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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01029353
Other study ID # NICHD-NRN-0039
Secondary ID U10HD021364U10HD
Status Completed
Phase N/A
First received
Last updated
Start date January 2010
Est. completion date August 2019

Study information

Verified date November 2021
Source NICHD Neonatal Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 529
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 8 Weeks
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States Emory University Atlanta Georgia
United States University of Alabama at Birmingham Birmingham Alabama
United States Tufts Medical Center Boston Massachusetts
United States Cincinnati Children's Medical Center Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States Research Institute at Nationwide Children's Hospital Columbus 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 Iowa Iowa City Iowa
United States Children's Mercy Hospital Kansas City Missouri
United States University of California - Los Angeles Los Angeles California
United States Yale University New Haven Connecticut
United States Stanford University Palo Alto California
United States Univeristy of Pennsylvania Philadelphia Pennsylvania
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 Utah Salt Lake City Utah

Sponsors (3)

Lead Sponsor Collaborator
NICHD Neonatal Research Network Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death or Neurodevelopmental Impairment (NDI) Death or NDI at 18-22 months corrected age at 18-22 months corrected age
Secondary Death Death by 18-22 months corrected age by 18-22 months corrected age
Secondary Survival With Neurodevelopmental Impairment (NDI) NDI at 18-22 months corrected age (among survivors) by 18-22 months corrected age
Secondary Death or Moderate to Severe Cerebral Palsy Death within 18-22 months corrected age or moderate to severe cerebral palsy at 18-22 months corrected age up to the follow-up visit completed within the 18-22 months corrected age window
Secondary Death or Bayley Cognitive Composite Score Less Than 85 Death within 18-22 months corrected age or Bayley cognitive composite score less than 85 at 18-22 months corrected age. Higher values of the Bayley cognitive composite score is better than lower values. Normal values are greater than or equal to 85. A moderate value is in the 70-84 range, and a severe value is <70. up to the follow-up visit completed within the 18-22 months corrected age window
Secondary Death or Blindness Death within 18-22 months corrected age or blindness at 18-22 months corrected age up to the follow-up visit completed within the 18-22 months corrected age window
Secondary Death or Hearing Loss Death within 18-22 months corrected age or hearing loss at 18-22 months corrected age up to the follow-up visit completed within the 18-22 months corrected age window
Secondary Subsequent Laparotomy Subsequent laparotomy after initial surgery between initial surgery and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Intraoperative Complications During Any Surgery Any intraoperative complications during any surgery between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Wound Dehiscence Any wound dehiscence during any surgery between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Intra-abdominal Abscess Any intra-abdominal abscess during any surgery between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Intestinal Stricture Any intestinal stricture during any surgery between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Late Onset Sepsis Any late onset sepsis after randomization between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Parenteral Nutrition (PN)-Associated Cholestasis Any Parenteral nutrition (PN)-associated cholestasis during any surgery between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Severe IVH Any severe IVH ater randomization between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Duration of Mechanical Ventilation Duration of mechanical ventilation while on study between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Duration of Parenteral Nutrition Duration of parenteral nutrition while on study between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Final Bowel Length Final bowel length after last surgery between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Time to Full Feeds Time to full feeds while on study between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Length of Hospital Stay Length of hospital stay while on study from randomization up to 1 year following birth
Secondary Death or NDI Stratified by Pre-operative Diagnosis Death or NDI at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). at 18-22 months corrected age
Secondary Death Stratified by Pre-operative Diagnosis Death within 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). by 18-22 months corrected age
Secondary Survival With Neurodevelopmental Impairment (NDI) Stratified by Pre-operative Diagnosis NDI at 18-22 months corrected age (among survivors). Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). by 18-22 months corrected age
Secondary Death or Moderate to Severe Cerebral Palsy Stratified by Pre-operative Diagnosis Death within 18-22 months corrected age or moderate to severe cerebral palsy at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). up to the follow-up visit completed within the 18-22 months corrected age window
Secondary Death or Bayley Cognitive Composite Score Less Than 85 Stratified by Pre-operative Diagnosis Death within 18-22 months corrected age or Bayley cognitive composite score less than 85 at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). Higher values of the Bayley cognitive composite score is better than lower values. Normal values are greater than or equal to 85. A moderate value is in the 70-84 range, and a severe value is <70. up to the follow-up visit completed within the 18-22 months corrected age window
Secondary Death or Blindness Stratified by Pre-operative Diagnosis Death within 18-22 months corrected age or blindness at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). up to the follow-up visit completed within the 18-22 months corrected age window
Secondary Death or Hearing Loss Stratified by Pre-operative Diagnosis Death within 18-22 months corrected age or hearing loss at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). up to the follow-up visit completed within the 18-22 months corrected age window
Secondary Subsequent Laparotomy Stratified by Pre-operative Diagnosis Subsequent laparotomy after initial surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Intraoperative Complications During Any Surgery Stratified by Pre-operative Diagnosis Any intraoperative complications during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Wound Dehiscence Stratified by Pre-operative Diagnosis Any wound dehiscence during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Intra-abdominal Abscess Stratified by Pre-operative Diagnosis Any intra-abdominal abscess during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Intestinal Stricture Stratified by Pre-operative Diagnosis Any intestinal stricture during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Late Onset Sepsis Stratified by Pre-operative Diagnosis Any late onset sepsis after randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Parenteral Nutrition (PN)-Associated Cholestasis Stratified by Pre-operative Diagnosis Any Parenteral nutrition (PN)-associated cholestasis during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Any Severe IVH Stratified by Pre-operative Diagnosis Any severe IVH ater randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Duration of Mechanical Ventilation Stratified by Pre-operative Diagnosis Duration of mechanical ventilation while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Duration of Parenteral Nutrition Stratified by Pre-operative Diagnosis Duration of parenteral nutrition while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Final Bowel Length Stratified by Pre-operative Diagnosis Final bowel length after last surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Time to Full Feeds Stratified by Pre-operative Diagnosis Time to full feeds while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Secondary Length of Hospital Stay Stratified by Pre-operative Diagnosis Length of hospital stay while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). from randomization up to 1 year following birth
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