Observational Study of Surgical Treatment of Necrotizing Enterocolotis

Infant, Premature Clinical Trial

— NEC Surgery  

Official title:

Observational Study of Surgical Treatment of Necrotizing Enterocolotis or Isolated Intestinal Perforation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223261
• Other study ID #: NICHD-NRN-0027
• Secondary ID: U10HD034216U10HD
• Status: Completed
• Start date: March 2001
• Est. completion date: March 2004

Study information

• Verified date: March 2019
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP preoperatively and the importance of this distinction on outcome measures; and 3) to evaluate the association between extent of intestinal disease determined at operation and outcome measures. 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: March 2004
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Wake Forest University	Charlotte	North Carolina
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	RTI International	Durham	North Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Miami	Miami	Florida
United States	Yale University	New Haven	Connecticut
United States	Stanford University	Palo Alto	California
United States	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	University of Rochester	Rochester	New York
United States	University of California at San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Blakely ML, Lally KP, McDonald S, Brown RL, Barnhart DC, Ricketts RR, Thompson WR, Scherer LR, Klein MD, Letton RW, Chwals WJ, Touloukian RJ, Kurkchubasche AG, Skinner MA, Moss RL, Hilfiker ML; NEC Subcommittee of the NICHD Neonatal Research Network. Post — View Citation

Blakely ML, Tyson JE, Lally KP, McDonald S, Stoll BJ, Stevenson DK, Poole WK, Jobe AH, Wright LL, Higgins RD; NICHD Neonatal Research Network. Laparotomy versus peritoneal drainage for necrotizing enterocolitis or isolated intestinal perforation in extrem — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of conducting a randomized trial	Ability to enroll infants in a 1-year period	1 year
Secondary	Document variation in current surgical practices		Until hospital discharge or 120 days of life
Secondary	Prevalence of infants who would qualify for the study		Until hospital discharge or 120 days of life
Secondary	Frequency of postoperative complications		Until hospital discharge or 120 days of life
Secondary	Neurodevelopmental impairment		18-22 months corrected age

External Links

•   NICHD Neonatal Research Network