Feasibility Study for PANDAS

This study has been completed.
Sponsor:
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00754897
First received: September 16, 2008
Last updated: September 14, 2009
Last verified: September 2009
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Feasibility Study for Pediatric NeuroDevelopmental Assessment Study (PANDAS)

Resource links provided by NLM:


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 ]

Enrollment: 72
Study Start Date: November 2008
Study Completion Date: July 2009
Primary Completion Date: July 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:   up 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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Ronald Litman, DO, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00754897     History of Changes
Other Study ID Numbers: 2008-06-7001
Study First Received: September 16, 2008
Last Updated: September 14, 2009
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

Additional relevant MeSH terms:
Developmental Disabilities
Hernia
Hernia, Inguinal
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on July 24, 2014