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Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis (NEST)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by NICHD Neonatal Research Network
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT01029353
First received: December 9, 2009
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
This trial 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.

Condition Intervention
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Enterocolitis, Necrotizing Intestinal Perforation Procedure: Laparotomy Procedure: Drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Trial of Laparotomy vs. Drainage as the Initial Surgical Therapy for ELBW Infants With Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP): Outcomes at 18-22 Months Adjusted Age

Resource links provided by NLM:


Further study details as provided by NICHD Neonatal Research Network:

Primary Outcome Measures:
  • Death or neurodevelopmental impairment [ Time Frame: Up to 18-22 months corrected age ]

Secondary Outcome Measures:
  • Surgical complications [ Time Frame: Up to 18-22 months corrected age ]
  • Number of surgical procedures [ Time Frame: Up to 18-22 months corrected age ]
  • Sepsis episodes [ Time Frame: Up to 18-22 months corrected age ]
  • Duration of parenteral nutrition [ Time Frame: Up to 18-22 months corrected age ]
  • Parenteral nutrition associated cholestasis [ Time Frame: Up to 18-22 months corrected age ]
  • Length of hospital stay [ Time Frame: Until hospital discharge ]
  • Rehospitalizations [ Time Frame: Up to 18-22 months corrected age ]

Estimated Enrollment: 310
Study Start Date: January 2010
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparotomy 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.
Active Comparator: Peritoneal drain placement Procedure: Drainage
Initial drainage will involve placing a Penrose drain in the abdomen.
Other Name: Peritoneal drain

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 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 is 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 trial uses a comprehensive cohort design that adds to the conventional randomized trial design, as a secondary specific aim. In addition to collecting detailed information on the randomized infants, we will also collect information on non-randomized infants with NEC/IP who are officially enrolled into a preference cohort.

  Eligibility

Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029353

Contacts
Contact: Martin L. Blakely, MD 615-936-7211
Contact: Rosemary D. Higgins, MD 301-496-5575

  Show 22 Study Locations
Sponsors and Collaborators
NICHD Neonatal Research Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: 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
Study Director: Martin K. Blakely, MD University of Tennessee Health Science Center
Principal Investigator: 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
  More Information

Additional Information:
Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT01029353     History of Changes
Other Study ID Numbers: NICHD-NRN-0039
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
U10HD053089 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD053119 ( U.S. NIH Grant/Contract )
U10HD053124 ( U.S. NIH Grant/Contract )
UL1RR024139 ( U.S. NIH Grant/Contract )
UL1RR025744 ( U.S. NIH Grant/Contract )
UL1RR025764 ( U.S. NIH Grant/Contract )
UL1RR025777 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
UL1RR024979 ( U.S. NIH Grant/Contract )
U10HD068284 ( U.S. NIH Grant/Contract )
U10HD068278 ( U.S. NIH Grant/Contract )
U10HD068270 ( U.S. NIH Grant/Contract )
U10HD068263 ( U.S. NIH Grant/Contract )
U10HD068244 ( U.S. NIH Grant/Contract )
UG1HD087226 ( U.S. NIH Grant/Contract )
Study First Received: December 9, 2009
Last Updated: September 20, 2016

Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Very Low Birth Weight (VLBW)
Extremely Low Birth Weight (ELBW)
Prematurity
Laparotomy
Drainage
Isolated intestinal perforation
Focal intestinal perforation

Additional relevant MeSH terms:
Birth Weight
Enterocolitis
Enterocolitis, Necrotizing
Intestinal Perforation
Body Weight
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 21, 2017