Silo Study Summary

A Multi-Center, Prospective Randomized Trial of Routine Use of a Silastic Spring-loaded Silo for Infants with Gastroschisis
Jacob Langer, MD Principal Investigator

  1. Description of Study
    Babies involved in this study will be randomly assigned to one of two groups using a sealed envelope. Infants in the first group (Primary Closure) will be taken to the operating room, the bowel reduced, and the abdomen closed - if possible. If this is not possible, as determined by the operating surgeon, a spring-loaded silo will be placed. Babies in the second group (Primary Silo) will have the spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Intubation will not be routinely used, and sedation will only be used if it is felt to be necessary by the surgeon.

    In all babies who have a silo placed, whether in the Primary Closure or Primary Silo group, reduction of the eviscerated bowel will be accomplished by the daily application of gentle pressure, followed by placing a clip across the silo in order to keep the reduced bowel in the abdomen. When the bowel has been completely reduced, the baby will be taken to the operating room to have the silo removed and the abdomen closed under general anesthesia.

    Data will be collected daily during the initial hospitalization of the infant, and then at the time of each routine post-operative visit during the first year of life.
  2. Subject Population
    All neonates presenting with gastroschisis will be eligible for this study. Exclusion criteria are as follows:
    1. Birth weight < 1500 gms or gestational age < 34 weeks
    2. Major associated anomalies (congenital heart disease, hydrocephalus, or other CNS malformation)
    3. Presence of IVH
    4. Parental refusal for randomization
    5. Abdominal wall defect which is too small for a silo and/or obvious intestinal necrosis
  3. Data Collection
    • Intragastric pressure at the time of definitive closure
    • Usual bloodwork preoperatively and postoperatively for surgical neonate
    • Serum lactate level preop and 2 hours postop on day of definitive closure, then daily for three days
    • Urine output for 5 days after definitive closure
    • Days on ventilator
    • Days on TPN
    • Days to full enteral feeds
    • Hospital stay
    • In-hospital complications such as NEC, sepsis, etc
    • Post-discharge weight and height percentile, and complications

Contact Information:
Jacob Langer, MD
Principal Investigator
Hospital for Sick Children
Phone: (416) 813-6405
Email: [email protected]

Aimee Pastor, RN BScN MN
Clinical Nurse Research Coordinator
Hospital for Sick Children
Phone: (416) 813-6542
Email: [email protected]