Feasibility Study for PANDAS

NCT00754897 | Completed

• 1 other identifier: 2008-06-7001
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

We have been asked to participate in the Pediatric Anesthesia NeuroDevelopmental Assessment Study (PANDAS), which is a study to compare neurocognitive functions in sibling pairs: one of whom had exposure to anesthesia during inguinal hernia surgery before three years of age (exposed) and the other who was not exposed to anesthesia or surgery in the first three years of life (unexposed). A consortium of approximately 6 hospitals is doing this feasibility study to determine if there is an adequate number of subjects for each of the two age groups before the formal study begins.

Conditions

Inguinal Hernia; Developmental Delay Disorders

Keywords

Phone Interview; Anesthesia; Siblings; Inguinal Hernia; Neurologic Examination; Developmental Delay Disorders

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this feasibility study is to determine if there is an adequate population of sibling pairs at CHOP to warrant participation in a future PANDAS study.

  6-9 months

Study Arms (1)

1

We will do a database search to identify children less than 1 year of age that have undergone inguinal hernia surgery during the years of 1999-2007, and children who have had inguinal hernia surgery between the ages of 1 and 3 years during the years 1999-2007. We will then do a telephone interview of the parents of these children to determine if there are siblings that are within three years of age and have not have any exposure to anesthetics agents or sedatives before their 3rd birthday.

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children less than 1 year of age that have undergone inguinal hernia surgery during the years of 1999-2007, and children who have had inguinal hernia surgery between the ages of 1 and 3 years during the years 1999-2007. We will then do a telephone interview of the parents of these children to determine if there are siblings that are within three years of age and have not had any exposure to anesthetics agents or sedatives before their 3rd birthday.

You may qualify if:

• Males or females age 0 to 1 year.
• Inguinal hernia surgery between 1/1/1999 and 12/31/2007.
• Parental/guardian permission (informed consent).

You may not qualify if:

• Gestational age \< 36 weeks.
• Any history of hospitalization, including neonatal ICU.
• A history of CNS, cardiac, or pulmonary diseases requiring medical treatment.
• History of subsequent surgery or exposure to anesthetics or sedatives at less than 3 years of age.

Sponsors & Collaborators

• Children's Anesthesiology Associates, Ltd.: collaborator
• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal; Developmental Disabilities

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ronald Litman, DO

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 16, 2009

Record last verified: 2009-09

Locations

US (1)