Neonatal SeizuresNCT02789176
Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
An observational study of Neonatal Seizures, run by University of Michigan at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 weeks to 24 months
- Conditions the study is for
- Neonatal Seizures
- What is being tested?
- Surveys and EEG
- How many people
- 303 participants
- Where
- 11 sitesUnited States
- Study dates
- Oct 2016to 24 Mar 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Newborns with seizures who were admitted at one of the participating children's hospitals
Who may be able to join
- Neonates <44 weeks corrected age at seizure onset
- Seizures due to acute brain injury
- Parent(s) who are English or Spanish literate (with assistance of interpreter)
Who cannot join
- Neonates at risk for adverse outcome independent of seizures and underlying brain injury
- Neonates with mild, temporary causes for seizures
- Newborns with neonatal-onset epilepsy syndromes
- Neonates who do not survive the initial hospital admission
- Neonates will not be excluded based on race, ethnicity, gender or gestational age
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University
Durham, North Carolina, 227710
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California, San Francisco
San Francisco, California, 94143
Stanford University
Stanford, California, 94304
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
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.
- Conditions
- Neonatal Seizures
- Being tested
- Surveys, EEG
- Keywords
- Phenobarbital, EEG, family impact, neurodevelopment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Also called Former Neonatal Seizure Registry Subjects
Regarding development, epilepsy, and family impact
EEGOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Surveys | |
| 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. Receives: Other: Surveys; Other: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
Secondary outcomes (2)
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)
Measured: length of stay, measured in days, will be recorded during a chart review when the child is 12 months of age
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).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startOct 2016
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal SeizuresStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Renée Shellhaas, MD, University of Michigan
- Investigators
- Renée A Shellhaas, MD, MS, Principal investigator, University of MichiganHannah C Glass, MDCM, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789176
- Sponsor's protocol ID
- HUM00114541
- Other IDs
- 1507-31187
- Status last verified
- Nov 2020
- First submitted
- 19 May 2016
- Last updated
- 4 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Will be posted on pcori.org
Publications
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.
PubMed 32446494
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
- ClinicalTrials.gov ID
- NCT02789176
- Acronym / sponsor ID
- HUM00114541
- Conditions
- Neonatal Seizures
- Keywords
- Phenobarbital, EEG, family impact, neurodevelopment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- 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
- Study start
- Oct 2016
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Posted 5 Nov 2020
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient Enrollees | – | Other: SurveysThis 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 | – | Other: Surveys, Other: EEGThis 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. |
Who may qualify
- Ages
- 0 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns with seizures who were admitted at one of the participating children's hospitals
Key inclusion criteria (3 listed)
- Neonates <44 weeks corrected age at seizure onset
- Seizures due to acute brain injury
- Parent(s) who are English or Spanish literate (with assistance of interpreter)
Key exclusion criteria (5 listed)
- Neonates at risk for adverse outcome independent of seizures and underlying brain injury
- Neonates with mild, temporary causes for seizures
- Newborns with neonatal-onset epilepsy syndromes
- Neonates who do not survive the initial hospital admission
- Neonates will not be excluded based on race, ethnicity, gender or gestational age
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 |
|---|---|---|
| SurveysAlso: Former Neonatal Seizure Registry SubjectsRegarding development, epilepsy, and family impact | Other | NICU Enrollees, Outpatient Enrollees |
| EEG | Other | NICU Enrollees |
Primary outcome
WIDEA Neurodevelopmental Outcome Score
Time frame: 24 months
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.
Number of Participants With Post-neonatal Epilepsy
Time frame: 24 months
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.
2 secondary outcomes
Length of Stay for the Neonatal Seizure Admission
Time frame: length of stay, measured in days, will be recorded during a chart review when the child is 12 months of age
Impact of Treatment Duration on Parent and Family Well-being
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32446494Franck 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.
- PCORI websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Will be posted on pcori.org
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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.
Renée A Shellhaas, MD, MS principal investigator
University of Michigan
Hannah C Glass, MDCM, MAS principal investigator
University of California, San Francisco
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Seizures, run by University of Michigan at 11 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 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 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Yes. Results are posted in the registry (first posted 5 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
WIDEA Neurodevelopmental Outcome Score (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT02789176, which also lists 1 linked publication.
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 4 Dec 2020.