Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free survival at 18-22 months corrected age.
Official Title
A Multi-center Randomized Trial of Laparotomy vs. Drainage as the Initial Surgical Therapy for ELBW Infants With Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP): Outcomes at 18-22 Months Adjusted Age
Eligibility Criteria
- * Infants born at ≤1,000 g birth weight* Infant is ≤8 0/7 weeks of age at the time of eligibility assessment* Pediatric surgeon decision to perform surgery for suspected NEC or IP* Subject is at a center able to perform both laparotomy and drainage
- * Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations* Congenital infection* Prior laparotomy or peritoneal drain placement* Prior NEC or IP* Infant for whom full support is not being provided* Follow-up unlikely
Investigator(s)
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Contact
M. Bethany Ball
6507258342
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