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PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study

NCT00881764 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 369

Last updated 2023-02-17

No results posted yet for this study

Summary

The purpose of this study is to determine whether the use of anesthetic agents in infants and children have long term adverse effects on neurocognitive development. According to the National Hospital Discharge Survey, around 2.5 million children have surgical procedures requiring anesthesia each year in the US. Recent animal studies have suggested that the exposure of the immature organism to a variety of commonly used anesthetic agents may lead to neurobehavioral functional deficits in vivo and to neuronal apoptosis in vitro. While the relevance of these findings on children exposed to anesthetics remains to be determined, it is clearly critically important to public health that this issue is resolved quickly and clearly.

Hypothesis: Exposure to anesthetic agents within the first three years of life will not significantly impair cognitive functions at ages 8 yr, 0 mo to 15 yr, 0 mo.

Conditions

  • Cognition - Other

Interventions

PROCEDURE

Inguinal hernia surgery

Non-experimental procedure

PROCEDURE

General anesthesia

Non-experimental procedure/treatment

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Office of Acquisitions and Grants Services (OAGS)

    collaborator UNKNOWN

  • Columbia University

    lead OTHER

Principal Investigators

  • Lena S Sun, MD · Columbia University

Eligibility

Min Age
8 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2015-04-30
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00881764 on ClinicalTrials.gov