Feasibility Study for PANDAS

Inguinal Hernia Clinical Trial

Official title:

Feasibility Study for Pediatric NeuroDevelopmental Assessment Study (PANDAS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754897
• Other study ID #: 2008-06-7001
• Status: Completed
• Phase: N/A
• First received: September 16, 2008
• Last updated: September 14, 2009
• Start date: November 2008
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Developmental Delay Disorders
• Developmental Disabilities
• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Children's Anesthesiology Associates, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No