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Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study

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ClinicalTrials.gov Identifier: NCT01591928
Recruitment Status : Completed
First Posted : May 4, 2012
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Lindsay Ryerson, University of Alberta

Brief Summary:
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.

Condition or disease
Heterotaxy Syndrome

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study
Study Start Date : March 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Infants with heterotaxy syndrome



Primary Outcome Measures :
  1. Midgut volvulus [ Time Frame: First year of life ]

Secondary Outcome Measures :
  1. Morbidity secondary to a prophylactic Ladd procedure [ Time Frame: Post Ladd procedure ]
  2. Mortality secondary to a prophylactic Ladd procedure [ Time Frame: Within one month of Ladd procedure ]


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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All infants with heteterotaxy syndrome whose families provide written informed consent.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591928


Locations
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Lindsay Ryerson, MD University of Alberta

Responsible Party: Lindsay Ryerson, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01591928     History of Changes
Other Study ID Numbers: 2012-LR-01
First Posted: May 4, 2012    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lindsay Ryerson, University of Alberta:
Pediatrics
Congenital heart disease
Heterotaxy syndrome
Intestinal malrotation

Additional relevant MeSH terms:
Heterotaxy Syndrome
Syndrome
Disease
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Splenic Diseases
Lymphatic Diseases
Abnormalities, Multiple
Congenital Abnormalities