Silo Versus Primary Closure for Gastroschisis | NCT01506531

Studies
Silo Versus Primary Closure for Gastroschisis

NCT01506531

Sponsor

Children's Mercy Hospital Kansas City

Status

Completed

Last Update Posted

Jan 10, 2019Actual

Enrollment

38Actual

Phase

Not Applicable

Conditions

Gastroschisis

Interventions

silo for gastroschisis
Primary closure of gastroschisis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Jan 2, 2012

First Submission Date that Met QC Criteria

Jan 9, 2012

First Posted Date

Jan 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2019

Last Update Posted Date

Jan 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shawn St. Peter, Associate Professor, Children's Mercy Hospital Kansas CityPrincipal Investigator

Lead Sponsor

Children's Mercy Hospital Kansas CityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
primary closure of gastroschisis	Active Comparator	Attempt primary skin closure of gastroschisis shortly after birth	Procedure: Primary closure of gastroschisis
silo for gastroschisis	Active Comparator	Surgical placement of silo over gastroschisis shortly after birth	Procedure: silo for gastroschisis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
silo for gastroschisis	Procedure	silo placed around abdominal contents in gastroschisis patients	silo for gastroschisis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of hospitalization	The length of time required for meeting discharge criteria	1-6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Minutes

Maximum Age

2 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shawn D St. Peter, MD	Children's Mercy Hospital and Clinics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Mercy Hospital		Kansas City	Missouri	64108	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020139	Gastroschisis

Ancestor Terms

ID	Term
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided