Observational Study of Surgical Treatment of Necrotizing Enterocolotis

NCT01223261 | Completed

• 29 other identifiers: NICHD-NRN-0027U10HD034216U10HD027904U10HD021364M01RR000080U10HD027853M01RR008084U10HD027851M01RR000039U10HD021397M01RR016587U10HD027856M01RR000750U10HD027880M01RR000070U10HD040689M01RR000633U10HD021373U10HD021385U10HD027871M01RR006022U10HD040492M01RR000030U10HD040498M01RR007122U10HD040521M01RR000044U10HD040461U10HD036790
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 17

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.

Conditions

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

Keywords

NICHD Neonatal Research Network; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW); Prematurity; Laparotomy; Drainage; Isolated intestinal perforation; Focal intestinal performation

Outcome Measures

Primary Outcomes (1)

• Feasibility of conducting a randomized trial

  Ability to enroll infants in a 1-year period

  1 year

Secondary Outcomes (4)

• 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

• Age: Up to 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Decision not to treat

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (17)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California at San Diego

San Diego, California, 92103-8774, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Wake Forest University

Charlotte, North Carolina, 27157, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Blakely ML, Lally KP, McDonald S, Brown RL, Barnhart DC, Ricketts RR, Thompson WR, Scherer LR, Klein MD, Letton RW, Chwals WJ, Touloukian RJ, Kurkchubasche AG, Skinner MA, Moss RL, Hilfiker ML; NEC Subcommittee of the NICHD Neonatal Research Network. Postoperative outcomes of extremely low birth-weight infants with necrotizing enterocolitis or isolated intestinal perforation: a prospective cohort study by the NICHD Neonatal Research Network. Ann Surg. 2005 Jun;241(6):984-9; discussion 989-94. doi: 10.1097/01.sla.0000164181.67862.7f.

  PMID: 15912048 RESULT

• Blakely ML, Tyson JE, Lally KP, McDonald S, Stoll BJ, Stevenson DK, Poole WK, Jobe AH, Wright LL, Higgins RD; NICHD Neonatal Research Network. Laparotomy versus peritoneal drainage for necrotizing enterocolitis or isolated intestinal perforation in extremely low birth weight infants: outcomes through 18 months adjusted age. Pediatrics. 2006 Apr;117(4):e680-7. doi: 10.1542/peds.2005-1273. Epub 2006 Mar 20.

  PMID: 16549503 RESULT

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing; Intestinal Perforation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Martin L. Blakely, MD

  The University of Texas Health Science Center, Houston

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: March 1, 2001
• Primary Completion: September 1, 2002
• Study Completion: March 1, 2004
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (17)