Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278961
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-19
Brief Title:
Families Filming Infants Learning Movement
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
The Ontogeny of Fidgety Movements in Infants At High-Risk of Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FILM
Brief Summary:
The study objective is to improve accuracy in the early detection of neurodevelopmental impairment especially CP by evaluating the timepoint in weeks post term age that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity The study team plans to recruit 100 healthy term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants
Detailed Description:
Research teams at Northwestern Prentice University of Sydney Fondazione IRCCS Stella Maris Cerebral Palsy Alliance CPA and Murdoch Childrens Research Institute MCRI will be collecting data in the same manner using the Baby Moves app with the inclusion and exclusion criteria above The data from the Baby Moves app will be temporarily stored in a common REDcap database at the Murdoch Childrens Research Institute MCRI with all sites included The MCRI has all necessary approvals in place to host the videos Video files from Prentice and Lurie will be transferred to a common REDCap Database at Northwestern Other sites University of Sydney MCRI Stella Maris CPA will have their own REDCap databases where the data is stored and managed The research teams at these sites will be responsible for recruiting and consenting subjects All sites except Prentice will seek IRB approval from their respective sites
Study design Prospectively recruited cohort study
Study procedures
Eligible families will be identified using the Electronic Data Warehouse Prentice through Data Analytics and Reporting DAR Lurie the electronic medical record platform EPIC or through recruitment on social media websites and family advocacy websites Families will be contacted via email andor text message and will have the option to enroll through electronic consent econsent in order to minimize in-person contact Participating families will be able to enroll online using REDCap If the family has questions about enrollment or the consent form they will be able to notify a member of the study team using a survey form on REDCap A member of the research team can contact the family by phone to provide information and answer questions about participating in the study Participating families will then receive directions on the phone on how to use and download the Baby Moves app on their smartphones
Participating families will download the Baby Moves app on their smartphones after enrollment A member of the research team will register the infant into the study database using a study ID infant birth date and infant due date The participating families may watch a 3-minute demonstration video on use of the app and proper filming technique
A member of the research team will also record the subjects pertinent medical information neurological findings gestational age at birth birthweight and neonatal medical complications severity of ROP and treatment for ROP if SMA SMA type SMN2 copy number if known date of dx and pharmacologic treatment treatment for SMA and date of 1st treatment into a REDcap database
Parents will receive a reminder on their smartphone through both e-mail and push notification at required filming time points 10 12 14 16 18 and 20 weeks of corrected age Families will be reminded to film the infant Parents will receive the following family-friendly and standardized instructions for filming the baby
All participants will be asked to upload video recordings using the Baby Moves app outside of their standard of care
Infant videos will be uploaded into a HIPAA-compliant REDcap database and the research team will be notified when the family has taken the video using the app
Two advanced-trained general movement assessors will independently review the video within 3-5 days of receiving it using Prechtl methodology see below These assessors will be part of the study team from any of the participating sites but will be blinded to infant data and PHI
General Movement Assessment General movements are a developmentally regulated pattern of spontaneous motor activity appearing in the embryo by 9 weeks post-conceptional age By 50-55 weeks post-conceptional age 10-15 weeks post-term the predominant general movements seen are termed Fidgety Movements - a pattern of continuous small amplitude movements of the neck trunk and limbs during wakefulness that disappear with agitation These patterns are identifiable and are classified as normal if present intermittent or continual and abnormal if exaggerated with respect to speed and amplitude sporadic interspersed with long pauses or absent Importantly absence of these fidgety movements at 10-15 weeks post-term accurately predicts the development of cerebral palsy4 Certified raters will use the 3-minute video filmed by families using the Baby Moves app to categorize infant general movements according to the Prechtl methodology5 and to quantify movement patterns
The family will be notified of the results within one week of uploading the final video at 20 weeks corrected age
If the videos are deemed by raters to be normal the family will receive notification by email
If the infants general movements are deemed to be high-risk the participating family will receive a phone call and will be scheduled for a follow-up visit either as an outpatient or in their home
The families will not receive a formal diagnosis but will be triaged to a virtual visit from a physician or physical therapist At this time they will receive 2 standardized developmental assessments the Alberta Infant Motor Scale AIMS and a modified version of the Hammersmith Infant Neurological Examination HINE These videos will be completed using the videoconferencing software Zoom hosted through The study team will use the waiting room feature to minimize loss of confidentiality risk The files from these encounters will be stored in FSM resfiles andor on encrypted devices
Infants with high-risk general movements will also be referred to local Early Intervention Services
For the very few cases of enrolled participants who take videos from Prentice Womens Hospital or Lurie Childrens Hospital and who are deemed high-risk we will share the risk level based on the studys screening with a clinician in charge of developmental care such as Dr Raye-Anne deRegnier who also happens to be a co-investigator on this study We can communicate with the clinical care team so that the team can accurately and unambiguously share the participants study screening results with the family In this special case we will send a follow up email to families thanking them for participating and letting the families know that we have shared the result with the developmental team at their respective Hospital
Video data from the Baby Moves app will be securely stored in the REDCap database
Duration of the Study Infants will be followed for 5 years Data will be collected until the target of 450 subjects is achieved for all sites
For follow-up the infants will be grouped into two categories
1 Children who are enrolled in a high-risk follow-up clinic
2 Children who are not enrolled in a high-risk follow-up clinic
Infants in group 1 enrolled in high-risk follow-up clinic Infants from all sites who are already enrolled in a high-risk follow-up clinic will be followed for five years using site-specific standardized neurodevelopmental outcome measures which are routinely done in their respective follow-up clinics If enrolled in an SMA follow up clinic a similar follow up protocol will take place using site specific SMA motor function outcome measures which are routinely done in their respective follow-up clinics Data will be collected from standard visit data and entered into REDCap
Infants in group 2 Will be asked to complete surveys at 1 and 2 years of corrected age called the Ages and Stages questionnaire They will send this survey back electronically or by mail
The difference between groups 1 and 2 is that group 1 will not be asked to complete the Ages and Stages questionnaires at 1 and 2 years of age
All families from groups 1 and 2 will fill out a survey about the Baby Moves app that will be completed electronically Each questionnaire will take approximately 5-15 minutes to complete Infants from all sites may also receive follow-up phone calls that will be completed by the parents at 12 and 24 months These phone surveys will require 1-3 minutes of the parents time
Data including names addresses names dates telephone numbers addresses email infants medical history video data questionnaire results and neurodevelopmental tests will be collected prospectively
Researchers from all sites will have access to the REDcap database This REDCap database will be managed by Northwestern University Data use agreements are being established among sites
Additionally individual expert raters in the general movement assessment from additional institutions working as content experts will also have access to de-identified and coded data
While they will not have personal health identifiers these raters will be able to see the face of the infants in the videos The facial expressions and movements of these infants are required in rating the videos The observation of faces are not considered to be identifiers due to the young age of the subjects and their quickly changing appearance
ONE YEAR FOLLOW-UP Infants recruited will receive a one-year-old birthday card from the study team and their families will complete a 12-month Ages and Stages Questionnaire at their childs 12 month corrected age as a global developmental screening with a member of the study team
TWO-YEAR FOLLOW-UP NEURODEVELOPMENTAL ASSESSMENTS Participating families will return for a two-year follow-up visit and will receive the following batteries of standardized assessments
Table 1 Two-year neurodevelopmental assessment battery
Assessment name
Assessment requirements
Constructs assessed
Bayley Scales of Infant and Toddler Development version 4 Bayley-4
Trained assessor standardized test kit with manipulatives stimulus book manual
Cognitive language motor skills norm-referenced
Infant Toddler Quality of Life Questionnaire ITQOL
Parent questionnaire
Quality of Life
Child Behavior Checklist CBCL
Parent questionnaire
Socioemotional
Gross motor functional measure GMFM-66
Trained assessor manual standardized equipment
Motor ability in children diagnosed with cerebral palsy
Only infants diagnosed with CP will be tested with the GMFM-66
We will also record whether a child has received a diagnosis of CP If they have not received a diagnosis but have high-risk based on two-year presentation we will refer patients for diagnostic follow-up and then record outcome of that diagnosis
Study design Prospectively recruited cohort study
Study procedures
Eligible families will be identified using the Electronic Data Warehouse Prentice through Data Analytics and Reporting DAR Lurie the electronic medical record platform EPIC or through recruitment on social media websites and family advocacy websites Families will be contacted via email andor text message and will have the option to enroll through electronic consent econsent in order to minimize in-person contact Participating families will be able to enroll online using REDCap If the family has questions about enrollment or the consent form they will be able to notify a member of the study team using a survey form on REDCap A member of the research team can contact the family by phone to provide information and answer questions about participating in the study Participating families will then receive directions on the phone on how to use and download the Baby Moves app on their smartphones
Participating families will download the Baby Moves app on their smartphones after enrollment A member of the research team will register the infant into the study database using a study ID infant birth date and infant due date The participating families may watch a 3-minute demonstration video on use of the app and proper filming technique
A member of the research team will also record the subjects pertinent medical information neurological findings gestational age at birth birthweight and neonatal medical complications severity of ROP and treatment for ROP if SMA SMA type SMN2 copy number if known date of dx and pharmacologic treatment treatment for SMA and date of 1st treatment into a REDcap database
Parents will receive a reminder on their smartphone through both e-mail and push notification at required filming time points 10 12 14 16 18 and 20 weeks of corrected age Families will be reminded to film the infant Parents will receive the following family-friendly and standardized instructions for filming the baby
All participants will be asked to upload video recordings using the Baby Moves app outside of their standard of care
Infant videos will be uploaded into a HIPAA-compliant REDcap database and the research team will be notified when the family has taken the video using the app
Two advanced-trained general movement assessors will independently review the video within 3-5 days of receiving it using Prechtl methodology see below These assessors will be part of the study team from any of the participating sites but will be blinded to infant data and PHI
General Movement Assessment General movements are a developmentally regulated pattern of spontaneous motor activity appearing in the embryo by 9 weeks post-conceptional age By 50-55 weeks post-conceptional age 10-15 weeks post-term the predominant general movements seen are termed Fidgety Movements - a pattern of continuous small amplitude movements of the neck trunk and limbs during wakefulness that disappear with agitation These patterns are identifiable and are classified as normal if present intermittent or continual and abnormal if exaggerated with respect to speed and amplitude sporadic interspersed with long pauses or absent Importantly absence of these fidgety movements at 10-15 weeks post-term accurately predicts the development of cerebral palsy4 Certified raters will use the 3-minute video filmed by families using the Baby Moves app to categorize infant general movements according to the Prechtl methodology5 and to quantify movement patterns
The family will be notified of the results within one week of uploading the final video at 20 weeks corrected age
If the videos are deemed by raters to be normal the family will receive notification by email
If the infants general movements are deemed to be high-risk the participating family will receive a phone call and will be scheduled for a follow-up visit either as an outpatient or in their home
The families will not receive a formal diagnosis but will be triaged to a virtual visit from a physician or physical therapist At this time they will receive 2 standardized developmental assessments the Alberta Infant Motor Scale AIMS and a modified version of the Hammersmith Infant Neurological Examination HINE These videos will be completed using the videoconferencing software Zoom hosted through The study team will use the waiting room feature to minimize loss of confidentiality risk The files from these encounters will be stored in FSM resfiles andor on encrypted devices
Infants with high-risk general movements will also be referred to local Early Intervention Services
For the very few cases of enrolled participants who take videos from Prentice Womens Hospital or Lurie Childrens Hospital and who are deemed high-risk we will share the risk level based on the studys screening with a clinician in charge of developmental care such as Dr Raye-Anne deRegnier who also happens to be a co-investigator on this study We can communicate with the clinical care team so that the team can accurately and unambiguously share the participants study screening results with the family In this special case we will send a follow up email to families thanking them for participating and letting the families know that we have shared the result with the developmental team at their respective Hospital
Video data from the Baby Moves app will be securely stored in the REDCap database
Duration of the Study Infants will be followed for 5 years Data will be collected until the target of 450 subjects is achieved for all sites
For follow-up the infants will be grouped into two categories
1 Children who are enrolled in a high-risk follow-up clinic
2 Children who are not enrolled in a high-risk follow-up clinic
Infants in group 1 enrolled in high-risk follow-up clinic Infants from all sites who are already enrolled in a high-risk follow-up clinic will be followed for five years using site-specific standardized neurodevelopmental outcome measures which are routinely done in their respective follow-up clinics If enrolled in an SMA follow up clinic a similar follow up protocol will take place using site specific SMA motor function outcome measures which are routinely done in their respective follow-up clinics Data will be collected from standard visit data and entered into REDCap
Infants in group 2 Will be asked to complete surveys at 1 and 2 years of corrected age called the Ages and Stages questionnaire They will send this survey back electronically or by mail
The difference between groups 1 and 2 is that group 1 will not be asked to complete the Ages and Stages questionnaires at 1 and 2 years of age
All families from groups 1 and 2 will fill out a survey about the Baby Moves app that will be completed electronically Each questionnaire will take approximately 5-15 minutes to complete Infants from all sites may also receive follow-up phone calls that will be completed by the parents at 12 and 24 months These phone surveys will require 1-3 minutes of the parents time
Data including names addresses names dates telephone numbers addresses email infants medical history video data questionnaire results and neurodevelopmental tests will be collected prospectively
Researchers from all sites will have access to the REDcap database This REDCap database will be managed by Northwestern University Data use agreements are being established among sites
Additionally individual expert raters in the general movement assessment from additional institutions working as content experts will also have access to de-identified and coded data
While they will not have personal health identifiers these raters will be able to see the face of the infants in the videos The facial expressions and movements of these infants are required in rating the videos The observation of faces are not considered to be identifiers due to the young age of the subjects and their quickly changing appearance
ONE YEAR FOLLOW-UP Infants recruited will receive a one-year-old birthday card from the study team and their families will complete a 12-month Ages and Stages Questionnaire at their childs 12 month corrected age as a global developmental screening with a member of the study team
TWO-YEAR FOLLOW-UP NEURODEVELOPMENTAL ASSESSMENTS Participating families will return for a two-year follow-up visit and will receive the following batteries of standardized assessments
Table 1 Two-year neurodevelopmental assessment battery
Assessment name
Assessment requirements
Constructs assessed
Bayley Scales of Infant and Toddler Development version 4 Bayley-4
Trained assessor standardized test kit with manipulatives stimulus book manual
Cognitive language motor skills norm-referenced
Infant Toddler Quality of Life Questionnaire ITQOL
Parent questionnaire
Quality of Life
Child Behavior Checklist CBCL
Parent questionnaire
Socioemotional
Gross motor functional measure GMFM-66
Trained assessor manual standardized equipment
Motor ability in children diagnosed with cerebral palsy
Only infants diagnosed with CP will be tested with the GMFM-66
We will also record whether a child has received a diagnosis of CP If they have not received a diagnosis but have high-risk based on two-year presentation we will refer patients for diagnostic follow-up and then record outcome of that diagnosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None