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Silo Versus Primary Closure for Gastroschisis

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ClinicalTrials.gov Identifier: NCT01506531
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date  ICMJE January 2, 2012
First Posted Date  ICMJE January 10, 2012
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE August 2011
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2012)
Length of hospitalization [ Time Frame: 1-6 weeks ]
The length of time required for meeting discharge criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01506531 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Silo Versus Primary Closure for Gastroschisis
Official Title  ICMJE Bedside Silo Versus Attempted Operative Closure for Gastroschisis
Brief Summary The objective of this study is to scientifically evaluate two different closure strategies for gastroschisis to determine if there is a difference in the two approaches.
Detailed Description

The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay.

The primary outcome variable between the two techniques will be length of hospitalization. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroschisis
Intervention  ICMJE
  • Procedure: silo for gastroschisis
    silo placed around abdominal contents in gastroschisis patients
  • Procedure: Primary closure of gastroschisis
    Primary closure of gastroschisis, if possible
Study Arms  ICMJE
  • Active Comparator: primary closure of gastroschisis
    Attempt primary skin closure of gastroschisis shortly after birth
    Intervention: Procedure: Primary closure of gastroschisis
  • Active Comparator: silo for gastroschisis
    Surgical placement of silo over gastroschisis shortly after birth
    Intervention: Procedure: silo for gastroschisis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2019)
38
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2012)
100
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants with gastroschisis

Exclusion Criteria:

  • Born prior to 34 weeks estimated gestational age
  • Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.
  • Inability to get parental permission before treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01506531
Other Study ID Numbers  ICMJE 11 09-156
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shawn St. Peter, Children's Mercy Hospital Kansas City
Study Sponsor  ICMJE Children's Mercy Hospital Kansas City
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital and Clinics
PRS Account Children's Mercy Hospital Kansas City
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP