Skip to content

Feasibility Study for PANDAS

Feasibility Study for Pediatric NeuroDevelopmental Assessment Study (PANDAS)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00754897
Enrollment
72
Registered
2008-09-18
Start date
2008-11-30
Completion date
2009-07-31
Last updated
2009-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Delay Disorders, Inguinal Hernia

Keywords

Phone Interview, Anesthesia, Siblings, Inguinal Hernia, Neurologic Examination, Developmental Delay Disorders

Brief 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.

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.

Interventions

None listed

Sponsors

Children's Anesthesiology Associates, Ltd.
CollaboratorOTHER
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026