Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252681
Status:
COMPLETED
Last Update Posted:
2006-07-21
First Post:
2005-11-09
Brief Title:
Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Surgery for Necrotizing Enterocolitis in Human Infants A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies
Detailed Description:
This is a multi-center randomized clinical trial comparing laparotomy vs peritoneal drainage for perforated Necrotizing Enterocolitis The current literature does not allow an objective comparison between these two methods A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an adequate determination as to the best treatment The conclusion that only a randomized clinical trial would answer this question has led to this multi-center effort The relative infrequency of the disease at any one neonatal center has necessitated enrollment of patients at many centers
Comparison Premature neonates weighing less than 1500 grams at birth who develop perforated necrotizing enterocolitis are randomized within two birth weight blocks 1000 gms and 1000 - 1499 gms for treatment with either laparotomy or primary peritoneal drainage Daily postoperative clinical care is kept uniform between the two groups by means of a critical care pathway The primary outcome variable is mortality ie death within 90 days of intervention The main secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation
Comparison Premature neonates weighing less than 1500 grams at birth who develop perforated necrotizing enterocolitis are randomized within two birth weight blocks 1000 gms and 1000 - 1499 gms for treatment with either laparotomy or primary peritoneal drainage Daily postoperative clinical care is kept uniform between the two groups by means of a critical care pathway The primary outcome variable is mortality ie death within 90 days of intervention The main secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Gen Clin Res Ctr M01-RR00125 | None | None | None |