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Gastroschisis clinical trials

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NCT ID: NCT01469208 Recruiting - Gastroschisis Clinical Trials

Music Therapy: An Adjunct To Gastroschisis Infants' Care

MAGIC
Start date: October 2011
Phase: N/A
Study type: Observational

The investigators hope to determine if music therapy will have beneficial effects on physiologic parameters, behavioral states, and pain scale evaluations in infants with gastroschisis defects and if music therapy promotes parental/caregiver relaxation and demonstrates to the parent/caregiver that music is an effective tool to calm and soothe their infant at risk for chronic gastrointestinal discomfort. Babies will be enrolled during the perinatal period, with therapy to begin after surgical repair of the gastroschisis defect and when the neonatologist deems the baby stable enough for music therapy intervention. Enrolled subjects may receive up to 3 music therapy sessions/week and these sessions may continue until discharge. There is no follow up after discharge. Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include: 1. Pre music therapy behavior state will be assessed using CRIES scale and recorded. 2. Five minutes of baseline vital signs will be recorded. 3. Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and lap harp to perform live lullaby tupe music with or with out vocals. Decibel levels will be maintained at 65-75dB. Session will stop if infant shows any signs of distress/agitation. Vital signs will be collected every 1-4 minutes during music session. 4. After session behavior state using CRIES scale will be recorded. 5. Family/caregiver will be given a questionnaire to fill out. 6. 30 min of quiet will start. 7. At the end of quiet time, behavior state and vital signs will be recorded for the last time.

NCT ID: NCT01316510 Completed - Gastroschisis Clinical Trials

Probiotics in Infants With Gastroschisis

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

Infants born with gastroschisis usually require surgery shortly after birth. After surgery the intestine is often unable to digest human milk or formula for weeks or months. During this time the baby has to remain in the hospital to receive special nutrition through an IV. How bacteria colonize the intestine in these babies is unknown. Probiotics are bacteria that appear to have beneficial effects on digestion. This study will test whether giving probiotic bacteria to babies after surgery for gastroschisis will change the bacteria in the intestine to be more like those of a healthy breast-fed baby.

NCT ID: NCT01094587 Terminated - Gastroschisis Clinical Trials

Sutureless vs Sutured Gastroschisis Closure

Start date: November 2009
Phase: N/A
Study type: Interventional

This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.

NCT ID: NCT01062815 Terminated - Prematurity Clinical Trials

Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants

Start date: February 2009
Phase: N/A
Study type: Interventional

Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to tolerate enteral feeds such as Short Bowel Syndrome, Chronic Intestinal Pseudoobstruction, Microvillus Inclusion Disease, Crohn's disease, multi-organ failure and prematurity. Parenteral Nutrition-Associated Liver Disease (PNALD) encompasses a spectrum of disease including cholestasis, hepatitis, steatosis and gallbladder sludge/stones which may progress to liver cirrhosis and even failure. There is a direct correlation between duration of parenteral nutrition and development of cholestasis in infants. There is evidence in animals and humans that cycling of parental nutrition, defined as infusing nutrients over a time period shorter than 24 hours, reduces cholestasis. There is also data that premature infants with gestational age (GA) < 32 weeks and birth weight <1500g, as well as infants with congenital anomalies of the gastrointestinal tract, are among those at highest risk of developing Parenteral Nutrition-Associated Cholestasis (PNAC). We therefore hypothesize that infants with gestational age (GA) <32 weeks and birth weight (BW) between <1500g, or with congenital anomaly of the gastrointestinal tract regardless of GA or BW, receiving PN over a period of 20 hours will have a decrease severity of PNAC, demonstrated by a lower peak direct bilirubin, compared to a similar control population receiving standard 24 hour infusion.

NCT ID: NCT00539292 Completed - Gastroschisis Clinical Trials

Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis

Start date: September 2005
Phase: Phase 2
Study type: Interventional

This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS) to treat infants with gastroschisis will result in improved outcomes, faster recovery times and fewer post-surgical complications than the standard selective use of the silo.

NCT ID: NCT00404690 Terminated - Gastroschisis Clinical Trials

Bedside Silo Versus Operative Closure for Gastroschisis

Start date: October 2006
Phase: N/A
Study type: Interventional

The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay. The primary outcome variable between the two techniques will be determined from this study that can then be used to develop a definitive study. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.

NCT ID: NCT00127946 Active, not recruiting - Gastroschisis Clinical Trials

Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

AMNIOECHANGE
Start date: November 2005
Phase: Phase 3
Study type: Interventional

Hypothesis: Gastroschisis is a localised disruption of the abdominal layer. It occurs early in gestation, and the bowel is therefore bathing in the amniotic fluid and can be constricted at the level of the abdominal hole. The bowel is therefore submitted to different injuries partly attributable to the contact with amniotic fluid contaminated by digestive compounds and inducing an inflammatory reaction. Experimental studies on animal models and preliminary data in humans indicate that changing regularly the amniotic fluid (i.e. AMNIOECHANGE) would improve the outcome of theses fetuses and then neonates.