Observational Study of Surgical Treatment of Necrotizing Enterocolotis (NEC Surgery)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01223261 |
|
Recruitment Status :
Completed
First Posted : October 18, 2010
Last Update Posted : March 22, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Enterocolitis, Necrotizing Intestinal Perforation |
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 abdomin. The outcomes for infants with NEC or IP are 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 diseased intestine is removed. Infants treated with an initial drainage sometimes go on to need a laparotomy. Most surgeons now believe that a diagnosis of the intestinal perforation (IP) may actually be either true NEC or a different and distinct pathology, termed isolated intestinal perforation. The ability to distinguish these 2 conditions preoperatively, based on perinatal characteristics, physical examination findings, and findings on abdominal plain film imaging, remains unknown. If these 2 entities can be distinguished preoperatively, the intervention chosen and outcomes may be different. From the two available surgical options, tt is not known whether initial laparotomy or peritoneal drain placement is more effective for either NEC or IP.
This study was a prospective, multicenter observational study to describe the surgical outcomes (mortality, post-operative intestinal stricture, intra-abdominal abscess formation, etc.) in ELBW infants with either NEC or IP who underwent initial laparotomy or peritoneal drainage. We also evaluated the ability of surgeons to distinguish NEC and IP pre-operatively and the relevance of this distinction on outcome. Finally, an analysis of the impact of extent of intestinal involvement with NEC on outcome measures is reported.
All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications.
Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.
| Study Type : | Observational |
| Actual Enrollment : | 156 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Observational Study of Surgical Treatment of Necrotizing Enterocolotis or Isolated Intestinal Perforation |
| Study Start Date : | March 2001 |
| Actual Primary Completion Date : | September 2002 |
| Actual Study Completion Date : | March 2004 |
- Feasibility of conducting a randomized trial [ Time Frame: 1 year ]Ability to enroll infants in a 1-year period
- Document variation in current surgical practices [ Time Frame: Until hospital discharge or 120 days of life ]
- Prevalence of infants who would qualify for the study [ Time Frame: Until hospital discharge or 120 days of life ]
- Frequency of postoperative complications [ Time Frame: Until hospital discharge or 120 days of life ]
- Neurodevelopmental impairment [ Time Frame: 18-22 months corrected age ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 6 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Infants born 401-1,000 grams at birth enrolled in the NRN Generic Database
- Sage III NEC or isolated intestinal perforation
- Pediatric surgeon decision to perform surgery for suspected NEC or IP
Exclusion Criteria:
- Decision not to treat
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): NCT01223261
Show 17 study locations
| Study Director: | Martin L. Blakely, MD | The University of Texas Health Science Center, Houston | |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham | |
| Principal Investigator: | William Oh, MD | Brown University, Women & Infants Hospital of Rhode Island | |
| Principal Investigator: | Avroy A. Fanaroff, MD | Case Western Reserve University, Rainbow Babies & Children's Hospital | |
| Principal Investigator: | Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University | |
| Principal Investigator: | Charles R. Bauer, MD | University of Miami | |
| Principal Investigator: | James A. Lemons, MD | Indiana University | |
| Principal Investigator: | David K. Stevenson, MD | Stanford University | |
| Principal Investigator: | Abbot R. Laptook, MD | University of Texas | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University | |
| Principal Investigator: | Ronald N. Goldberg, MD | Duke University | |
| Principal Investigator: | T. Michael O'Shea, MD MPH | Wake Forest University | |
| Principal Investigator: | Dale L. Phelps, MD | University of Rochester | |
| Principal Investigator: | Neil N. Finer, MD | University of California, San Diego | |
| Principal Investigator: | W. Kenneth Poole, PhD | RTI International |
Publications of Results:
|
NICHD Neonatal Research Network Very Low Birth Weight (VLBW) Extremely Low Birth Weight (ELBW) Prematurity |
Laparotomy Drainage Isolated intestinal perforation Focal intestinal performation |
|
Enterocolitis Intestinal Perforation Enterocolitis, Necrotizing Birth Weight Body Weight |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |