Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study

This study is currently recruiting participants.
Verified October 2013 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Lindsay Ryerson, University of Alberta
ClinicalTrials.gov Identifier:
NCT01591928
First received: May 2, 2012
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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
Heterotaxy Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Risk of midgut volvulus [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Morbidity secondary to a prophylactic Ladd procedure [ Designated as safety issue: Yes ]
  • Mortality secondary to a prophylactic Ladd procedure [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Infants with heterotaxy syndrome

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591928

Contacts
Contact: Lindsay Ryerson, MD 780 407 3396 ryerson@ualberta.ca

Locations
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Lindsay Ryerson, MD    780 407 3396    ryerson@ualberta.ca   
Principal Investigator: Lindsay Ryerson, MD         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Lindsay Ryerson, MD University of Alberta
  More Information

No publications provided

Responsible Party: Lindsay Ryerson, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01591928     History of Changes
Other Study ID Numbers: 2012-LR-01
Study First Received: May 2, 2012
Last Updated: October 24, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 17, 2014