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NCT02707939 Clinical Trial

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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02707939
Other study ID # P00021473
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2016
Est. completion date December 2022

Study information
Verified date February 2022
Source Boston Children's Hospital
Contact Erin Halpin, MSN, RN
Phone 857-218-4585
Email erin.halpin@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Patients will be observed before and after they receive anesthesia

Locations
Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Arnold B, Elliott A, Laohamroonvorapongse D, Hanna J, Norvell D, Koh J. Autistic children and anesthesia: is their perioperative experience different? Paediatr Anaesth. 2015 Nov;25(11):1103-10. doi: 10.1111/pan.12739. Epub 2015 Sep 4. — View Citation

Taghizadeh N, Davidson A, Williams K, Story D. Autism spectrum disorder (ASD) and its perioperative management. Paediatr Anaesth. 2015 Nov;25(11):1076-84. doi: 10.1111/pan.12732. Epub 2015 Aug 6. Review. — View Citation

van der Walt JH, Moran C. An audit of perioperative management of autistic children. Paediatr Anaesth. 2001 Jul;11(4):401-8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of postoperative behavioral changes in the participants up to two weeks following anesthesia
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