\u002F AlloDerm™. The use of AlloDerm™ Regenerative Tissue Matrix distributed by Allergan Aesthetics is contraindicated for patients sensitive to any of the antibiotics listed on the AlloDerm package, i.e., Gentamycin, Cefoxitin, Lincomycin, Polymyxin B and Vancomycin or Polysorbate 20",{"count":75,"type":19},10,[22],"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.",[25],[25,80],"Abdominal Wall Defect","2026-04-21",{"date":83,"type":30},"2026-04-23",{"date":85,"type":30},"2023-10-20",{"date":87,"type":19},"2029-12",{"name":89,"class":37},"Baylor College of Medicine",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":45,"minAge":46,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":20,"phases":101,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100583640","early-feeds-in-gastroschisis-100583640","NCT06878950","Early Feeds in Gastroschisis","The GAIN Study: The Gastroschisis And Early Infant Nutrition Study","GAIN","Inclusion Criteria:\n\n* Neonates with presumed simple gastroschisis\n* Born at ≥ 34 weeks' gestation\n* Hemodynamically stable\n* Consented within 48 hours after abdominal closure\n* Mothers who are ≥16 years old\n* Mothers who speak English or Spanish\n\nExclusion Criteria:\n\n* Neonates with evidence of complex gastroschisis at time of closure (any ischemic bowel, intestinal perforation, or obvious atresia with mesenteric defect)\n* Presence of any major congenital anomalies\n* Neonates who are receiving ionotropic medications\n* Neonates who are wards of the state\n* Neonates whose care is considered to be futile or those undergoing re-direction of care\n* Neonates participating in another interventional trial\n* Any patient deemed unfit for participation by study investigator(s)","1 Year",{"count":100,"type":19},20,[22],"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.",[25],[25,105],"Early feeds in Gastroschisis","2026-03-13",{"date":108,"type":30},"2026-03-17",{"date":110,"type":30},"2025-02-24",{"date":112,"type":19},"2029-02-01",{"name":114,"class":37},"University of California, Davis",2,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":126,"conditions":127,"keywords":146,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":115},"100345304","fetal-electrophysiologic-abnormalities-in-high-risk-pregnancies-associated-with-fetal-demise-100345304","NCT03775954","Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise","Fetal Electrophysiologic Abnormalities in High-risk Pregnancies Associated With Fetal Demise","Inclusion Criteria:\n\n* Current pregnancy complicated by one of the five diagnostic categories\n\n  * prior unexplained Stillbirth at\u002Fafter 20 weeks gestation\n  * fetal major congenital heart defect\n  * fetal hydrops\n  * fetal gastroschisis\n  * monochorionic twin pregnancy\n* Subject must be 18 years of age or older\n* Subject must be English speaking and must be able to read and sign the consent form in English\n* Subject must be able to recline comfortably for 1-3 hours\n* Subject must be willing to complete all three procedures (fMCG, fMCG, nECG) as per protocol, unless medically unable\n* Subject must be willing to allow us to review her and her infants prenatal, deliver, and post-natal records to verify diagnosis, and clinical findings.\n\nExclusion Criteria:\n\n* Severe claustrophobia not reduced by taking breaks, or by having the light on, or by having someone in the room with them.\n* Active labor\n* Acute illness\n* Unable to recline comfortably with a pillow for more than 1-3 hours (assuming some breaks are provided)\n* Weight over 450 lbs\n* An electric stimulation device (TENS unit, pacemaker, or nerve stimulator) that could produce electric or magnetic noise.\n\n  * Note that the Tristan 624 Magnetometer does not pose a risk to the subject's device, (since fMCG does not produce any energy or magnetism), but stimulators themselves can cause interference for our recordings. Some devices may still qualify, and discussion with study nurse may be useful if subject has a pacemaker or similar device.\n\nThe subject will have a single 2-3 hour fetal magnetocardiogram at approximately 20 and 27 weeks GA, and again, if medical condition allows, between 30 and 37 weeks GA, then her infant will have an ECG between 0 and 4 weeks of age. Subjects will be paid a nominal fee for their participation each time, as well as transportation reimbursement if \\>25 miles. For subjects traveling a long distance, the ECG may be performed locally or at home.",{"count":124,"type":19},30,"OBSERVATIONAL","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.",[128,129,130,131,25,132,133,134,135,136,137,138,139,140,141,142,143,144,145],"High Risk Pregnancy","Congenital Heart Disease","Fetal Hydrops","Twin Monochorionic Monoamniotic Placenta","Fetal Demise","Stillbirth","Fetal Arrhythmia","Long QT Syndrome","Intrauterine Fetal Death","Sudden Infant Death","Pregnancy Loss","Twin Twin Transfusion Syndrome","Birth Defect","Fetal Cardiac Anomaly","Fetal Cardiac Disorder","Fetal Death","Brugada Syndrome","Fetal Tachycardia",[147,133,148,149,150,128,151,152,153,154,155,156,157],"Fetal Magnetocardiography","Intrauterine Fetal Demise","Fetal Heart Rate Variability","Fetal Arrhythmias","Pregnancy","Fetal Anomaly","Fetal Echocardiography","Non-Stress Testing","New Technology","Birth Defects","Fetal Research","2026-03-02",{"date":160,"type":30},"2026-03-04",{"date":162,"type":30},"2018-07-01",{"date":164,"type":19},"2028-11-30",{"name":36,"class":37},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":45,"minAge":4,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":176,"conditions":177,"keywords":183,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":115},"100572329","an-exploratory-physiological-study-of-post-operative-recovery-in-surgical-neonates-and-dimethylargininearginine-levels-100572329","NCT06731855","An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels","An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels (SuNDiAL)","SuNDiAL","Inclusion Criteria:\n\n1. Infants born \\>35 weeks gestation\n2. Have a condition requiring major gastrointestinal surgery\n3. Surgery within the first 5 days (120 hours) following birth (including congenital diaphragmatic hernia who are stable enough for surgery in this time frame).\n4. Parent(s)\u002Fguardian(s) must have a comprehensive understanding of written and spoken English, sufficient to provide informed using the translation services available to the research team.\n5. Must be willing and able to provide informed consent in order to take part in the study\n\nExclusion Criteria:\n\n1. Infants who are unlikely to survive because of poor immediate postoperative condition.\n2. Infants known (or suspected to have) a diagnosis of inborn error of metabolism or serious liver dysfunction.\n3. Parent(s)\u002Fguardian(s) who are unable to give informed consent.\n4. Infants who it is not possible to obtain the minimum required residual serum samples from routine biochemical blood testing as outlined in the study schedule","5 Days",{"count":124,"type":19},"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.\n\nThe 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.\n\nNeonates 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.\n\nArginine 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.\n\nSerums 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.\n\nThe 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.",[25,178,179,180,181,182],"Congenital Diaphragmatic Hernia","Duodenal Atresia","Oesophageal Atresia With Tracheo-Oesophageal Fistula","Oesophageal Atresia","Exomphalos",[184,185,186,187,188,189,190],"Neonatal","Abdominal Surgery","Asymmetric Dimethylarginine","ADMA","Arginine","Recovery","Neonate","2025-09-24",{"date":193,"type":30},"2025-09-29",{"date":195,"type":30},"2024-02-05",{"date":197,"type":19},"2026-02",{"name":199,"class":37},"Liverpool Women's NHS Foundation Trust"]