Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis (NEST)
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| ClinicalTrials.gov Identifier: NCT01029353 |
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Recruitment Status
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Active, not recruiting
First Posted
: December 10, 2009
Last Update Posted
: November 9, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Enterocolitis, Necrotizing Intestinal Perforation | Procedure: Laparotomy Procedure: Drainage | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 310 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Actual Study Start Date : | January 2010 |
| Estimated Primary Completion Date : | April 2019 |
| Estimated Study Completion Date : | April 2019 |
| Arm | Intervention/treatment |
|---|---|
| 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.
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| Active Comparator: Peritoneal drain placement |
Procedure: Drainage
Initial drainage will involve placing a Penrose drain in the abdomen.
Other Name: Peritoneal drain
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- Death or neurodevelopmental impairment [ Time Frame: Up to 18-22 months corrected age ]
- 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 ]
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| Ages Eligible for Study: | up to 8 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029353
Show 22 Study Locations
| 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 |
Additional Information:
Keywords provided by NICHD Neonatal Research Network:
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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:
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Birth Weight Enterocolitis Enterocolitis, Necrotizing Intestinal Perforation Body Weight |
Signs and Symptoms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |