Heterotaxy Syndrome and Intestinal Rotation Abnormalities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heterotaxy Syndrome

Keywords

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Pediatrics Congenital heart disease Heterotaxy syndrome Intestinal malrotation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infants with heterotaxy syndrome

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Lindsay Ryerson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lindsay Ryerson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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2012-LR-01

Identifier Type: -

Identifier Source: org_study_id

Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study