NEC Surgery: Observational Study of Surgical Treatment of Necrotizing Enterocolotis

Sponsor

NICHD Neonatal Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT01223261

Collaborator

National Center for Research Resources (NCRR) (NIH)

156

Enrollment

Locations

Duration (Months)

9.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Enterocolitis, Necrotizing Intestinal Perforation

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 Design

Study Type:

Observational

Actual Enrollment :

156 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Study of Surgical Treatment of Necrotizing Enterocolotis or Isolated Intestinal Perforation

Study Start Date :

Mar 1, 2001

Actual Primary Completion Date :

Sep 1, 2002

Actual Study Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Feasibility of conducting a randomized trial [1 year]
Ability to enroll infants in a 1-year period

Secondary Outcome Measures

Document variation in current surgical practices [Until hospital discharge or 120 days of life]
Prevalence of infants who would qualify for the study [Until hospital discharge or 120 days of life]
Frequency of postoperative complications [Until hospital discharge or 120 days of life]
Neurodevelopmental impairment [18-22 months corrected age]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Stanford University	Palo Alto	California	United States	94304
3	University of California at San Diego	San Diego	California	United States	92103-8774
4	Yale University	New Haven	Connecticut	United States	06504
5	University of Miami	Miami	Florida	United States	33136
6	Emory University	Atlanta	Georgia	United States	30303
7	Indiana University	Indianapolis	Indiana	United States	46202
8	Wayne State University	Detroit	Michigan	United States	48201
9	University of Rochester	Rochester	New York	United States	14642
10	Wake Forest University	Charlotte	North Carolina	United States	27157
11	RTI International	Durham	North Carolina	United States	27705
12	Duke University	Durham	North Carolina	United States	27710
13	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States	45267
14	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
15	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
16	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235
17	University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

NICHD Neonatal Research Network
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