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Gastroschisis clinical trials

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NCT ID: NCT03350022 Completed - Clinical trials for Short Bowel Syndrome

Sham Feeding Post-operative Infants

Start date: January 10, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03334578 Withdrawn - Gastroschisis Clinical Trials

The Use of Gastrografin to Help Alleviate Bowel Obstruction in Gastroschisis Patients.

Start date: August 3, 2018
Phase: Phase 4
Study type: Interventional

This study will investigate the use of a drug called Gastrografin to aid in bowel mobility for paediatric patients who have undergone gastroschisis surgery. Gastroschisis is an abdominal wall birth defect where the bowel protrudes through a small opening beside the umbilicus. In these patients, the bowel is often less mobile due to its exposure outside of the body during fetal development. It is common for the bowel to be swollen and matted, which decreases motility and makes it increasingly difficult for the baby to have normal bowel function. Administering Gastrografin facilitates the entry of water into the intestines and bowel, which is thought to aid in bowel function and motility. This study will compare gastroschisis patients who received Gastrografin to gastroschisis patients collected as part of an ongoing observational study at our centre who did not receive Gastrografin.

NCT ID: NCT03205553 Terminated - Gastroschisis Clinical Trials

Direct Peritoneal Resuscitation in Gastroschisis

Start date: February 1, 2018
Phase: Phase 1
Study type: Interventional

This is a prospective, double-arm study designed to evaluate the tolerability of direct peritoneal resuscitation (DPR) in neonates with gastroschisis. The experimental arm (DPR group) will receive adjuvant DPR with standard treatment for gastroschisis (staged silo closure). The control arm (SoC group) will receive standard treatment for gastroschisis without DPR. The Research Team will prospectively enroll all neonates with the diagnosis of gastroschisis presenting to ACH within 12 hours after birth for whom consent is signed by the parent(s)/legally authorized representative (LAR). The Research Team anticipates enrolling 40 subjects at Arkansas Children's Hospital. All subjects that have their abdominal wall defect closed will be defined as having completed active participation in the study.

NCT ID: NCT03185637 Completed - Inguinal Hernia Clinical Trials

Children's Surgery in Sub-Saharan Africa

PaedSurgAfrica
Start date: October 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

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.

NCT ID: NCT02774746 Recruiting - Gastroschisis Clinical Trials

Gastroschisis Outcomes of Delivery (GOOD) Study

Start date: February 23, 2018
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT02575846 Completed - Gastroschisis Clinical Trials

Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair

Start date: November 26, 2015
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02370251 Completed - Clinical trials for Short Bowel Syndrome

Compassionate Use of Omegaven in Children

Start date: June 2015
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT02098915 Terminated - Gastroschisis Clinical Trials

Metoclopramide Pilot Trial

Start date: March 2014
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01884324 Terminated - Gastroschisis Clinical Trials

Randomized Clinical Trial of Early Delivery in Fetal Gastroschisis vs. Routine Care

Start date: June 2013
Phase: N/A
Study type: Interventional

Primary objective: to test the hypothesis that elective early delivery will protect the fetal bowel from the deleterious intrauterine factors late in the pregnancy and will be associated with improved neonatal outcomes. Secondary objective: to introduce a standardized diagnostic, monitoring, and postnatal surgical management of infants with gastroschisis.

NCT ID: NCT01506531 Completed - Gastroschisis Clinical Trials

Silo Versus Primary Closure for Gastroschisis

Start date: August 2011
Phase: N/A
Study type: Interventional

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.