Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Feasibility Study for PANDAS
This study is not yet open for participant recruitment.
Verified by Children's Hospital of Philadelphia, September 2008
Sponsors and Collaborators: Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Information provided by: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00754897
  Purpose

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.


Condition
Inguinal Hernia
Developmental Delay Disorders

MedlinePlus related topics: Anesthesia Hernia
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Retrospective
Official Title: Feasibility Study for Pediatric NeuroDevelopmental Assessment Study (PANDAS)

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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. [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


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.

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754897

Contacts
Contact: Ari Weintraub, MD 267-426-9640 weintraub@email.chop.edu
Contact: Theodora K. Goebel, RN, BSN 215-590-4925 goebelt@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Investigators
Principal Investigator: Ronald Litman, DO Children's Hospital of Philadelphia
  More Information

Responsible Party: The Children's Hospital of Philadelphia ( Ronald Litman, DO )
Study ID Numbers: 2008-06-7001
Study First Received: September 16, 2008
Last Updated: September 17, 2008
ClinicalTrials.gov Identifier: NCT00754897  
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Phone Interview
Anesthesia
Siblings
Inguinal Hernia
Neurologic Examination
Developmental Delay Disorders

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Developmental Disabilities
Mental Disorders
Hernia
Mental Disorders Diagnosed in Childhood
Hernia, Abdominal
Hernia, Inguinal

ClinicalTrials.gov processed this record on January 13, 2009