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Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study

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ClinicalTrials.gov Identifier: NCT02789176
Recruitment Status : Completed
First Posted : June 2, 2016
Results First Posted : November 5, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
University of California, San Francisco
Boston Children's Hospital
Children's Hospital of Philadelphia
Children's National Research Institute
Massachusetts General Hospital
Patient-Centered Outcomes Research Institute
Stanford University
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Duke University
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Renée Shellhaas, MD, University of Michigan

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Neonatal Seizures
Interventions Other: Surveys
Other: EEG
Enrollment 303
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Outpatient Enrollees - Maintain Anti-Seizure Medicine Outpatient Enrollees- Discontinue Anti-Seizure Medicine Inpatient Enrollees - Maintain Anti-Seizure Medicine Inpatient Enrollees - Discontinue Anti-Seizure Medicine
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 99 55 95 54
Completed 91 53 85 53
Not Completed 8 2 10 1
Reason Not Completed
Death             0             0             3             0
Withdrawal by Subject             0             0             1             0
Lost to Follow-up             8             2             6             1
Arm/Group Title Outpatient Enrollees - Maintatin Anti-Seizure Medicine Outpatient Enrollees - Discontinue Anti-Seizure Medicine Inpatient Enrollees - Maintain Anti-Seizure Medicine Inpatient Enrollees - Discontinue Anti-Seizure Medicine Total
Hide Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 99 55 95 54 303
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 92 participants 53 participants 79 participants 49 participants 273 participants
23.89  (0.76) 23.94  (0.76) 23.65  (0.56) 23.97  (0.76) 23.84  (0.72)
[1]
Measure Analysis Population Description: Not all subjects completed all the time points and survey questions. Therefore, the number analyzed in the rows may vary.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 55 participants 95 participants 54 participants 303 participants
Female
47
  47.5%
26
  47.3%
36
  37.9%
24
  44.4%
133
  43.9%
Male
52
  52.5%
29
  52.7%
59
  62.1%
30
  55.6%
170
  56.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 55 participants 95 participants 54 participants 303 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.1%
1
   1.9%
2
   0.7%
Asian
6
   6.1%
3
   5.5%
5
   5.3%
6
  11.1%
20
   6.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
2
   2.1%
0
   0.0%
2
   0.7%
Black or African American
12
  12.1%
11
  20.0%
7
   7.4%
6
  11.1%
36
  11.9%
White
69
  69.7%
36
  65.5%
59
  62.1%
28
  51.9%
192
  63.4%
More than one race
5
   5.1%
0
   0.0%
3
   3.2%
2
   3.7%
10
   3.3%
Unknown or Not Reported
7
   7.1%
5
   9.1%
18
  18.9%
11
  20.4%
41
  13.5%
1.Primary Outcome
Title WIDEA Neurodevelopmental Outcome Score
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Outpatient Enrollees - Maintain Anti-Seizure Medicine Outpatient Enrollees - Discontinue Anti-Seizure Medicine Inpatient Enrollees - Maintain Anti-Seizure Medicine Inpatient Enrollees - Discontinue Anti-Seizure Medicine
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 90 52 79 49
Mean (Standard Deviation)
Unit of Measure: score on a scale
149.04  (34.55) 162.46  (25.94) 148.80  (33.52) 151.89  (33.24)
2.Primary Outcome
Title Number of Participants With Post-neonatal Epilepsy
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Outpatient Enrollees - Maintain Anti-Seizure Medicine Outpatient Enrollees - Discontinue Anti-Seizure Medicine Inpatient Enrollees - Maintain Anti-Seizure Medicine Inpatient Enrollees - Discontinue Anti-Seizure Medicine
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 90 53 85 53
Measure Type: Count of Participants
Unit of Measure: Participants
14
  15.6%
2
   3.8%
11
  12.9%
10
  18.9%
3.Secondary Outcome
Title Length of Stay for the Neonatal Seizure Admission
Hide Description 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)
Time Frame length of stay, measured in days, will be recorded during a chart review when the child is 12 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Outpatient Enrollees - Maintain Anti-Seizure Medicine Outpatient Enrollees - Discontinue Anti-Seizure Medicine Inpatient Enrollees - Maintain Anti-Seizure Medicine Inpatient Enrollees - Discontinue Anti-Seizure Medicine
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 91 53 85 53
Median (Inter-Quartile Range)
Unit of Measure: number of days
15
(10 to 25)
11
(7 to 19)
17
(9 to 37)
15
(9 to 31)
4.Secondary Outcome
Title Impact of Treatment Duration on Parent and Family Well-being
Hide Description 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).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not all subjects completed every survey question, therefore some rows have different participants for the various outcome measures.
Arm/Group Title Outpatient Enrollees - Maintain Anti-Seizure Medicine Outpatient Enrollees - Discontinue Anti-Seizure Medicine Inpatient Enrollees - Maintain Anti-Seizure Medicine Inpatient Enrollees - Discontinue Anti-Seizure Medicine
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 82 50 70 43
Mean (Standard Deviation)
Unit of Measure: score on a scale
24 month HADS Depression Score Number Analyzed 82 participants 50 participants 70 participants 43 participants
3.44  (3.01) 2.92  (2.61) 3.17  (2.97) 3.72  (4.04)
24 month HADS Anxiety Score Number Analyzed 82 participants 50 participants 70 participants 43 participants
6.15  (4.20) 5.30  (3.81) 5.83  (3.79) 6.84  (4.89)
24 month Transformed WHO Overall Quality of Life Score Number Analyzed 80 participants 50 participants 60 participants 39 participants
76.09  (18.14) 78.00  (16.67) 76.67  (17.75) 75.32  (20.97)
24 month Impact on Family Scale overall impact scale, 24 mo Number Analyzed 81 participants 50 participants 70 participants 43 participants
28.78  (10.41) 25.50  (9.26) 28.30  (10.31) 28.88  (11.42)
24 month Post Traumatic Growth Inventory Number Analyzed 82 participants 50 participants 70 participants 43 participants
59.5  (25.1) 61.9  (25.3) 61.7  (27.0) 62.7  (25.0)
24 month Impact of Events Scale Number Analyzed 82 participants 50 participants 70 participants 43 participants
15.1  (15.0) 14.7  (13.6) 13.8  (13.9) 16.3  (15.0)
Time Frame 24 months
Adverse Event Reporting Description 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.
 
Arm/Group Title Outpatient Enrollees - Maintain Anti-Seizure Medicine Outpatient Enrollees - Discontinue Anti-Seizure Medicine Inpatient Enrollees - Maintain Anti-Seizure Medicine Inpatient Enrollees -Discontinue Anti-Seizure Medicine
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Outpatient Enrollees - Maintain Anti-Seizure Medicine Outpatient Enrollees - Discontinue Anti-Seizure Medicine Inpatient Enrollees - Maintain Anti-Seizure Medicine Inpatient Enrollees -Discontinue Anti-Seizure Medicine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)   0/55 (0.00%)   3/95 (3.16%)   0/54 (0.00%) 
Hide Serious Adverse Events
Outpatient Enrollees - Maintain Anti-Seizure Medicine Outpatient Enrollees - Discontinue Anti-Seizure Medicine Inpatient Enrollees - Maintain Anti-Seizure Medicine Inpatient Enrollees -Discontinue Anti-Seizure Medicine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)   0/55 (0.00%)   0/95 (0.00%)   0/54 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Outpatient Enrollees - Maintain Anti-Seizure Medicine Outpatient Enrollees - Discontinue Anti-Seizure Medicine Inpatient Enrollees - Maintain Anti-Seizure Medicine Inpatient Enrollees -Discontinue Anti-Seizure Medicine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)   0/55 (0.00%)   0/95 (0.00%)   0/54 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephanie Rau
Organization: University of Michigan
Phone: 734-232-8474
EMail: shatchew@med.umich.edu
Layout table for additonal information
Responsible Party: Renée Shellhaas, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT02789176    
Other Study ID Numbers: HUM00114541
1507-31187 ( Other Identifier: PCORI project number )
First Submitted: May 19, 2016
First Posted: June 2, 2016
Results First Submitted: October 13, 2020
Results First Posted: November 5, 2020
Last Update Posted: December 4, 2020