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| ID | Type | Description | Link |
|---|---|---|---|
| 1507-31187 | Other Identifier | PCORI project number |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Boston Children's Hospital | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Children's National Research Institute |
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The purpose of this study is to examine whether the duration of treatment with phenobarbital has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family well-being, after neonatal seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient Enrollees | This is a cohort of 150 subjects who were previously enrolled in the Neonatal Seizure Registry, a multi-center association of institutions across the United States, They were contacted to participate in the study after discharge from the Neonatal Intensive Care Unit (NICU) but prior to the prospective follow up. They were asked to take part in all prospective follow up surveys at 12, 18, & 24 months of age. |
| |
| NICU Enrollees | This is a cohort of 150 subjects who were enrolled in the study prior to discharge from the NICU. They were asked to complete surveys prior to discharge from the NICU, returned to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, & completed the follow surveys at 12, 18, & 24 months of age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveys | Other | Regarding development, epilepsy, and family impact |
|
| Measure | Description | Time Frame |
|---|---|---|
| WIDEA Neurodevelopmental Outcome Score | The Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA FS) allowed us to compare the functional development between newborns who received short duration phenobarbital treatment and prolonged phenobarbital treatment. There were 50 questions with response options of 1(Never) to 4(all the time). WIDEA range was on a scale from 50-200 (At 24 months, the normal population mean score is 172±10).The higher the score the better the child's developmental function. Mean scores were calculated using data from any participant who completed surveys at 24 months. | 24 months |
| Number of Participants With Post-neonatal Epilepsy | The diagnosis of epilepsy and the details of seizure types and frequencies were determined by telephone interview with the parent and corroborated by medical record review. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay for the Neonatal Seizure Admission | Evaluation of medication exposure (dose and duration) during the admission as a predictor of the number of days the infant requires care (length of stay) | length of stay, measured in days, will be recorded during a chart review when the child is 12 months of age |
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Inclusion Criteria:
Exclusion Criteria:
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Newborns with seizures who were admitted at one of the participating children's hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Renée A Shellhaas, MD, MS | University of Michigan | Principal Investigator |
| Hannah C Glass, MDCM, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32446494 | Derived | Franck LS, Shellhaas RA, Lemmon M, Sturza J, Soul JS, Chang T, Wusthoff CJ, Chu CJ, Massey SL, Abend NS, Thomas C, Rogers EE, McCulloch CE, Grant K, Grossbauer L, Pawlowski K, Glass HC; Neonatal Seizure Registry study group. Associations between Infant and Parent Characteristics and Measures of Family Well-Being in Neonates with Seizures: A Cohort Study. J Pediatr. 2020 Jun;221:64-71.e4. doi: 10.1016/j.jpeds.2020.02.024. |
| Label | URL |
|---|---|
| PCORI website | View source |
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Will be posted on pcori.org
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| ID | Title | Description |
|---|---|---|
| FG000 | Outpatient Enrollees - Maintain Anti-Seizure Medicine | This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) on anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2020 |
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| OTHER |
| Massachusetts General Hospital | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
| Stanford University | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
| Duke University | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
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| EEG | Other |
|
| Impact of Treatment Duration on Parent and Family Well-being |
Surveys selected with the help of our Parent Partners were given at 12, 18, and 24 months to assess the impact of neonatal seizure treatment duration on parent and family quality of life and well-being. The 24 month data is presented, as they align with the primary outcome. The study team reviewed the HADS 24 month Anxiety and Depression Score range of possible scores from 0-21 (higher = more depressed/more anxious), the 24 month Transformed WHO Overall Quality of Life and General Health score range of scores 0-100 (higher=better quality of life), the 24 month Impact on Family Scale overall impact scale range from 15-60 (higher = more impact on family), the 24 month Post Traumatic Growth Inventory scale range from 0 -105 (higher = better/more growth), and the 24 month Impact of Events Scale-Revised scale range from 0 - 88 (higher score = worse impact). |
| 24 months |
| Stanford |
| California |
| 94304 |
| United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Duke University | Durham | North Carolina | 227710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| FG001 | Outpatient Enrollees- Discontinue Anti-Seizure Medicine | This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) off anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age. |
| FG002 | Inpatient Enrollees - Maintain Anti-Seizure Medicine | This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged on anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. |
| FG003 | Inpatient Enrollees - Discontinue Anti-Seizure Medicine | This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged off anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Outpatient Enrollees - Maintatin Anti-Seizure Medicine | This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) on anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age. |
| BG001 | Outpatient Enrollees - Discontinue Anti-Seizure Medicine | This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) off anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age. |
| BG002 | Inpatient Enrollees - Maintain Anti-Seizure Medicine | This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged on anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. |
| BG003 | Inpatient Enrollees - Discontinue Anti-Seizure Medicine | This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged off anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Not all subjects completed all the time points and survey questions. Therefore, the number analyzed in the rows may vary. | Mean | Standard Deviation | Months |
| |||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | WIDEA Neurodevelopmental Outcome Score | The Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA FS) allowed us to compare the functional development between newborns who received short duration phenobarbital treatment and prolonged phenobarbital treatment. There were 50 questions with response options of 1(Never) to 4(all the time). WIDEA range was on a scale from 50-200 (At 24 months, the normal population mean score is 172±10).The higher the score the better the child's developmental function. Mean scores were calculated using data from any participant who completed surveys at 24 months. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Post-neonatal Epilepsy | The diagnosis of epilepsy and the details of seizure types and frequencies were determined by telephone interview with the parent and corroborated by medical record review. | Participants analyzed reflect the number of participants who completed the 24 month follow-up survey. Also one participant did not have data for epilepsy diagnosis | Posted | Count of Participants | Participants | 24 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Length of Stay for the Neonatal Seizure Admission | Evaluation of medication exposure (dose and duration) during the admission as a predictor of the number of days the infant requires care (length of stay) | Posted | Median | Inter-Quartile Range | number of days | length of stay, measured in days, will be recorded during a chart review when the child is 12 months of age |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Impact of Treatment Duration on Parent and Family Well-being | Surveys selected with the help of our Parent Partners were given at 12, 18, and 24 months to assess the impact of neonatal seizure treatment duration on parent and family quality of life and well-being. The 24 month data is presented, as they align with the primary outcome. The study team reviewed the HADS 24 month Anxiety and Depression Score range of possible scores from 0-21 (higher = more depressed/more anxious), the 24 month Transformed WHO Overall Quality of Life and General Health score range of scores 0-100 (higher=better quality of life), the 24 month Impact on Family Scale overall impact scale range from 15-60 (higher = more impact on family), the 24 month Post Traumatic Growth Inventory scale range from 0 -105 (higher = better/more growth), and the 24 month Impact of Events Scale-Revised scale range from 0 - 88 (higher score = worse impact). | Not all subjects completed every survey question, therefore some rows have different participants for the various outcome measures. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
24 months
This was an observational study. No intervention was assigned based on participation in the study. All-cause mortality is reported but deaths cannot be attributed to study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Outpatient Enrollees - Maintain Anti-Seizure Medicine | This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) on anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age. | 0 | 99 | 0 | 99 | 0 | 99 |
| EG001 | Outpatient Enrollees - Discontinue Anti-Seizure Medicine | This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) off anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age. | 0 | 55 | 0 | 55 | 0 | 55 |
| EG002 | Inpatient Enrollees - Maintain Anti-Seizure Medicine | This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged on anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. | 3 | 95 | 0 | 95 | 0 | 95 |
| EG003 | Inpatient Enrollees -Discontinue Anti-Seizure Medicine | This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged off anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. | 0 | 54 | 0 | 54 | 0 | 54 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Rau | University of Michigan | 734-232-8474 | shatchew@med.umich.edu |
| Sep 20, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged on anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. |
| OG003 | Inpatient Enrollees - Discontinue Anti-Seizure Medicine | This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged off anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. |
|
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| OG003 | Inpatient Enrollees - Discontinue Anti-Seizure Medicine | This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged off anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. |
|
|
This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) off anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age. |
| OG002 | Inpatient Enrollees - Maintain Anti-Seizure Medicine | This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged on anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. |
| OG003 | Inpatient Enrollees - Discontinue Anti-Seizure Medicine | This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged off anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age. |
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