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Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses

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ClinicalTrials.gov Identifier: NCT02707939
Recruitment Status : Recruiting
First Posted : March 14, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Bistra Vlassakova, Boston Children’s Hospital

Brief Summary:
Autism Spectrum Disorder (ASD) is the fastest growing neurodevelopmental disorder in the world. Approximately 1% of the population worldwide is affected by this disorder. Children with ASD exhibit some very stereo-typical behaviors. Their daily functionality depends on very rigid and predictable schedules and routines. Any changes in their schedules can often trigger negative emotional outbursts. The need to come to the hospital for procedures can be one such trigger. The purpose of this study is to examine the post anesthesia behavior outcomes of children with ASD.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Anesthesia Other: Observation

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses
Study Start Date : February 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Autism Spectrum Disorder
Patients with a diagnosis of autism spectrum disorder
Other: Observation
Patients will be observed before and after they receive anesthesia

Controls
Patients with no developmental diagnoses
Other: Observation
Patients will be observed before and after they receive anesthesia




Primary Outcome Measures :
  1. Incidence of postoperative behavioral changes in the participants [ Time Frame: up to two weeks following anesthesia ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants with an ASD diagnosis and control patients who do not have any history of neurodevelopmental concerns who are scheduled for a procedure under anesthesia at Boston Children's Hospital.
Criteria

Inclusion Criteria:

  • Patients aged 2 years through 17 years of age scheduled for a procedure with anesthesia at Boston Children's Hospital
  • Patients must have a diagnosis of Autism Spectrum Disorder (ASD) according to the DSM IV and DSM V (autism group) or an ASA score of I or II and no history of neurodevelopmental concerns (control group)

Exclusion Criteria:

-Families who are not able to read and speak English well enough to complete the validated surveys


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): NCT02707939


Contacts
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Contact: Erin Halpin, MSN, RN 857-218-4585 erin.halpin@childrens.harvard.edu
Contact: Rachel Bernier, MPH 8572185348 rachel.bernier@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Bistra Vlassakova, MD       bistra.vlassakova@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Bistra Vlassakova, MD Boston Children’s Hospital

Publications:
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Responsible Party: Bistra Vlassakova, MD, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02707939     History of Changes
Other Study ID Numbers: P00021473
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders