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 : December 19, 2018
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Condition or disease |
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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 |

Group/Cohort |
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Infants with heterotaxy syndrome |
- Midgut volvulus [ Time Frame: First year of life ]Surgical intervention
- Morbidity secondary to a prophylactic Ladd procedure [ Time Frame: Post Ladd procedure ]
- 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 |
Inclusion Criteria:
- All infants less than or equal to six months of age with a new diagnosis of heterotaxy syndrome
Exclusion Criteria:

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
Canada, Alberta | |
Stollery Children's Hospital | |
Edmonton, Alberta, Canada, T6G 2B7 |
Principal Investigator: | Lindsay Ryerson, MD | University of Alberta |
Responsible Party: | Lindsay Ryerson, Assistant Professor, University of Alberta |
ClinicalTrials.gov Identifier: | NCT01591928 |
Other Study ID Numbers: |
2012-LR-01 |
First Posted: | May 4, 2012 Key Record Dates |
Last Update Posted: | December 19, 2018 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Pediatrics Congenital heart disease Heterotaxy syndrome Intestinal malrotation |
Heterotaxy Syndrome Syndrome Disease Pathologic Processes Congenital Abnormalities Heart Defects, Congenital |
Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Splenic Diseases Lymphatic Diseases Abnormalities, Multiple |