Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis (NEST)
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Purpose
This trial 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.
| Condition | Intervention |
|---|---|
|
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Enterocolitis, Necrotizing Intestinal Perforation |
Procedure: Laparotomy Procedure: Drainage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Death or neurodevelopmental impairment [ Time Frame: Up to 18-22 months corrected age ] [ Designated as safety issue: Yes ]
- Surgical complications [ Time Frame: Up to 18-22 months corrected age ] [ Designated as safety issue: Yes ]
- Number of surgical procedures [ Time Frame: Up to 18-22 months corrected age ] [ Designated as safety issue: Yes ]
- Sepsis episodes [ Time Frame: Up to 18-22 months corrected age ] [ Designated as safety issue: Yes ]
- Duration of parenteral nutrition [ Time Frame: Up to 18-22 months corrected age ] [ Designated as safety issue: No ]
- Parenteral nutrition associated cholestasis [ Time Frame: Up to 18-22 months corrected age ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
- Rehospitalizations [ Time Frame: Up to 18-22 months corrected age ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Laparotomy |
Procedure: Laparotomy
Initial laparotomy will be performed. Standard procedures will be used, including inspection of the bowel with removal of diseased areas, creation of stoma(s), and other procedures deemed indicated by the surgeon.
|
| Active Comparator: Peritoneal drain placement |
Procedure: Drainage
Initial drainage will involve placing a Penrose drain in the abdomen.
Other Name: Peritoneal drain
|
Detailed Description:
Necrotizing enterocolitis (NEC) is a condition, generally affecting premature infants, in which the intestines become ischemic (lack oxygen and/or blood flow). NEC occurs in up to 5-15% of extremely low birth weight (ELBW) infants. Isolated or focal intestinal perforation (IP) is a less common condition, affecting an estimated 4% of ELBWs, in which a hole develops in the intestines leaking fluid into the abdominal cavity. Outcome for infants with NEC and/or IP is poor: 49% die and half of the surviving infants are neurodevelopmentally impaired.
Surgical options for NEC and IP include two possible procedures: peritoneal drainage, in which a tube is placed in the abdominal cavity through a small incision for fluid to drain out; or laparotomy, in which an incision is made in the abdomen and necrotic intestine is removed. Drainage may be followed by a laparotomy.
The Neonatal Research Network's observational study of 156 ELBW infants with NEC or IP (Pediatrics. 2006 Apr; 117(4): e680-7) showed comparable outcomes for the two procedures before hospital discharge, but suggested an advantage of laparotomy over drainage at 18-22 months corrected age with lower rates of death or neurodevelopmental impairment. However, the infants that underwent laparotomy were more mature; infants with drains were smaller and more premature. We hypothesize that initial laparotomy may improve an infant's long-term neurodevelopmental outcome, potentially by reducing the maximum severity or duration of inflammation.
This study is a randomized controlled trial to compare the effectiveness of laparotomy versus drainage for treating NEC or IP in extremely low birth weight infants. Target enrollment is 300 infants diagnosed with NEC or IP for randomization to receive initially either a laparotomy or drainage. Subsequent laparotomies may be performed on infants in either group, if their condition continues to deteriorate. Surviving infants will return for a follow-up assessment at 18-22 months corrected age.
This trial uses a comprehensive cohort design that adds to the conventional randomized trial design, as a secondary specific aim. In addition to collecting detailed information on the randomized infants, we will also collect information on non-randomized infants with NEC/IP who are officially enrolled into a preference cohort.
Eligibility| Ages Eligible for Study: | up to 8 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion 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
Exclusion Criteria:
- 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01029353
| Contact: Martin L. Blakely, MD | 615-936-7211 | ||
| Contact: Rosemary D. Higgins, MD | 301-496-5575 |
Show 22 Study Locations
| Principal Investigator: | Abbot R. Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island | |
| Principal Investigator: | Michele C. Walsh, MD MS | Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Principal Investigator: | Ronald N. Goldberg, MD | Duke University | |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University | |
| Principal Investigator: | Brenda B. Poindexter, MD MS | Indiana University | |
| Principal Investigator: | Abhik Das, PhD | RTI International | |
| Principal Investigator: | Krisa P. Van Meurs, MD | Stanford University | |
| Principal Investigator: | Ivan D. Frantz III, MD | Tufts Medical Center | |
| Principal Investigator: | Kurt Schibler, MD | Cincinnati Children's Medical Center | |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham | |
| Principal Investigator: | Edward F. Bell, MD | University of Iowa | |
| Principal Investigator: | Kristi L. Watterberg, MD | University of New Mexico | |
| Principal Investigator: | Pablo J. Sanchez, MD | University of Texas Southwestern Medical Center at Dallas | |
| Principal Investigator: | Kathleen A. Kennedy, MD MPH | The University of Texas Health Science Center, Houston | |
| Principal Investigator: | Roger G. Faix, MD | University of Utah | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University | |
| Study Director: | Martin K. Blakely, MD | University of Tennessee Health Science Center | |
| Principal Investigator: | William Truog, MD | Children's Mercy Hospital-Kansas City, MO | |
| Principal Investigator: | Barbara Schmidt, MD, MSc | Univeristy of Pennsylvania | |
| Principal Investigator: | Carl D'Angio, MD | University of Rochester | |
| Principal Investigator: | Uday Devaskar, MD | University of Carlifornia - Los Angeles | |
| Principal Investigator: | Leif Nelin, MD | Research Institute at Nationwide Children's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT01029353 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0039, U10HD021364, U10HD021373, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880, U10HD027904, U10HD034216, U10HD036790, U10HD040492, U10HD040689, U10HD053089, U10HD053109, U10HD053119, U10HD053124, UL1RR024139, UL1RR025744, UL1RR025764, UL1RR025777, M01RR008084, UL1RR024979, U10HD068284, U10HD068278, U10HD068270, U10HD068263, U10HD068244 |
| Study First Received: | December 9, 2009 |
| Last Updated: | October 28, 2014 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
NICHD Neonatal Research Network Very Low Birth Weight (VLBW) Extremely Low Birth Weight (ELBW) Prematurity |
Laparotomy Drainage Isolated intestinal perforation Focal intestinal perforation |
Additional relevant MeSH terms:
|
Birth Weight Enterocolitis Enterocolitis, Necrotizing Intestinal Perforation Body Weight |
Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on March 03, 2015