NCT01506531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

6.4 years

First QC Date

January 2, 2012

Last Update Submit

January 8, 2019

Conditions

Gastroschisis

Keywords

gastroschisissiloprimary closure

Outcome Measures

Primary Outcomes (1)

  • Length of hospitalization

    The length of time required for meeting discharge criteria

    1-6 weeks

Study Arms (2)

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

silo for gastroschisisPROCEDURE

silo placed around abdominal contents in gastroschisis patients

silo for gastroschisis
Primary closure of gastroschisisPROCEDURE

Primary closure of gastroschisis, if possible

primary closure of gastroschisis

Eligibility Criteria

Age5 Minutes - 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants with gastroschisis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Gastroschisis

Condition Hierarchy (Ancestors)

Musculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital and Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 10, 2012

Study Start

August 1, 2011

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)