Direct Peritoneal Resuscitation in Gastroschisis

• Status: Terminated
• Trial end date: 2020-10-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Dialysis Solutions

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)