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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00754897
Other study ID # 2008-06-7001
Secondary ID
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


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
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