Cognition - OtherNCT00881764
PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study
An observational study of Cognition - Other, run by Columbia University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition - Other
- What is being tested?
- Inguinal hernia surgery and General anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 369 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2009to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will be a multi-center study based at Columbia University with the following participating centers: Boston Children's (Harvard University), Children's Hospital of Philadelphia (University of Pennsylvania), Monroe Carell Children's Hospital (Vanderbilt University), and Morgan Stanley Children's Hospital of New York (Columbia University). Children exposed to anesthesia prior to 36 months must be ages 8 yr, 0 mo to 15 yr, 0 mo and have a sibling with no history of surgery or anesthesia prior to 36 months of age.
Who may be able to join
- Exposed cohort:
- Subjects who had inguinal hernia surgery before 36 months of age
- Ages 8 yr, 0 mo to 15 yr, 0 mo
- Gestation age greater or equal to 36 weeks
- Categorized as ASA I or ASA II
- English speaking
Show all 14Show fewer
- Biologically related to the unexposed sibling
- Unexposed cohort:
- Sibling within 36 months of age of the exposed cohort
- Never had surgery or exposure to anesthesia prior to 36 months of age
- Ages 8 yr, 0 mo to 15 yr, 0 mo
- Gestation age greater or equal to 36 weeks
- Categorized as ASA I or ASA II
- 5. English speaking 6. Biologically related to the exposed sibling
Who cannot join
- Exposed cohort:
- Gestational age less than 36 weeks at birth
- No exposure to surgery or anesthesia prior to 36 months of age
- Surgery/Anesthesia other than index hernia repair prior to 36 months of age
- Not categorized as ASA I or ASA II
- Not ages 8 yr, 0 mo to 15 yr, 0 mo
Show all 15Show fewer
- Not English speaking
- Not biologically related to the unexposed sibling
- Unexposed cohort:
- Gestational age under 36 weeks at birth
- Any exposure to surgery or anesthesia prior to 36 months of age
- Not categorized as ASA I or ASA II
- Not ages 8 yr, 0 mo to 15 yr, 0 mo
- Not English speaking
- Not biologically related to the unexposed sibling
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University, 622 W. 168th St.
New York, New York, 10032
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Anesthesia Exposure and Neurodevelopment in Infants and Children: Pediatric Anesthesia & NeuroDevelopment (PANDA) Study
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.
Read the detailed description
The purpose of our study is to compare neurocognitive functions in sibling pairs: one of whom had exposure to anesthesia during surgery before 36 months of age (exposed sibling cohorts) and who would be from ages 8yr, 0 mo to15 yr, 0 mo at the time of the study; and the other who never had anesthesia or surgery less than 36 months of age, is from ages 8yr, 0mo to 15 yr, 0 mo at the time of the study, and is within 36 months of age range from the exposed sibling(unexposed sibling cohort).
Neuropsychological assessments are administered to the sibling cohorts prospectively and parents of the siblings will complete parental interviews/questionnaires. We assess individually neurocognitive, behavioral and emotional function for both exposed and unexposed siblings. Family function will also be evaluated. We will also obtain complete medical history for each participant, including significant perinatal events and social history. We also review medical records when appropriate.
All testing are performed during a one day site visit.
- Conditions
- Cognition - Other
- Being tested
- Inguinal hernia surgery, General anesthesia
- Keywords
- Anesthesia, New York, Columbia, Children, Neurodevelopment, Child development, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal hernia surgeryProcedure or surgery
Non-experimental procedure
General anesthesiaProcedure or surgery
Non-experimental procedure/treatment
| Study group | Role | What they receive |
|---|---|---|
| Exposed Cohort | Children who had inguinal hernia surgery and general anesthesia before 36 months of age (n=500). These children should be ages 8 yr, 0 mo to 15 yr, 0 mo at the time of the study period. Receives: Procedure: Inguinal hernia surgery; Procedure: General anesthesia | |
| Unexposed Cohort | Children who are siblings of the exposed children (inguinal hernia surgery and general anesthesia) and differ in age from the exposed children by less than 36 months and have no history of surgery or exposure to volatile and intravenous anesthetics or sedatives including barbiturates, benzodiazepines and chloral hydrate less than 36 months of age. These children should also be ages 8 yr, 0 mo to 15 yr, 0 mo at the time of the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neurocognitive function
Global cognitive function: verbal, performance and full IQ assessed by Wechsler Abbreviated Scale of Intelligence (WASI). These are one unit of measure for IQ.
Measured: Varies; when the participant is 8-15 years of age
Secondary outcomes (12)
Change in domain-specific function related to visual memory and learning
NEPSY II (A Developmental Neuropsychological Assessment) assesses visual memory learning
Measured: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to verbal memory and learning
California Verbal Learning Test-Children (CVLT-C) assesses verbal memory and learning.
Measured: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to receptive language
NEPSY II (A Developmental Neuropsychological Assessment) is used to assess receptive language and speeded naming.
Measured: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to expressive language
WASI is used to assess expressive language and verbal reasoning
Measured: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to working memory
Weschler Intelligence Scale for Children (WISC-IV) is used to assess working memory, attention and executive function.
Measured: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to all executive function components
Behavior Rating In Executive Function (BRIEF) is used to assess all components of executive function.
Measured: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to selective attention and impulsivity
Continuous Performance Test-II (CPT-II) is used to assess sustained and selective attention as well as impulsivity.
Measured: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to cognitive flexibility aspects of executive function
Delis-Kaplan Executive Function System (DKEFS) is used to assess cognitive flexibility.
Measured: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to motor and processing speed
Grooved pegboard and Weschler Intelligence Scale for Children (WISC-IV) are used to assess motor and processing speed
Measured: Varies; when the participant is 8-15 years of age
Changes in behavior
Childhood Behavior Check List (CBCL) assesses emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems and aggressive behavior.
Measured: Varies; when the participant is 8-15 years of age
Changes in adaptive behavior
Adaptive behavior is assessed using Adaptive Behavior Assessment Systems II (ABAS-II), which measures overall adaptive behavior and skills.
Measured: Varies; when the participant is 8-15 years of age
Changes in parental relationships
Parent Relationship Questionnaire (PRQ) is used to explore parents' perspectives on parent-child relationship.
Measured: Varies; when the participant is 8-15 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cognition - OtherStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions and Grants Services (OAGS)
- Responsible party
- Principal investigator, Lena S. Sun, Columbia University
- Investigators
- Lena S Sun, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881764
- Sponsor's protocol ID
- AAAC8756
- Other IDs
- R34HD060741, HHSF223200810036C, SmartTots
- Status last verified
- Feb 2023
- First submitted
- 14 Apr 2009
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ikonomidou C, Bosch F, Miksa M, Bittigau P, Vockler J, Dikranian K, Tenkova TI, Stefovska V, Turski L, Olney JW. Blockade of NMDA receptors and apoptotic neurodegeneration in the developing brain. Science. 1999 Jan 1;283(5398):70-4. doi: 10.1126/science.283.5398.70.
PubMed 9872743Anand KJ, Soriano SG. Anesthetic agents and the immature brain: are these toxic or therapeutic? Anesthesiology. 2004 Aug;101(2):527-30. doi: 10.1097/00000542-200408000-00033. No abstract available.
PubMed 15277935Anand KJ. Anesthetic neurotoxicity in newborns: should we change clinical practice? Anesthesiology. 2007 Jul;107(1):2-4. doi: 10.1097/01.anes.0000268484.05444.35. No abstract available.
PubMed 17585205Olney JW, Young C, Wozniak DF, Jevtovic-Todorovic V, Ikonomidou C. Do pediatric drugs cause developing neurons to commit suicide? Trends Pharmacol Sci. 2004 Mar;25(3):135-9. doi: 10.1016/j.tips.2004.01.002. No abstract available.
PubMed 15019268Walden M, Carrier CT. Sleeping beauties: the impact of sedation on neonatal development. J Obstet Gynecol Neonatal Nurs. 2003 May-Jun;32(3):393-401. doi: 10.1177/0884217503253454.
PubMed 12774882Mellon RD, Simone AF, Rappaport BA. Use of anesthetic agents in neonates and young children. Anesth Analg. 2007 Mar;104(3):509-20. doi: 10.1213/01.ane.0000255729.96438.b0.
PubMed 17312200Jevtovic-Todorovic V, Hartman RE, Izumi Y, Benshoff ND, Dikranian K, Zorumski CF, Olney JW, Wozniak DF. Early exposure to common anesthetic agents causes widespread neurodegeneration in the developing rat brain and persistent learning deficits. J Neurosci. 2003 Feb 1;23(3):876-82. doi: 10.1523/JNEUROSCI.23-03-00876.2003.
PubMed 12574416Slikker et al. FDA science 2005 Forum
Slikker W Jr, Zou X, Hotchkiss CE, Divine RL, Sadovova N, Twaddle NC, Doerge DR, Scallet AC, Patterson TA, Hanig JP, Paule MG, Wang C. Ketamine-induced neuronal cell death in the perinatal rhesus monkey. Toxicol Sci. 2007 Jul;98(1):145-58. doi: 10.1093/toxsci/kfm084. Epub 2007 Apr 10.
PubMed 17426105Olney at al. FDA symposium. 2002:12:488-498
Jevtovic-Todorovic V. General anesthetics and the developing brain: friends or foes? J Neurosurg Anesthesiol. 2005 Oct;17(4):204-6. doi: 10.1097/01.ana.0000178111.26972.16. No abstract available.
PubMed 16184065
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia Exposure and Neurodevelopment in Infants and Children: Pediatric Anesthesia & NeuroDevelopment (PANDA) Study
- ClinicalTrials.gov ID
- NCT00881764
- Acronym / sponsor ID
- AAAC8756
- Conditions
- Cognition - Other
- Keywords
- Anesthesia, New York, Columbia, Children, Neurodevelopment, Child development, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions and Grants Services (OAGS)
- Study start
- May 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of our study is to compare neurocognitive functions in sibling pairs: one of whom had exposure to anesthesia during surgery before 36 months of age (exposed sibling cohorts) and who would be from ages 8yr, 0 mo to15 yr, 0 mo at the time of the study; and the other who never had anesthesia or surgery less than 36 months of age, is from ages 8yr, 0mo to 15 yr, 0 mo at the time of the study, and is within 36 months of age range from the exposed sibling(unexposed sibling cohort).
Neuropsychological assessments are administered to the sibling cohorts prospectively and parents of the siblings will complete parental interviews/questionnaires. We assess individually neurocognitive, behavioral and emotional function for both exposed and unexposed siblings. Family function will also be evaluated. We will also obtain complete medical history for each participant, including significant perinatal events and social history. We also review medical records when appropriate.
All testing are performed during a one day site visit.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Cohort | – | Procedure: Inguinal hernia surgery, Procedure: General anesthesiaChildren who had inguinal hernia surgery and general anesthesia before 36 months of age (n=500). These children should be ages 8 yr, 0 mo to 15 yr, 0 mo at the time of the study period. |
| Unexposed Cohort | – | –Children who are siblings of the exposed children (inguinal hernia surgery and general anesthesia) and differ in age from the exposed children by less than 36 months and have no history of surgery or exposure to volatile and intravenous anesthetics or sedatives including barbiturates, benzodiazepines and chloral hydrate less than 36 months of age. These children should also be ages 8 yr, 0 mo to 15 yr, 0 mo at the time of the study period. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will be a multi-center study based at Columbia University with the following participating centers: Boston Children's (Harvard University), Children's Hospital of Philadelphia (University of Pennsylvania), Monroe Carell Children's Hospital (Vanderbilt University), and Morgan Stanley Children's Hospital of New York (Columbia University). Children exposed to anesthesia prior to 36 months must be ages 8 yr, 0 mo to 15 yr, 0 mo and have a sibling with no history of surgery or anesthesia prior to 36 months of age.
Key inclusion criteria (14 listed)
- Subjects who had inguinal hernia surgery before 36 months of age
- Ages 8 yr, 0 mo to 15 yr, 0 mo
- Gestation age greater or equal to 36 weeks
- Categorized as ASA I or ASA II
- English speaking
Key exclusion criteria (15 listed)
- Gestational age less than 36 weeks at birth
- No exposure to surgery or anesthesia prior to 36 months of age
- Surgery/Anesthesia other than index hernia repair prior to 36 months of age
- Not categorized as ASA I or ASA II
- Not ages 8 yr, 0 mo to 15 yr, 0 mo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inguinal hernia surgeryNon-experimental procedure | Procedure or surgery | Exposed Cohort |
| General anesthesiaNon-experimental procedure/treatment | Procedure or surgery | Exposed Cohort |
Primary outcome
Change in neurocognitive function
Time frame: Varies; when the participant is 8-15 years of age
Global cognitive function: verbal, performance and full IQ assessed by Wechsler Abbreviated Scale of Intelligence (WASI). These are one unit of measure for IQ.
12 secondary outcomes
Change in domain-specific function related to visual memory and learning
Time frame: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to verbal memory and learning
Time frame: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to receptive language
Time frame: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to expressive language
Time frame: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to working memory
Time frame: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to all executive function components
Time frame: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to selective attention and impulsivity
Time frame: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to cognitive flexibility aspects of executive function
Time frame: Varies; when the participant is 8-15 years of age
Change in domain-specific function related to motor and processing speed
Time frame: Varies; when the participant is 8-15 years of age
Changes in behavior
Time frame: Varies; when the participant is 8-15 years of age
Changes in adaptive behavior
Time frame: Varies; when the participant is 8-15 years of age
Changes in parental relationships
Time frame: Varies; when the participant is 8-15 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Background: PubMed 9872743Ikonomidou C, Bosch F, Miksa M, Bittigau P, Vockler J, Dikranian K, Tenkova TI, Stefovska V, Turski L, Olney JW. Blockade of NMDA receptors and apoptotic neurodegeneration in the developing brain. Science. 1999 Jan 1;283(5398):70-4. doi: 10.1126/science.283.5398.70.
- Background: PubMed 15277935Anand KJ, Soriano SG. Anesthetic agents and the immature brain: are these toxic or therapeutic? Anesthesiology. 2004 Aug;101(2):527-30. doi: 10.1097/00000542-200408000-00033. No abstract available.
- Background: PubMed 17585205Anand KJ. Anesthetic neurotoxicity in newborns: should we change clinical practice? Anesthesiology. 2007 Jul;107(1):2-4. doi: 10.1097/01.anes.0000268484.05444.35. No abstract available.
- Background: PubMed 15019268Olney JW, Young C, Wozniak DF, Jevtovic-Todorovic V, Ikonomidou C. Do pediatric drugs cause developing neurons to commit suicide? Trends Pharmacol Sci. 2004 Mar;25(3):135-9. doi: 10.1016/j.tips.2004.01.002. No abstract available.
- Background: PubMed 12774882Walden M, Carrier CT. Sleeping beauties: the impact of sedation on neonatal development. J Obstet Gynecol Neonatal Nurs. 2003 May-Jun;32(3):393-401. doi: 10.1177/0884217503253454.
- Background: PubMed 17312200Mellon RD, Simone AF, Rappaport BA. Use of anesthetic agents in neonates and young children. Anesth Analg. 2007 Mar;104(3):509-20. doi: 10.1213/01.ane.0000255729.96438.b0.
- Background: PubMed 12574416Jevtovic-Todorovic V, Hartman RE, Izumi Y, Benshoff ND, Dikranian K, Zorumski CF, Olney JW, Wozniak DF. Early exposure to common anesthetic agents causes widespread neurodegeneration in the developing rat brain and persistent learning deficits. J Neurosci. 2003 Feb 1;23(3):876-82. doi: 10.1523/JNEUROSCI.23-03-00876.2003.
- BackgroundSlikker et al. FDA science 2005 Forum
- Background: PubMed 17426105Slikker W Jr, Zou X, Hotchkiss CE, Divine RL, Sadovova N, Twaddle NC, Doerge DR, Scallet AC, Patterson TA, Hanig JP, Paule MG, Wang C. Ketamine-induced neuronal cell death in the perinatal rhesus monkey. Toxicol Sci. 2007 Jul;98(1):145-58. doi: 10.1093/toxsci/kfm084. Epub 2007 Apr 10.
- BackgroundOlney at al. FDA symposium. 2002:12:488-498
- Background: PubMed 16184065Jevtovic-Todorovic V. General anesthetics and the developing brain: friends or foes? J Neurosurg Anesthesiol. 2005 Oct;17(4):204-6. doi: 10.1097/01.ana.0000178111.26972.16. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena S Sun, MD principal investigator
Columbia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition - Other, run by Columbia University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neurocognitive function (time frame: Varies; when the participant is 8-15 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00881764, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.