Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337136
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-03-22
Brief Title:
neonAtal motoR paTtErn autoMatIc analySis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Neonatal Motor Pattern automatIc Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
AIMOTHERNeo
Brief Summary:
This project consists in developing a computerized clinical assessment system for newborns that takes into account the four major criteria of the various clinical scales facial mimicry cry posture and movement Classification of motor patterns according to gestational age at birth The aim of this work is the automated identification of pathological motor patterns related to anoxo-ischemic encephalopathybrachial plexus paralysisearly neonatal bacterial infectionstrokeetc
Detailed Description:
Neonatal Care and Newborn Examination
Every newborn undergoes a comprehensive clinical examination in the delivery room before being transferred to the postpartum ward with their mother decree of October 18 1994 At least one additional full examination is conducted during the maternity stay Mandatory before the 8th day of life this examination is recorded in the health booklet and allows for the issuance of the first health certificate 8th day certificate It is performed in the presence of the mother or both parents in a well-lit adequately heated room preferably before a meal or during a care routine when the child is alert and following hygiene rules handwashing use of a dedicated gown for the newborn and disinfection of equipment Significant clinical variations are possible among newborns and a number of minor anomalies may be detected
The neurological assessment of the newborn begins with gathering maximum information about prenatal history and birth context Family and social backgrounds are also crucial For instance previous neonatal deaths in the family may indicate autosomal recessive metabolic disorders while details of any previous maternal miscarriage are particularly relevant in suspected X-linked dominant disorders where male lethality is common Medical records are extremely useful sources for Apgar scores blood gas results antepartum monitoring data and any obstetric complications Clinical information regarding the immediate postpartum period known as the golden hour in high-risk groups can also be very valuable Additionally nurse observations when available are generally invaluable When evaluating newborns with paroxysmal disorders video sequences of the events in question can provide valuable diagnostic clues
Clinical examination remains a central element and perhaps the most cost-effective and safest tool for evaluating newborns suspected of having a neurological problem Wusthoff CJ How to use the neonatal neurological examination Arch Dis Child Educ Pract Ed 201398148-53 Extract from Mustafa A M Salih Clinical Child Neurology iBooks Thus the main objectives of the examination are to determine whether the newborn is neurologically normal or not and to initiate further investigations if necessary It also serves to assess the worsening or improvement of the newborns condition over time It should be noted that the newborns neurological status often cannot be fully determined by a single neurological examination especially if it is performed quite early In fact the predictive value of the neurological examination tends to improve with the newborns chronological age as illustrated by the case of a newborn who suffered significant hypoxic-ischemic injury at birth for example Indeed this childs clinical presentation will vary over time and a complete and accurate assessment of lesions is often possible remotely Furthermore it is well known that the newborns neurological status can be affected by a range of non-neurological factors such as medications administered to the mother during pregnancy infections respiratory disorders and unpleasant stimuli such as pain from the cold hand of an examiner for example and hunger
Description of the Research Focus There are several standardized and validated scales and approaches widely used in various neonatal units Each has its strengths and weaknesses but they are all comprehensive enough to provide an idea of the neurodevelopmental profile of both full-term and premature newborns Many of them such as the Dubowitz examination are freely accessible on the internet and in most neonatology manuals
Given the unique characteristics of the developing neonatal nervous system it is necessary to adapt the formal neurological examination applicable to older children and adults Observation is the first step of the examination and it is crucial to spend as much time as possible observing the baby and their interaction with the environment Dubowitz L Mercuri E Dubowitz V An optimality score for the neurologic examination of the term newborn J Pediatr 1998133406-16 Extract from Mustafa A M Salih Clinical Child Neurology iBooks This observation step is paramount in assessing the child and superior to the so-called manual examination which involves palpation and directed manipulation of the child This visual examination includes several registers related to the position and spontaneous movement of the child both in terms of limbs head movements eye movements and vocalizations Interactivity is also crucial as it indicates whether the child responds to voices and if automatic tracking mechanisms are in place
This newborn observation step is crucial It allows for the evaluation of cardinal functions such as motor skills reactivity and interaction and provides insight into the functioning of the patients central and peripheral neurological structures It is important to understand that these elements allow for a much more comprehensive evaluation of the newborn and that these same functions will be impaired during systemic pathophysiological phenomena for which neurological involvement is only secondary or indirect such as sepsis metabolic diseases anoxic-ischemic encephalopathies etc This is why this clinical examination even if very generic and not highly directed is of crucial importance in the newborns progression before discharge
Best practices often appear to be dependent on the caregiver Although the use of standardization in observation and data collection is unavoidable clinical examination remains a phenomenon an experience that includes a subjective element linked to the practitioners experience and competence Its expression thus exhibits a certain variability among patients In addition to interindividual variability and variability in the evaluators assessment there is the difficulty of evaluation related to the childs age
Therefore the observational component of the clinical examination in neonatology relies on the combination of three elements facial expression cry peripheral mobility andor postural tone Additionally despite various assessment scales pain remains challenging to evaluate and consequently to manage in the hospital setting in general and particularly in newborns
The AI MOTHER Neo solution is based on the technical foundation of
1 automated facial expression recognition
2 Cry Recognition
3 Movement and Posture Recognition
The justification for the duration of the research is based on several factors
1 Number of births per year The number of births recorded at Poissy-Saint-Germain Hospital is 4500 per year
2 Frequency of acquisitions Acquisitions will be made during visits on days 0 1 2 3 and 4 after birth providing a potential of 22500 acquisitions per year
3 Recruitment objective The goal is to obtain 10000 acquisitions during the research
4 Desired recruitmentacquisition rate A recruitmentacquisition rate of less than 15 is targeted
Based on these data a duration of 3 years is proposed to achieve the goal of 10000 acquisitions This allows for maintaining a reasonable and achievable recruitmentacquisition rate within the scope of the research
Primary Objective Our project aims to develop a computerized clinical assessment system for newborns that takes into account the three major criteria of various clinical scales facial expression cry posture and movement
Secondary Objectives The secondary objective is to characterize motor patterns that are specific to a given situation particularly a pathological situation The primary goal is to differentiate between a normal pattern and an abnormal pattern Once a sufficient number of acquisitions have been obtained we will attempt to identify specific patterns meaning to make diagnoses based on computerized analysis Patterns corresponding to early neonatal infection anoxic-ischemic encephalopathy brachial plexus paralysis among others will be identified and defined with the aim of maximizing the specificity and sensitivity of the tests
Primary Evaluation Criterion The chosen evaluation criterion is the comparison of the computer score with the clinical examination These scores will be described for each patient by the mean and standard deviation on normally distributed numerical parameters median 25th and 50th percentiles Comparisons between the two groups will be made using paired tests
Secondary Evaluation Criteria List the secondary evaluation criteria that address the secondary objectives
The acquisitions consist of 2D videos at 60Hz lasting 1 to 2 minutes taken during bathing or clinical examination of an awake undressed child either in a diaper or onesie These acquisitions can be made at multiple times during the maternity stay Days 01234 for the same child and for different children The collected data will include skeleton data where variables such as amplitude symmetry acceleration limb angles etc will be analyzed These various data will be combined to provide a specific movement profile and define specific patterns for a group of patients with a common characteristic
Number of Participating Centers This is a multicenter research involving two centers located in the Paris region
The maternity and neonatal medicine and intensive care units at Poissy-Saint-Germain Hospital
The Pediatric Intensive Care Unit at Raymond Poincaré Hospital Garches Possible extension to a surgical intensive care unit andor neonatology service
Subject Identification In this research subjects will be identified as follows Center number 3 numeric positions - Persons selection order number within the center 4 numeric positions - Initial of last name - Initial of first name This reference is unique and will be retained throughout the duration of the research
Eligibility Criteria After informing the parents or legal guardians about the objectives and procedures of the study oral information the protocol will be proposed to them
Inclusion Criteria The inclusion criteria are as follows
Children hospitalized in the maternity ward and in the Neonatal Medicine and Intensive Care Unit at Poissy-Saint-Germain Hospital
Agreement of legal guardians non-opposition Exclusion Criteria
Refusal of legal guardians
Minor parents
Conduct of the Research The project aims to develop an automated analysis system for sound and image using computer vision in newborns in maternity units The first phase of this project involves recording with consent sound and video sequences of newborns hospitalized in the maternity ward or in the Neonatal Medicine and Intensive Care Unit at Poissy-Saint-Germain Hospital These video sequences will be analyzed by facial recognition programs developed at the R2P2 Laboratory of the Pediatric Intensive Care Unit at Raymond Poincaré Hospital in Garches and by the company OSO Ai
Method
The acquisition is performed on a naked or diapered awake child lying on their back for 1 minute before bathing or clinical examination Clinical data of patients such as sex gestational age birth weight Apgar score cord blood gases pH and lactates and mode of delivery will be associated with each video
The first phase of the project involves retrieving videoaudio sequences of newborns at Days 01234 or beyond if hospitalization is prolonged These sequences will focus on the child and provide a complete view including the limbs The videos are stored on an encrypted hard drive under the responsibility of Professor Bergounioux who will regularly extract them These sequences will then be analyzed at the R2P2 Laboratory affiliated with the Pediatric Neurology Rehabilitation and Intensive Care Unit at Raymond Poincaré Hospital using modified open-source programs for facial and posture recognition as well as sound analysis A correlation will be established with clinical evaluations conducted in parallel with the video recordings
Population Follow-up Videoaudio sequence acquisition will be conducted for newborns at Days 01234 and beyond in case of continued hospitalization either in the maternity ward or in the Neonatal Medicine and Intensive Care Unit at Poissy-Saint-Germain Hospital
Duration of Patient Participation Patient participation is limited to the capture of images during their hospitalization
Non-interventional research involving human subjects poses no risk to patients Any adverse effects observed in patients participating in the research are reported by the investigators according to the local surveillance plans established within the framework of healthcare activities
The objective is to develop a system that allows for automated analysis of the newborn on both visual and auditory levels The primary goal is to define the normality of this clinical presentation which involves acquiring a total of 10000 video acquisitions 1 to 2 minutes each at Days 0123 and Day 4 for newborns hospitalized in the maternity ward or in the Neonatal Medicine and Intensive Care Unit
These films will be obtained with parental consent and solely intended for research and development of the automated system AI MOTHER Neo under the responsibility of Professor Bergounioux
The analysis aims to establish classification algorithms using neural networks that differentiate between a normal examination and an abnormal examination
Every newborn undergoes a comprehensive clinical examination in the delivery room before being transferred to the postpartum ward with their mother decree of October 18 1994 At least one additional full examination is conducted during the maternity stay Mandatory before the 8th day of life this examination is recorded in the health booklet and allows for the issuance of the first health certificate 8th day certificate It is performed in the presence of the mother or both parents in a well-lit adequately heated room preferably before a meal or during a care routine when the child is alert and following hygiene rules handwashing use of a dedicated gown for the newborn and disinfection of equipment Significant clinical variations are possible among newborns and a number of minor anomalies may be detected
The neurological assessment of the newborn begins with gathering maximum information about prenatal history and birth context Family and social backgrounds are also crucial For instance previous neonatal deaths in the family may indicate autosomal recessive metabolic disorders while details of any previous maternal miscarriage are particularly relevant in suspected X-linked dominant disorders where male lethality is common Medical records are extremely useful sources for Apgar scores blood gas results antepartum monitoring data and any obstetric complications Clinical information regarding the immediate postpartum period known as the golden hour in high-risk groups can also be very valuable Additionally nurse observations when available are generally invaluable When evaluating newborns with paroxysmal disorders video sequences of the events in question can provide valuable diagnostic clues
Clinical examination remains a central element and perhaps the most cost-effective and safest tool for evaluating newborns suspected of having a neurological problem Wusthoff CJ How to use the neonatal neurological examination Arch Dis Child Educ Pract Ed 201398148-53 Extract from Mustafa A M Salih Clinical Child Neurology iBooks Thus the main objectives of the examination are to determine whether the newborn is neurologically normal or not and to initiate further investigations if necessary It also serves to assess the worsening or improvement of the newborns condition over time It should be noted that the newborns neurological status often cannot be fully determined by a single neurological examination especially if it is performed quite early In fact the predictive value of the neurological examination tends to improve with the newborns chronological age as illustrated by the case of a newborn who suffered significant hypoxic-ischemic injury at birth for example Indeed this childs clinical presentation will vary over time and a complete and accurate assessment of lesions is often possible remotely Furthermore it is well known that the newborns neurological status can be affected by a range of non-neurological factors such as medications administered to the mother during pregnancy infections respiratory disorders and unpleasant stimuli such as pain from the cold hand of an examiner for example and hunger
Description of the Research Focus There are several standardized and validated scales and approaches widely used in various neonatal units Each has its strengths and weaknesses but they are all comprehensive enough to provide an idea of the neurodevelopmental profile of both full-term and premature newborns Many of them such as the Dubowitz examination are freely accessible on the internet and in most neonatology manuals
Given the unique characteristics of the developing neonatal nervous system it is necessary to adapt the formal neurological examination applicable to older children and adults Observation is the first step of the examination and it is crucial to spend as much time as possible observing the baby and their interaction with the environment Dubowitz L Mercuri E Dubowitz V An optimality score for the neurologic examination of the term newborn J Pediatr 1998133406-16 Extract from Mustafa A M Salih Clinical Child Neurology iBooks This observation step is paramount in assessing the child and superior to the so-called manual examination which involves palpation and directed manipulation of the child This visual examination includes several registers related to the position and spontaneous movement of the child both in terms of limbs head movements eye movements and vocalizations Interactivity is also crucial as it indicates whether the child responds to voices and if automatic tracking mechanisms are in place
This newborn observation step is crucial It allows for the evaluation of cardinal functions such as motor skills reactivity and interaction and provides insight into the functioning of the patients central and peripheral neurological structures It is important to understand that these elements allow for a much more comprehensive evaluation of the newborn and that these same functions will be impaired during systemic pathophysiological phenomena for which neurological involvement is only secondary or indirect such as sepsis metabolic diseases anoxic-ischemic encephalopathies etc This is why this clinical examination even if very generic and not highly directed is of crucial importance in the newborns progression before discharge
Best practices often appear to be dependent on the caregiver Although the use of standardization in observation and data collection is unavoidable clinical examination remains a phenomenon an experience that includes a subjective element linked to the practitioners experience and competence Its expression thus exhibits a certain variability among patients In addition to interindividual variability and variability in the evaluators assessment there is the difficulty of evaluation related to the childs age
Therefore the observational component of the clinical examination in neonatology relies on the combination of three elements facial expression cry peripheral mobility andor postural tone Additionally despite various assessment scales pain remains challenging to evaluate and consequently to manage in the hospital setting in general and particularly in newborns
The AI MOTHER Neo solution is based on the technical foundation of
1 automated facial expression recognition
2 Cry Recognition
3 Movement and Posture Recognition
The justification for the duration of the research is based on several factors
1 Number of births per year The number of births recorded at Poissy-Saint-Germain Hospital is 4500 per year
2 Frequency of acquisitions Acquisitions will be made during visits on days 0 1 2 3 and 4 after birth providing a potential of 22500 acquisitions per year
3 Recruitment objective The goal is to obtain 10000 acquisitions during the research
4 Desired recruitmentacquisition rate A recruitmentacquisition rate of less than 15 is targeted
Based on these data a duration of 3 years is proposed to achieve the goal of 10000 acquisitions This allows for maintaining a reasonable and achievable recruitmentacquisition rate within the scope of the research
Primary Objective Our project aims to develop a computerized clinical assessment system for newborns that takes into account the three major criteria of various clinical scales facial expression cry posture and movement
Secondary Objectives The secondary objective is to characterize motor patterns that are specific to a given situation particularly a pathological situation The primary goal is to differentiate between a normal pattern and an abnormal pattern Once a sufficient number of acquisitions have been obtained we will attempt to identify specific patterns meaning to make diagnoses based on computerized analysis Patterns corresponding to early neonatal infection anoxic-ischemic encephalopathy brachial plexus paralysis among others will be identified and defined with the aim of maximizing the specificity and sensitivity of the tests
Primary Evaluation Criterion The chosen evaluation criterion is the comparison of the computer score with the clinical examination These scores will be described for each patient by the mean and standard deviation on normally distributed numerical parameters median 25th and 50th percentiles Comparisons between the two groups will be made using paired tests
Secondary Evaluation Criteria List the secondary evaluation criteria that address the secondary objectives
The acquisitions consist of 2D videos at 60Hz lasting 1 to 2 minutes taken during bathing or clinical examination of an awake undressed child either in a diaper or onesie These acquisitions can be made at multiple times during the maternity stay Days 01234 for the same child and for different children The collected data will include skeleton data where variables such as amplitude symmetry acceleration limb angles etc will be analyzed These various data will be combined to provide a specific movement profile and define specific patterns for a group of patients with a common characteristic
Number of Participating Centers This is a multicenter research involving two centers located in the Paris region
The maternity and neonatal medicine and intensive care units at Poissy-Saint-Germain Hospital
The Pediatric Intensive Care Unit at Raymond Poincaré Hospital Garches Possible extension to a surgical intensive care unit andor neonatology service
Subject Identification In this research subjects will be identified as follows Center number 3 numeric positions - Persons selection order number within the center 4 numeric positions - Initial of last name - Initial of first name This reference is unique and will be retained throughout the duration of the research
Eligibility Criteria After informing the parents or legal guardians about the objectives and procedures of the study oral information the protocol will be proposed to them
Inclusion Criteria The inclusion criteria are as follows
Children hospitalized in the maternity ward and in the Neonatal Medicine and Intensive Care Unit at Poissy-Saint-Germain Hospital
Agreement of legal guardians non-opposition Exclusion Criteria
Refusal of legal guardians
Minor parents
Conduct of the Research The project aims to develop an automated analysis system for sound and image using computer vision in newborns in maternity units The first phase of this project involves recording with consent sound and video sequences of newborns hospitalized in the maternity ward or in the Neonatal Medicine and Intensive Care Unit at Poissy-Saint-Germain Hospital These video sequences will be analyzed by facial recognition programs developed at the R2P2 Laboratory of the Pediatric Intensive Care Unit at Raymond Poincaré Hospital in Garches and by the company OSO Ai
Method
The acquisition is performed on a naked or diapered awake child lying on their back for 1 minute before bathing or clinical examination Clinical data of patients such as sex gestational age birth weight Apgar score cord blood gases pH and lactates and mode of delivery will be associated with each video
The first phase of the project involves retrieving videoaudio sequences of newborns at Days 01234 or beyond if hospitalization is prolonged These sequences will focus on the child and provide a complete view including the limbs The videos are stored on an encrypted hard drive under the responsibility of Professor Bergounioux who will regularly extract them These sequences will then be analyzed at the R2P2 Laboratory affiliated with the Pediatric Neurology Rehabilitation and Intensive Care Unit at Raymond Poincaré Hospital using modified open-source programs for facial and posture recognition as well as sound analysis A correlation will be established with clinical evaluations conducted in parallel with the video recordings
Population Follow-up Videoaudio sequence acquisition will be conducted for newborns at Days 01234 and beyond in case of continued hospitalization either in the maternity ward or in the Neonatal Medicine and Intensive Care Unit at Poissy-Saint-Germain Hospital
Duration of Patient Participation Patient participation is limited to the capture of images during their hospitalization
Non-interventional research involving human subjects poses no risk to patients Any adverse effects observed in patients participating in the research are reported by the investigators according to the local surveillance plans established within the framework of healthcare activities
The objective is to develop a system that allows for automated analysis of the newborn on both visual and auditory levels The primary goal is to define the normality of this clinical presentation which involves acquiring a total of 10000 video acquisitions 1 to 2 minutes each at Days 0123 and Day 4 for newborns hospitalized in the maternity ward or in the Neonatal Medicine and Intensive Care Unit
These films will be obtained with parental consent and solely intended for research and development of the automated system AI MOTHER Neo under the responsibility of Professor Bergounioux
The analysis aims to establish classification algorithms using neural networks that differentiate between a normal examination and an abnormal examination
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01837-36 | REGISTRY | IDRCB | None |