Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

529 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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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 abdominal cavity. Outcome for infants with NEC and/or IP is 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 necrotic intestine is removed. Drainage may be followed by a laparotomy.

The Neonatal Research Network's observational study of 156 ELBW infants with NEC or IP (Pediatrics. 2006 Apr; 117(4): e680-7) showed comparable outcomes for the two procedures before hospital discharge, but suggested an advantage of laparotomy over drainage at 18-22 months corrected age with lower rates of death or neurodevelopmental impairment. However, the infants that underwent laparotomy were more mature; infants with drains were smaller and more premature. We hypothesize that initial laparotomy may improve an infant's long-term neurodevelopmental outcome, potentially by reducing the maximum severity or duration of inflammation.

This study included a randomized controlled trial to compare the effectiveness of laparotomy versus drainage for treating NEC or IP in extremely low birth weight infants. Target enrollment is 300 infants diagnosed with NEC or IP for randomization to receive initially either a laparotomy or drainage. Subsequent laparotomies may be performed on infants in either group, if their condition continues to deteriorate. Surviving infants will return for a follow-up assessment at 18-22 months corrected age.

This study also attempted to use a comprehensive cohort design that would have added additional information beyond the conventional randomized trial component. The cohort component included trial data among eligible, non-randomized infants with NEC/IP, who consented for the non-randomized cohort, would be collected and analyzed as a secondary specific aim. This additional cohort was called the preference cohort.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Randomized Trial: Laparotomy

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

Group Type ACTIVE_COMPARATOR

Laparotomy

Intervention Type 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.

Randomized Trial: Peritoneal drain placement

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

Group Type ACTIVE_COMPARATOR

Drainage

Intervention Type PROCEDURE

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

Preference Cohort: Laparotomy

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

Group Type ACTIVE_COMPARATOR

Laparotomy

Intervention Type 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: Peritoneal drain placement

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

Group Type ACTIVE_COMPARATOR

Drainage

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Drainage

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

Intervention Type PROCEDURE

Other Intervention Names

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Peritoneal drain

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abbot R. Laptook, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Women & Infants Hospital of Rhode Island

Michele C. Walsh, MD MS

Role: PRINCIPAL_INVESTIGATOR

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

C. Michael Cotten, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

David Carlton, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Greg Sokol, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Abhik Das, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Krisa P. Van Meurs, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Ivan D. Frantz III, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Brenda Poindexter, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Waldemar A. Carlo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Edward F. Bell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Kristi L. Watterberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Myra Wyckoff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Kathleen A. Kennedy, MD MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Seetha Shankaran, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Richard A. Ehrenkranz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Martin K. Blakely, MD

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

William Truog, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Barbara Schmidt, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Pennsylvania

Carl D'Angio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Uday Devaskar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Carlifornia - Los Angeles

Leif Nelin, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute at Nationwide Children's Hospital

Brad Yoder, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of California - Los Angeles

Los Angeles, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

RTI International

Durham, North Carolina, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Univeristy of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 37169336 (View on PubMed)

Provided Documents

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