Direct Peritoneal Resuscitation in Gastroschisis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Days to Full Enteral Feeds
研究概览
简要总结
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.
详细描述
Gastroschisis is a clinical condition characterized by a defect in the normal development of the abdominal wall. The defect is present to the right of the umbilicus leading to in utero bowel evisceration and exposure to amniotic fluid. After birth and prior to operation, the usual treatment consists of covering the bowel with an impermeable plastic bag to prevent additional fluid losses and bowel desiccation. Subsequent operative intervention occurs either in the operating room or in the neonatal intensive care unit. Two surgical options include primary closure of the abdomen or placement of a silastic silo followed by subsequent closure several days later as a staged procedure. The main reason the abdominal wall is not closed initially is due to fear of abdominal compartment syndrome, a condition caused by high intra-abdominal pressures leading to respiratory and circulatory compromise. The key points of the initial surgery involve examining the intestine for any signs of atresia, bowel compromise, and either placement of the bowels back into the abdomen or a spring-loaded silo.
Arkansas Children's Hospital (ACH) has one of the highest rates of gastroschisis patients in the country and therefore has extensive experience managing these patients. It is not currently known why ACH has one of the highest rates of gastroschisis, but it has been postulated it may be due to some factor more common in low socioeconomic status population. ACH is the only pediatric hospital in the state of Arkansas. Quarterly, reviews of the Children's Hospital National Database (CHND) are performed to track the institutions progress in comparison to national trends. ACH's current surgical practice is to place nearly all patients in a silastic silo for staged reduction. Rarely are patients with gastroschisis treated with primary surgical closure at ACH. Serial reductions are performed and once the abdominal contents are at the level of the fascia the abdomen is closed in the operating room. Previous data indicates an average of five days from birth for final reduction and closure. After closure, there can be significant intestinal dysmotility with a prolonged ileus and a delayed return of bowel function. Generally, those with uncomplicated gastroschisis spend approximately 26 days in the neonatal intensive care unit before discharge home.
From historical CHND data, it is known that patients with simple gastroschisis have an average length of stay of 29 days, average of 5 days until abdominal wall closure, average of 7 days until start of enteral feeding after abdominal wall closure and average of 10 days until meeting 100 kcal per kg per day enteral feeds.
Direct Peritoneal Resuscitation The University of Louisville has been at the forefront of research for Direct Peritoneal Resuscitation (DPR). This technique uses clinically available peritoneal dialysis solution instilled into the abdomen with an initial bolus of 500 mL followed by a rate of 1.5 mL/kg/h in adults undergoing closure of the abdominal wall after traumatic injuries.
The aforementioned lab has also studied DPR in a rat model of hemorrhagic shock. The model has shown decreased mortality and increased intestinal and liver blood flow [2-5]. The group further investigated the use of DPR in a rat model of Necrotizing Enterocolitis (NEC) and discovered that 1.5% and 2.5% peritoneal dialysis solutions used as DPR improved intestinal blood flow, and with the 1.5% solution, there was less hyperglycemia than in the group treated with the 2.5% solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Hours 至 12 Hours(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Gastroschisis
- •Male or Female, any ethnicity
- •Neonates [0-27 days as defined by the Age Classification in the ICH E-11]
排除标准
- •Primary gastroschisis repair
- •Vanishing gastroschisis
- •Encapsulating peritoneal sclerosis
- •Infants < 2 kg and < 34 weeks gestation
- •Infants > 12 hours at enrollment
- •Severe hypotension, defined as either:
- •Mean arterial blood pressure (MAP) < gestational age in weeks, or
- •Systolic blood pressure (BP) < 45 or diastolic BP < 20
- •Severe Hypertension defined as Systolic BP > 90 or diastolic > 60
- •Culture-positive sepsis
- •Known or strongly suspected inborn errors of metabolism
- •Significant cardiac disorders, including cyanotic congenital heart disease, ductal-dependent congenital heart disease, and critical congenital heart disease (lesions requiring surgery or catheter-based intervention in the first year of life)
- •Respiratory failure, defined as any requirement of positive pressure ventilation at the time of enrollment, or FiO2 > 50%
- •Any other condition, that, in the opinion of the investigator, might interfere with the safe conduct of the study or place the subject at increased risk
- •Lactic acidosis with at least one or more of the following:
- •Characterized by increased blood lactate levels (> 5 mmol/L) on two occasions at least 6 hours apart
- •Severe metabolic acidosis with an arterial pH ≤ 7.0
- •Bicarbonate < 14 or CO2 < 12
- •Base excess of > -10 mEq/L
- •Neonatal Acute Renal Failure, defined as serum creatinine > 2.0 mg/dL with anuria in the first 12 hours of life
- •Neonatal Acute Hepatic Failure, defined as INR > 3
- •Liver function test abnormalities defined as AST > 200, ALT > 200, GGT > 100
- •Electrolyte abnormalities, defined as:
- •Sodium < 130 or > 150 mEq/L
- •Potassium < 3.0 or > 6.5 mEq/L
- •Hyperglycemia (> 150 mg/dL) or hypoglycemia (< 40 mg/dL)
研究组 & 干预措施
Standard of Care (SoC) Treatment Group
The SoC group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice and subsequently serially reduced in silo (staged silo reduction) until the bowel contents are at the level of fascia and deemed suitable for closure. These subjects will have no change in current clinical management by the neonatologists or pediatric surgeons.
干预措施: SoC Staged Silo Closure (Procedure)
Direct Peritoneal Resuscitation (DPR) Treatment Group
The DPR group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects will be treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement), which is usually four to five days.
干预措施: SoC Staged Silo Closure (Procedure)
Direct Peritoneal Resuscitation (DPR) Treatment Group
The DPR group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects will be treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement), which is usually four to five days.
干预措施: Peritoneal Dialysis Solution/Dextrose 1.5% (Drug)
结局指标
主要结局
Days to Full Enteral Feeds
时间窗: Up to Hospital Discharge (average 30 days)
To demonstrate that subjects treated with DPR will have a more benign hospital course as measured by time to full enteral feeds. The primary outcome measure will be time to full feeds of 100 kcal/kg/day. This is assessed once daily on morning rounds by the neonatology team.
次要结局
- Days to Abdominal Wall Closure(Up to 7 days)
- Days on Total Parental Nutrition (TPN)(Until Day of Discharge, an average of 29 days)
- Days to Intestinal Motility(Up to 3 weeks post-closure)
- Number of Days in the Hospital(Until Day of Discharge, an average of 40 days)
