Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

NCT01029353 | Completed Results DMC

• 30 other identifiers: NICHD-NRN-0039U10HD021364U10HD021373U10HD021385U10HD027851U10HD027853U10HD027856U10HD027871U10HD027880U10HD027904U10HD034216U10HD036790U10HD040492U10HD040689U10HD053089U10HD053109U10HD053119U10HD053124UL1RR024139UL1RR025744UL1RR025764UL1RR025777M01RR008084UL1RR024979U10HD068284U10HD068278U10HD068270U10HD068263U10HD068244UG1HD087226
• Study Type: interventional
• Target: 529
• Locations: 1 country
• Sites: 22

Brief Summary

This study 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.

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 perforation

Outcome Measures

Primary Outcomes (1)

• Death or Neurodevelopmental Impairment (NDI)

  Death or NDI at 18-22 months corrected age

  at 18-22 months corrected age

Secondary Outcomes (39)

• Death

  by 18-22 months corrected age

• Survival With Neurodevelopmental Impairment (NDI)

  by 18-22 months corrected age

• Death or Moderate to Severe Cerebral Palsy

  up to the follow-up visit completed within the 18-22 months corrected age window

• Death or Bayley Cognitive Composite Score Less Than 85

  up to the follow-up visit completed within the 18-22 months corrected age window

• Death or Blindness

  up to the follow-up visit completed within the 18-22 months corrected age window

Study Arms (4)

Randomized Trial: Laparotomy

ACTIVE COMPARATOR

Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.

Procedure: Laparotomy

Randomized Trial: Peritoneal drain placement

ACTIVE COMPARATOR

Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.

Procedure: Drainage

Preference Cohort: Laparotomy

ACTIVE COMPARATOR

Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.

Procedure: Laparotomy

Preference Cohort: Peritoneal drain placement

ACTIVE COMPARATOR

Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.

Procedure: Drainage

Interventions

Laparotomy PROCEDURE

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.

Preference Cohort: Laparotomy; Randomized Trial: Laparotomy

Drainage PROCEDURE

Initial drainage will involve placing a Penrose drain in the abdomen.

Also known as: Peritoneal drain

Preference Cohort: Peritoneal drain placement; Randomized Trial: Peritoneal drain placement

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (22)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California - Los Angeles

Los Angeles, California, 90025, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, 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

Cleveland, Ohio, 44106, United States

Location

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Univeristy of Pennsylvania

Philadelphia, Pennsylvania, 19104, 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

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Rysavy MA, Eggleston B, Dahabreh IJ, Tyson JE, Patel RM, Watterberg KL, Greenberg RG, Pedroza C, Trotta M, Stevenson DK, Stoll BJ, Lally KP, Das A, Blakely ML; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Generalizability of the Necrotizing Enterocolitis Surgery Trial to the Target Population of Eligible Infants. J Pediatr. 2023 Nov;262:113453. doi: 10.1016/j.jpeds.2023.113453. Epub 2023 May 9.

  PMID: 37169336 DERIVED

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing; Intestinal Perforation

Interventions

Laparotomy; Drainage

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Therapeutics

Results Point of Contact

• Title: Martin L Blakely, MD
• Organization: Vanderbilt University Medical Center

martin.blakely@vumc.org

615-936-7211

Study Officials

• 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

• C. Michael Cotten, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• David Carlton, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Greg Sokol, MD

  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

• Brenda Poindexter, MD, MS

  Children's Hospital Medical Center, Cincinnati

  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

• Myra Wyckoff, 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

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Richard A. Ehrenkranz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Martin K. Blakely, MD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

• William Truog, MD

  Children's Mercy Hospital Kansas City

  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

  PRINCIPAL INVESTIGATOR

• Brad Yoder, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: January 1, 2010
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 18, 2024
• Results First Posted: November 23, 2021

Record last verified: 2024-07

Locations

US (22)