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

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ClinicalTrials.gov Identifier: NCT01223261
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network

Tracking Information
First Submitted Date October 14, 2010
First Posted Date October 18, 2010
Last Update Posted Date March 22, 2019
Study Start Date March 2001
Actual Primary Completion Date September 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 14, 2010)
Feasibility of conducting a randomized trial [ Time Frame: 1 year ]
Ability to enroll infants in a 1-year period
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 14, 2010)
  • Document variation in current surgical practices [ Time Frame: Until hospital discharge or 120 days of life ]
  • Prevalence of infants who would qualify for the study [ Time Frame: Until hospital discharge or 120 days of life ]
  • Frequency of postoperative complications [ Time Frame: Until hospital discharge or 120 days of life ]
  • Neurodevelopmental impairment [ Time Frame: 18-22 months corrected age ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study of Surgical Treatment of Necrotizing Enterocolotis
Official Title Observational Study of Surgical Treatment of Necrotizing Enterocolotis or Isolated Intestinal Perforation
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Enterocolitis, Necrotizing
  • Intestinal Perforation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 14, 2010)
156
Original Actual Enrollment Same as current
Actual Study Completion Date March 2004
Actual Primary Completion Date September 2002   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 6 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01223261
Other Study ID Numbers NICHD-NRN-0027
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
M01RR000080 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
M01RR000039 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
M01RR016587 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
M01RR000633 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
M01RR006022 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
M01RR000030 ( U.S. NIH Grant/Contract )
U10HD040498 ( U.S. NIH Grant/Contract )
M01RR007122 ( U.S. NIH Grant/Contract )
U10HD040521 ( U.S. NIH Grant/Contract )
M01RR000044 ( U.S. NIH Grant/Contract )
U10HD040461 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Martin L. Blakely, Lead Principal Investigator, University of Texas Health Science Center at Houston
Study Sponsor NICHD Neonatal Research Network
Collaborators National Center for Research Resources (NCRR)
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 University
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
PRS Account NICHD Neonatal Research Network
Verification Date March 2019