Observational Study of Surgical Treatment of Necrotizing Enterocolotis (NEC Surgery)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01223261
First received: October 14, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP preoperatively and the importance of this distinction on outcome measures; and 3) to evaluate the association between extent of intestinal disease determined at operation and outcome measures. All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.


Condition
Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Enterocolitis, Necrotizing
Intestinal Perforation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Surgical Treatment of Necrotizing Enterocolotis or Isolated Intestinal Perforation

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:
  • Feasibility of conducting a randomized trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Ability to enroll infants in a 1-year period


Secondary Outcome Measures:
  • Document variation in current surgical practices [ Time Frame: Until hospital discharge or 120 days of life ] [ Designated as safety issue: No ]
  • Prevalence of infants who would qualify for the study [ Time Frame: Until hospital discharge or 120 days of life ] [ Designated as safety issue: No ]
  • Frequency of postoperative complications [ Time Frame: Until hospital discharge or 120 days of life ] [ Designated as safety issue: Yes ]
  • Neurodevelopmental impairment [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: Yes ]

Enrollment: 156
Study Start Date: March 2001
Study Completion Date: March 2004
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
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 abdomin. The outcomes for infants with NEC or IP are 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 diseased intestine is removed. Infants treated with an initial drainage sometimes go on to need a laparotomy. Most surgeons now believe that a diagnosis of the intestinal perforation (IP) may actually be either true NEC or a different and distinct pathology, termed isolated intestinal perforation. The ability to distinguish these 2 conditions preoperatively, based on perinatal characteristics, physical examination findings, and findings on abdominal plain film imaging, remains unknown. If these 2 entities can be distinguished preoperatively, the intervention chosen and outcomes may be different. From the two available surgical options, tt is not known whether initial laparotomy or peritoneal drain placement is more effective for either NEC or IP.

This study was a prospective, multicenter observational study to describe the surgical outcomes (mortality, post-operative intestinal stricture, intra-abdominal abscess formation, etc.) in ELBW infants with either NEC or IP who underwent initial laparotomy or peritoneal drainage. We also evaluated the ability of surgeons to distinguish NEC and IP pre-operatively and the relevance of this distinction on outcome. Finally, an analysis of the impact of extent of intestinal involvement with NEC on outcome measures is reported.

All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications.

Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.

  Eligibility

Ages Eligible for Study:   up to 6 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Extremely Low Birth Weight (ELBW) infants (those with birth weights <1000 g) born at participating NRN Centers diagnosed by a pediatric surgeon and neonatologist as having either necrotizing enterocolitis (NEC) or intestinal perforation (IP) requiring surgical intervention.

Criteria

Inclusion Criteria:

  • Infants born 401-1,000 grams at birth enrolled in the NRN Generic Database
  • Sage III NEC or isolated intestinal perforation
  • Pediatric surgeon decision to perform surgery for suspected NEC or IP

Exclusion Criteria:

  • Decision not to treat
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223261

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Stanford University
Palo Alto, California, United States, 94304
University of California at San Diego
San Diego, California, United States, 92103-8774
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University
Charlotte, North Carolina, United States, 27157
Duke University
Durham, North Carolina, United States, 27710
RTI International
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Study Director: Martin L. Blakely, MD The University of Texas Health Science Center, Houston
Principal Investigator: Waldemar A. Carlo, MD University of Alabama at Birmingham
Principal Investigator: William Oh, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Avroy A. Fanaroff, MD Case Western Reserve University, Rainbow Babies & Children's Hospital
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Charles R. Bauer, MD University of Miami
Principal Investigator: James A. Lemons, MD Indiana University
Principal Investigator: David K. Stevenson, MD Stanford University
Principal Investigator: Abbot R. Laptook, MD University of Texas
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Principal Investigator: Ronald N. Goldberg, MD Duke University
Principal Investigator: T. Michael O'Shea, MD MPH Wake Forest School of Medicine
Principal Investigator: Dale L. Phelps, MD University of Rochester
Principal Investigator: Neil N. Finer, MD University of California, San Diego
Principal Investigator: W. Kenneth Poole, PhD RTI International
  More Information

Additional Information:
Publications:
Responsible Party: Martin L. Blakely, Lead Principal Investigator, University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier: NCT01223261     History of Changes
Other Study ID Numbers: NICHD-NRN-0027, U10HD034216, U10HD027904, U10HD021364, M01RR000080, U10HD027853, M01RR008084, U10HD027851, M01RR000039, U10HD021397, M01RR016587, U10HD027856, M01RR000750, U10HD027880, M01RR000070, U10HD040689, M01RR000633, U10HD021373, U10HD021385, U10HD027871, M01RR006022, U10HD040492, M01RR000030, U10HD040498, M01RR007122, U10HD040521, M01RR000044, U10HD040461, U10HD036790
Study First Received: October 14, 2010
Last Updated: October 14, 2010
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 performation

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 October 29, 2014