Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study

December 14, 2018 updated by: Lindsay Ryerson, University of Alberta
Infants with heterotaxy syndrome (HS) are born with an abnormal arrangement of organs along the right-left body axis. Abnormalities of intestinal rotation and fixation are commonly associated with HS. Malrotation is the most worrisome intestinal rotation abnormality (IRA). Advances in cardiac surgery have improved HS mortality such that there is increasing attention to IRA and their management. The objective of this research project is to prospectively observe a cohort of infants with HS and IRA and evaluate their long term outcomes. Specifically, the investigators would like to determine what is the natural history of asymptomatic IRA in patients with HS and what is the morbidity and mortality secondary to an elective Ladd procedure for asymptomatic IRA in a population with HS? The investigators plan a prospective, multi-center, observational study to follow this complicated group of patients. This will be a web-based database collected from major cardiac tertiary care centers in both Canada and the United States. Patients with HS will be recruited by their primary site and clinical data will be collected by their primary site prospectively throughout childhood until they are at least five years of age. This patient population will be followed by their own clinical care givers; this is not an interventional study. No additional clinic visits will be required and the patients will not have to be contacted. Patient medical records will be accessed by a member of the study team at the primary site at least once per year or more frequently if interventions are required or complications develop.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All infants with heteterotaxy syndrome whose families provide written informed consent.

Description

Inclusion Criteria:

  • All infants less than or equal to six months of age with a new diagnosis of heterotaxy syndrome

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Infants with heterotaxy syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Midgut volvulus
Time Frame: First year of life
Surgical intervention
First year of life

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidity secondary to a prophylactic Ladd procedure
Time Frame: Post Ladd procedure
Post Ladd procedure
Mortality secondary to a prophylactic Ladd procedure
Time Frame: Within one month of Ladd procedure
Within one month of Ladd procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Lindsay Ryerson, MD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 3, 2012

First Posted (ESTIMATE)

May 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 14, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-LR-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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