Direct Peritoneal Resuscitation in Gastroschisis
Condition: Gastroschisis
MeSH terms: Gastroschisis
Intervention: SoC Staged Silo Closure; Peritoneal Dialysis Solution/Dextrose 1.5%
Intervention description: Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days.; Serial reductions will be performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain will be securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe will then be connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed (generally 3-5 days), but not to exceed 7 days maximum. Fluid will be warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion will be 10 mL/kg of dialysate. If tolerated, each subsequent infusion will be increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate will dwell for 1 hour after instillation of fluid. Any excess fluid will then be removed via JP drain.
Intervention MeSH terms: Dialysis Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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 only. All subjects will be placed in a silo shortly after birth and within 2 hours of admission to the NICU and subsequently serially reduced in silo with umbilical tape until the bowel contents are at the level of fascia and deemed suitable for closure.
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 0 Hours
Maximum age: 12 Hours
Healthy volunteers: No
Keywords: Neonate

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Gastroschisis

          -  Male or Female, any ethnicity

          -  Neonates [0-27 days as defined by the Age Classification in the ICH E-11]

        Exclusion Criteria:

          -  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)