Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

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

Interventions

PROCEDURE

Laparotomy

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.

PROCEDURE

Drainage

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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Abbot R. Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• Michele C. Walsh, MD MS · Case Western Reserve University, Rainbow Babies and Children's Hospital

• C. Michael Cotten, MD · Duke University

• David Carlton, MD · Emory University

• Greg Sokol, MD · Indiana University

• Abhik Das, PhD · RTI International

• Krisa P. Van Meurs, MD · Stanford University

• Ivan D. Frantz III, MD · Tufts Medical Center

• Brenda Poindexter, MD, MS · Children's Hospital Medical Center, Cincinnati

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• Edward F. Bell, MD · University of Iowa

• Kristi L. Watterberg, MD · University of New Mexico

• Myra Wyckoff, MD · University of Texas, Southwestern Medical Center at Dallas

• Kathleen A. Kennedy, MD MPH · The University of Texas Health Science Center, Houston

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• Martin K. Blakely, MD · Vanderbilt University Medical Center

• William Truog, MD · Children's Mercy Hospital Kansas City

• Barbara Schmidt, MD, MSc · Univeristy of Pennsylvania

• Carl D'Angio, MD · University of Rochester

• Uday Devaskar, MD · University of Carlifornia - Los Angeles

• Leif Nelin, MD · Research Institute at Nationwide Children's Hospital

• Brad Yoder, MD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

8 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2019-08-31

Completion

2019-08-31

Countries

• United States

Study Locations