Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis



Status:Active, not recruiting
Conditions:Colitis, Women's Studies, Gastrointestinal
Therapuetic Areas:Gastroenterology, Reproductive
Healthy:No
Age Range:Any
Updated:2/21/2019
Start Date:January 2010
End Date:May 2019

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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

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.

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.

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
We found this trial at
22
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Barbara J. Stoll, MD
Phone: 404-727-2456
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Waldemar A. Carlo, MD
Phone: 205-934-4680
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Myra Wyckoff, MD
Phone: 214-648-0364
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Seetha Shankaran, MD
Phone: 313-745-1436
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Ronald N. Goldberg, MD
Phone: 919-681-6024
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Kathleen A. Kennedy, MD MPH
Phone: 713-500-6708
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Brenda B. Poindexter, MD MS
Phone: 317-274-4768
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Edward F. Bell, MD
Phone: 319-356-4006
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: William Truog, MD
Phone: 816-234-3592
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Uday Devaskar, MD
Phone: 310-825-9314
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Providence, Rhode Island 02905
Principal Investigator: Abbot R. Laptook, MD
Phone: 401-274-1122
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Carl T D'Angio, MD
Phone: 585-273-4911
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Brad Yoder, MD
University of Utah Research is a major component in the life of the U benefiting...
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Kristi L. Watterberg, MD
Phone: 505-272-8609
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Cincinnati, Ohio 45267
Principal Investigator: Brenda Poindexter, MD, MS
Phone: 513-636-3972
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Michele C. Walsh, MD MS
Phone: 216-844-3387
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Columbus, Ohio 43205
Principal Investigator: Leif Nelin, MD
Phone: 614-355-6724
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Palo Alto, California 94304
Principal Investigator: Krisa P. Van Meurs, MD
Phone: 650-723-5711
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Philadelphia, Pennsylvania 19104
Principal Investigator: Barbara Schmidt, MD
Phone: 215-662-3228
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