Inguinal HerniaNCT00754897
Feasibility Study for PANDAS
An observational study of Inguinal Hernia and Developmental Delay Disorders, run by Children's Hospital of Philadelphia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Inguinal Hernia, Developmental Delay Disorders
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jul 2009
- 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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children less than 1 year of age that have undergone inguinal hernia surgery during the years of 1999-2007, and children who have had inguinal hernia surgery between the ages of 1 and 3 years during the years 1999-2007. We will then do a telephone interview of the parents of these children to determine if there are siblings that are within three years of age and have not had any exposure to anesthetics agents or sedatives before their 3rd birthday.
Who may be able to join
- Males or females age 0 to 1 year.
- Inguinal hernia surgery between 1/1/1999 and 12/31/2007.
- Parental/guardian permission (informed consent).
Who cannot join
- Gestational age < 36 weeks.
- Any history of hospitalization, including neonatal ICU.
- A history of CNS, cardiac, or pulmonary diseases requiring medical treatment.
- History of subsequent surgery or exposure to anesthetics or sedatives at less than 3 years of age.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Feasibility Study for Pediatric NeuroDevelopmental Assessment Study (PANDAS)
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.
Read the 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.
- Conditions
- Inguinal Hernia, Developmental Delay Disorders
- Keywords
- Phone Interview, Anesthesia, Siblings, Inguinal Hernia, Neurologic Examination, Developmental Delay Disorders
- Medical subject headings
- Hernia, Inguinal, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | We will do a database search to identify children less than 1 year of age that have undergone inguinal hernia surgery during the years of 1999-2007, and children who have had inguinal hernia surgery between the ages of 1 and 3 years during the years 1999-2007. We will then do a telephone interview of the parents of these children to determine if there are siblings that are within three years of age and have not have any exposure to anesthetics agents or sedatives before their 3rd birthday. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Anesthesiology Associates, Ltd.
- Investigators
- Ronald Litman, DO, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754897
- Sponsor's protocol ID
- 2008-06-7001
- Status last verified
- Sep 2009
- First submitted
- 16 Sep 2008
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Pediatric NeuroDevelopmental Assessment Study (PANDAS)
- ClinicalTrials.gov ID
- NCT00754897
- Acronym / sponsor ID
- 2008-06-7001
- Conditions
- Inguinal Hernia, Developmental Delay Disorders
- Keywords
- Phone Interview, Anesthesia, Siblings, Inguinal Hernia, Neurologic Examination, Developmental Delay Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Children's Anesthesiology Associates, Ltd.
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 18 Sep 2008 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –We will do a database search to identify children less than 1 year of age that have undergone inguinal hernia surgery during the years of 1999-2007, and children who have had inguinal hernia surgery between the ages of 1 and 3 years during the years 1999-2007. We will then do a telephone interview of the parents of these children to determine if there are siblings that are within three years of age and have not have any exposure to anesthetics agents or sedatives before their 3rd birthday. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children less than 1 year of age that have undergone inguinal hernia surgery during the years of 1999-2007, and children who have had inguinal hernia surgery between the ages of 1 and 3 years during the years 1999-2007. We will then do a telephone interview of the parents of these children to determine if there are siblings that are within three years of age and have not had any exposure to anesthetics agents or sedatives before their 3rd birthday.
Key inclusion criteria (3 listed)
- Males or females age 0 to 1 year.
- Inguinal hernia surgery between 1/1/1999 and 12/31/2007.
- Parental/guardian permission (informed consent).
Key exclusion criteria (5 listed)
- Gestational age < 36 weeks.
- Any history of hospitalization, including neonatal ICU.
- A history of CNS, cardiac, or pulmonary diseases requiring medical treatment.
- History of subsequent surgery or exposure to anesthetics or sedatives at less than 3 years of age.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 6-9 months
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 16 Sep 2009.
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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.
Ronald Litman, DO principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Developmental Delay Disorders, run by Children's Hospital of Philadelphia at 1 site 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 3 inclusion and 5 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 16 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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. (time frame: 6-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2009.