Feasibility Study for PANDAS

Feasibility Study for Pediatric NeuroDevelopmental Assessment Study (PANDAS)

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia; Developmental Delay Disorders

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.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Children's Anesthesiology Associates, Ltd.
• Investigators: Principal Investigator: Ronald Litman, DO, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 16, 2008
• First Submitted That Met QC Criteria: September 17, 2008
• First Posted (Estimate): September 18, 2008

Study Record Updates

• Last Update Posted (Estimate): September 16, 2009
• Last Update Submitted That Met QC Criteria: September 14, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Anesthesia; Phone Interview; Inguinal Hernia; Neurologic Examination; Siblings; Developmental Delay Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Pathological Conditions, Anatomical; Hernia, Abdominal; Neurodevelopmental Disorders; Hernia; Hernia, Inguinal; Developmental Disabilities
• Other Study ID Numbers: 2008-06-7001