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NCT01506531 Clinical Trial

Silo Versus Primary Closure for Gastroschisis

Gastroschisis Clinical Trial

Official title:
Bedside Silo Versus Attempted Operative Closure for Gastroschisis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01506531
Other study ID # 11 09-156
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2011
Est. completion date April 2018

Study information
Verified date January 2019
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date April 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Days
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• silo for gastroschisis
silo placed around abdominal contents in gastroschisis patients
• Primary closure of gastroschisis
Primary closure of gastroschisis, if possible

Locations
Country Name City State
United States Children's Mercy Hospital Kansas City Missouri

Sponsors (1)
Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of hospitalization The length of time required for meeting discharge criteria 1-6 weeks
See also
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Recruiting NCT06072976 - The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies N/A