Feasibility Study for PANDAS

NCT ID: NCT00754897

Last Updated: 2009-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-07-31

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.

Detailed Description

Feasibility study to obtain information through a telephone interview with parents of eligible children Once we identify the children who were less than one year of age and those between the ages of 1 and 3 that who had inguinal hernia surgery during the years of 1999-2007, we will call the parents to determine if the index patients have siblings. If so, we would also ask if there is a sibling within 3 years of the index patient's age and if they have had no exposure to anesthetics or sedatives before their third birthday. Exclusion criteria for both index patients and siblings would include gestational age at birth of < 36 weeks, any history of hospitalization, including neonatal ICU, a history of CNS, cardiac, or pulmonary diseases requiring medical treatment, or a history of subsequent surgery or exposure of anesthetics or sedatives.

Conditions

Inguinal Hernia; Developmental Delay Disorders

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Males or females age 0 to 1 year.

2. Inguinal hernia surgery between 1/1/1999 and 12/31/2007.

3. Parental/guardian permission (informed consent).

Exclusion Criteria

1. Gestational age < 36 weeks.

2. Any history of hospitalization, including neonatal ICU.

3. A history of CNS, cardiac, or pulmonary diseases requiring medical treatment.

4. History of subsequent surgery or exposure to anesthetics or sedatives at less than 3 years of age.

-

• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Anesthesiology Associates, Ltd.

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

The Children's Hospital of Philadelphia

Principal Investigators

Ronald Litman, DO

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2008-06-7001

Identifier Type: -

Identifier Source: org_study_id