Gastroschisis
Conditions
Keywords
gastroschisis, silo, primary closure
Brief summary
The objective of this study is to scientifically evaluate two different closure strategies for gastroschisis to determine if there is a difference in the two approaches.
Detailed description
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 length of hospitalization. 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.
Interventions
PROCEDUREsilo for gastroschisis
silo placed around abdominal contents in gastroschisis patients
PROCEDUREPrimary closure of gastroschisis
Primary closure of gastroschisis, if possible
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Minutes to 2 Days
Healthy volunteers
No
Inclusion criteria
* Infants with gastroschisis
Exclusion criteria
* Born prior to 34 weeks estimated gestational age * Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery. * Inability to get parental permission before treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospitalization | 1-6 weeks | The length of time required for meeting discharge criteria |
Countries
United States
Outcome results
None listed