Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis (NEST)
This study is currently recruiting participants.
Verified January 2013 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01029353
First received: December 9, 2009
Last updated: January 14, 2013
Last verified: January 2013
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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 |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Death or neurodevelopmental impairment [ Time Frame: Up to 18-22 months corrected age ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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: | September 2015 |
| Estimated Primary Completion Date: | December 2013 (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 |
Criteria
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 Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029353
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Contacts
| Contact: Martin L. Blakely, MD | 615-936-1050 | martin.blakely@vanderbilt.edu |
| Contact: Rosemary D. Higgins, MD | 301-435-7909 | higginsr@mail.nih.gov |
Hide Study LocationsLocations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Waldemar A. Carlo, MD 205-934-4680 wcarlo@peds.uab.edu | |
| Contact: Monica V. Collins, RN BSN (205) 934-5771 mcollins@peds.uab.edu | |
| Principal Investigator: Waldemar A. Carlo, MD | |
| Sub-Investigator: Carroll M. Harmon, MD | |
| Sub-Investigator: Reed Dimmitt, MD | |
| United States, California | |
| University of California - Los Angeles | Recruiting |
| Los Angeles, California, United States, 90025 | |
| Contact: Uday Devaskar, MD 310-825-9357 udevaskar@mednet.ucla.edu | |
| Contact: Teresa Chanlaw, BS (310) 794-4972 tchanlaw@mednet.ucla.edu | |
| Principal Investigator: Uday Devaskar, MD | |
| Sub-Investigator: James Dunn, MD, PhD | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Krisa P. Van Meurs, MD 650-723-5711 vanmeurs@leland.stanford.edu | |
| Contact: M. Bethany Ball, BS CCRC (650) 725-8342 mbball@stanford.edu | |
| Principal Investigator: Krisa P. Van Meurs, MD | |
| Sub-Investigator: Karl Sylvester, MD | |
| United States, Connecticut | |
| Yale University | Active, not recruiting |
| New Haven, Connecticut, United States, 06504 | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Barbara J. Stoll, MD 404-727-5740 barbara_stoll@oz.ped.emory.edu | |
| Contact: Ellen Hale, RN BS (404) 616-4218 ellen_hale@oz.ped.emory.edu | |
| Principal Investigator: Barbara J. Stoll, MD | |
| Sub-Investigator: Richard Ricketts, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Brenda B. Poindexter, MD MS 317-274-3592 bpoindex@iupui.edu | |
| Contact: Leslie D. Wilson, RN BSN (317) 274-8255 ldw@iupui.edu | |
| Principal Investigator: Brenda B. Poindexter, MD MS | |
| Sub-Investigator: Scott Engum, MD | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Edward F. Bell, MD 319-356-4006 edward-bell@uiowa.edu | |
| Contact: Karen J. Johnson, RN BSN (319) 356-2924 karen-johnson@uiowa.edu | |
| Principal Investigator: Edward F. Bell, MD | |
| Sub-Investigator: Joel Shilyansky, MD | |
| United States, Massachusetts | |
| Tufts Medical Center | Active, not recruiting |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Seetha Shankaran, MD 313-580-4452 sshankar@med.wayne.edu | |
| Contact: Rebecca Bara, RN BSN (313) 745-1436 rbara@med.wayne.edu | |
| Principal Investigator: Seetha Shankaran, MD | |
| Sub-Investigator: Christina M. Shanti, MD | |
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: William Truog, MD 816-234-3592 wtruog@cmh.edu | |
| Contact: Cheri Gauldin, BSN (816) 234-3920 cagauldin@cmh.edu | |
| Principal Investigator: William Truog, MD | |
| Sub-Investigator: George Holcomb, MD | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Kristi L. Watterberg, MD 505-272-3967 kwatterberg@salud.unm.edu | |
| Contact: Conra Backstrom Lacy, RN (505) 272-0367 cbackstrom@salud.unm.edu | |
| Principal Investigator: Kristi L. Watterberg, MD | |
| Sub-Investigator: David Lemon, MD | |
| Sub-Investigator: Cynthia Reyes, MD | |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Carl T D'Angio, MD 585-273-4911 carl_dangio@urmc.rochester.edu | |
| Principal Investigator: Carl T D'Angio, MD | |
| Sub-Investigator: Walter Pegoli, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Ronald N. Goldberg, MD 919-681-6025 goldb008@mc.duke.edu | |
| Contact: Kimberly A. Fisher 919-681-4913 kimberley.fisher@duke.edu | |
| Principal Investigator: Ronald N. Goldberg, MD | |
| Sub-Investigator: Henry Rice, MD | |
| RTI International | Active, not recruiting |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Kurt Schibler, MD 513-636-3972 kurt.schibler@cchmc.org | |
| Contact: Cathy Grisby, BSN CCRC (513) 558-4953 grisbyca@email.uc.edu | |
| Principal Investigator: Kurt Schibler, MD | |
| Sub-Investigator: Rebeccah Brown, MD | |
| Case Western Reserve University | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Michele C. Walsh, MD MS 216-844-3759 mcw3@cwru.edu | |
| Contact: Nancy S. Newman, BA RN (216) 368-3084 nxs5@cwru.edu | |
| Principal Investigator: Michele C. Walsh, MD MS | |
| Sub-Investigator: Walter Chwals, MD | |
| Research Institute at Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Leif Nelin, MD 614-722-3030 Leif.Nelin@nationwidechildrens.org | |
| Contact: Christine Fortney, MS, RN 614-722-6489 christine.fortney@nationwidechildrens.org | |
| Principal Investigator: Leif Nelin, MD | |
| Sub-Investigator: Gail E Besner, MD | |
| United States, Pennsylvania | |
| Univeristy of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Barbara Schmidt, MD 215-662-3228 barbara.schmidt@uphs.upenn.edu | |
| Contact: Aasma Chaudhary, BS 215-615-5442 aasma.chaudhary@uphs.upenn.edu | |
| Principal Investigator: Barbara Schmidt, MD | |
| Sub-Investigator: Alan Flake, MD | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Abbot R. Laptook, MD 401-274-1122 alaptook@WIHRI.org | |
| Contact: Angelita Hensman (401) 274-1122 ahensman@wihri.org | |
| Principal Investigator: Abbot R. Laptook, MD | |
| Sub-Investigator: Arlett Kurkchubashe, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Lina Chalak, MD 214-648-0364 lina.chalak@utsouthwestern.edu | |
| Contact: Diana M. Vasil, RNC-NIC (214) 648-3789 Diana.Vasil@utsouthwestern.edu | |
| Principal Investigator: Pablo J. Sanchez, MD | |
| Sub-Investigator: Nilda Garcia, MD | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Kathleen A. Kennedy, MD MPH 713-500-6708 Kathleen.A.Kennedy@uth.tmc.edu | |
| Contact: Georgia E. McDavid, RN (713) 500-5734 Georgia.E.McDavid@uth.tmc.edu | |
| Principal Investigator: Kathleen A. Kennedy, MD MPH | |
| Sub-Investigator: Kevin Lally, MD | |
| United States, Utah | |
| University of Utah | Active, not recruiting |
| Salt Lake City, Utah, United States, 84108 | |
Sponsors and Collaborators
Investigators
| 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: | January 14, 2013 |
| 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 Intestinal Perforation Enterocolitis, Necrotizing Body Weight |
Signs and Symptoms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013