Congenital Sensorineural Hearing LossEnTNDreNCT05423548
Analysis of Risk Factors of Neurodevelopmental Disorder in Deaf Infants Under Ten Months of Age.
An observational study of Congenital Sensorineural Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Among risk factors of neurodevelopmental disorder is congenital hearing loss. However, congenital deafness is neither necessary nor sufficient for the occurrence of warning signs of neurodevelopmental disorder. Read more about this study
- Who is it for?
- Ages Up to 10 months
- Conditions the study is for
- Congenital Sensorineural Hearing Loss
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2022to 9 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 10 months
- All sexes
- No healthy volunteers
- Child
Study population: Children with congenital deafness followed in the ENT department of the Necker hospital and having benefited before their 10 months, from a pilot consultation, filmed, jointly carried out by a child psychiatrist from the Therapeutic Childhood and Deafness Unit of St Maurice Hospitals Therapeutic Childhood and Deafness Unit of St Maurice Hospitals (UTES) and a psychologist from the ENT department of Necker for the neurodevelopmental risk assessment.
Who may be able to join
- Children with congenital deafness
- Follow-ups in the ENT department of the Necker hospital
- Having benefited from a pilot consultation, filmed, jointly carried out by a child psychiatrist from Therapeutic Childhood and Deafness Unit of St Maurice Hospitals (UTES) and a psychologist from the Necker ENT department for the assessment of neurodevelopmental risk
- Pilot consultation carried out before the child is 10 months old
- Information of the holders of parental authority and collection of their non-opposition to the study
Who cannot join
- Children assessed after 10 months
- Opposition of legal representatives for the use of their child's medical data and of the film
Trial locations and contacts
1 site in 1 country.
About this study
Among risk factors of neurodevelopmental disorder is congenital hearing loss. However, congenital deafness is neither necessary nor sufficient for the occurrence of warning signs of neurodevelopmental disorder. The investigative team hypothesizes that the co-occurrence of these two clinical entities results from a common origin, within a syndromic diagnosis including other medical issues. These situations would therefore be very different from those of babies suffering from isolated sensorineural deafness.
This study aims to identify which factors are statistically correlated with the association of congenital deafness and early symptoms of neurodevelopmental disorder, thanks to a partnership between a regional center for psychiatry of deaf children (Therapeutic Childhood and Deafness Unit of St Maurice Hospitals, UTES) and a pediatric audiophonology department (ENT department of the Necker-Enfants Malades hospital).
Read more
This work is based on a cohort of 26 children under ten months of age diagnosed with severe to profound congenital sensorineural hearing loss. As part of their pre-implantation cochlear assessment, a consultation was filmed to precisely analyze the interactional and sensorimotor skills of these children (clinical observations, administration of a specific evaluation grid called Olliac Grid), after reviewing the films. The investigative team will then be able to grade the neurodevelopmental risk.
In order to clarify what factors are linked with a neurodevelopmental risk, medical data concerning the child's family context, birth, and audiological profile will also be collected, and put in perspective with the assessed neurodevelopmental risk gradation.
Read the detailed description
Congenital deafness remains among well-known risk factors for Neurodevelopmental Disorders, in particular Autism Spectrum Disorders (ASD). According to current data of the literature, the risk of ASD in children with hearing loss is twice as high as in the general population. Furthermore, while the main aim of French government strategy for autism 2018-2022 is to promote early detection and intervention, it is noted that deaf children suffer from a significant diagnostic delay with regard to autism spectrum disorders.
Today it is possible to detect clinical warning signs of a neurodevelopmental impairment since the first months of life. The investigative team believe that these warning signs present a risk for further severe disability such as ASD, Attention Deficit / Hyperactivity Disorder (ADHD), learning disorders and so on, that is to say every psychiatric diagnosis included in neurodevelopmental disorders as the DSM-V classifies them. This encourages clinicians to assess every new-born with high risk factors of neurodevelopmental disorder.
No research has been conducted on the screening of Autism Spectrum Disorders (and more broadly of Neurodevelopmental Disorders) in deaf infants and the correlations with their clinical profile (health conditions, psychomotor development and typology of deafness).
One of the difficulties lies in the fact that these children constitute a heterogeneous population. Studying deaf infants requires taking into account multiple parameters, such as etiology of the hearing loss, associated disorders, or early life history. Moreover, first months of a born-deaf child are a highly emotional and demanding period for parents. However, the investigative team hope that observing this population will help better understand what constitutes in newborns with congenital hearing loss, associated risk factors for autism.
Knowing that congenital deafness is neither necessary nor sufficient for the early occurrence of a neurodevelopmental warning signs, the investigative team hypothesizes that the co-occurrence of these two medical conditions results from a common origin, as a syndromic diagnosis including other medical issues. These situations would therefore be very different from those of babies suffering from isolated sensorineural deafness.
The investigative team aim to identify which factors are statistically correlated with the association of congenital deafness and early diagnosis of clinical signs of neurodevelopmental risk, thanks to a partnership between a regional center for psychiatry of deaf children (Therapeutic Childhood and Deafness Unit of St Maurice Hospitals, UTES) and an infant audiophonology department (ENT department of the Necker-Enfants Malades hospital).
This work is based on a cohort of 26 infants under ten months of age diagnosed with severe to profound congenital sensorineural hearing loss. The enrollment of the patients took place from May 2018 to April 2020, based on consultations for the management of deafness in the audiophonology department of the Necker Enfants Malades Hospital in Paris.
As part of the pre-implantation cochlear assessment carried out in the audiophonology department of the Necker Enfants Malades Hospital, each child in the cohort has attended a consultation to assess the risk of neurodevelopmental disorder. This pilot consultation was carried out by a child psychiatrist from the UTES together with a psychologist from the ENT department of Necker, and was filmed to precisely analyze the interactional skills of the children (clinical observations, administration of a specific evaluation grid called Olliac Grid (Olliac et al, 2017), gradation of the neurodevelopmental risk), after reviewing the films.
Anamnesis data concerning the family context (parental and sibling history) and birth (antenatal conditions, term, per and post-natal complications) will be collected, with particular attention to the elements already identified in the literature as associated with risk of Neurodevelopmental Disorders. In order to clarify what factors are linked with a neurodevelopmental risk, medical data concerning the child's family context, birth, and audiological profile will be collected, and put in perspective with the previously assessed neurodevelopmental risk gradation.
- Conditions
- Congenital Sensorineural Hearing Loss
- Keywords
- Congenital sensorineural hearing loss, Neurodevelopmental Disorders
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with congenital deafness | Children with congenital deafness followed in the ENT department of the Necker hospital and having benefited before their 10 months, from a pilot consultation, filmed, jointly carried out by a child psychiatrist from the Therapeutic Childhood and Deafness Unit of St Maurice Hospitals (UTES) and a psychologist from the ENT department of Necker for the neurodevelopmental risk assessment, between May 2018 to April 2020. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's interactional behaviours
From the study of the psychiatric assessment filmed, children will be seprated in 2 categories wether they present interactional warning signs of neurodevelopmental disorders (NDD) or not.
The children's interactional behaviours quality will be assessed using the Olliac grid : a standardized clinical assessment of an infant's ability to initiate an interaction and/or respond to one (Olliac et al, 2017). According to answers to 4 questions about an infant's behaviors during a health appointment, a score will be attributed. The maximum score is 15 and means good ability to interact with parents and unknown people. A score ≤ 3 or ≤ 5, depending on the infant's age is considered "at risk" for autism spectrum disorder (ASD).
Children will be considered presenting Interactional Warning Signs of NDD if they have an " at risk " score at the Olliac grid, which means a total score ≤ 3 for children aged between 4 months and 8 months + 30 days, and a score ≤ 5 for children aged over 9 months.
Measured: 12 months
Warning signs of neurodevelopmental disorders
From the study and the description of the psychiatric assessment carried out and filmed, children will be seprated in two descriptive categories wether they present warning signs of neurodevelopmental disorders or not.
The sensorimotor development of children will be described from the video recording and compared to the development of a typical hearing child.
Children will be considered presenting sensorimotor warning signs of NDD if they exhibit two or more of the following conditions:
- Global hypertonia or hypotonia
- Jolt in response to visual, tactile, or vestibular moderate stimuli
- Repetitive dorsal hyperextensions
- Motor restlessness
- Lack of motor fluidity
- Excessive use of thoraco-pneumatic tonus
- Motor development delay These conditions are known to reflect psychomotor development vulnerability, and are easy to assess by experienced early childhood professionals.
Measured: 12 months
Secondary outcomes (5)
Perinatal complication
Description of clinical profiles of the children from medical file. Comparison of frequencies of perinatal complication between infants presenting warning signs of NDD and infants who don't. The clinical data will be compared in terms of percentages, following a binary measure (present/absent).
Any perinatal complication will count for "present". Here is some examples of what could be considered : premature delivery threat, fetal growth restriction, gestational diabetes, emergency ceasarean section, low birth weight, neonatal resuscitation, hyperbilirubinemia.
Measured: 12 months
Preterm birth
Description of clinical profiles of the children from medical file. Preterm birth is a major cause of NDD. This clinical data will be compared in terms of percentages, following a binary measure (present/absent) between infants presenting warning signs of NDD and infants who don't.
Comparison of frequencies of preterm birth. Any birth under 37 weeks of gestation will be counted as "present".
Measured: 12 months
Neonatal positive Cytomegalovirus (CMV) status
Description of clinical profiles of the children from medical file. Neonatal positive Cytomegalovirus (CMV) status is a major cause of congenital hearing loss, and a risk factor of NDD. This clinical data will be compared in terms of percentages, following a binary measure (present/absent) between infants presenting warning signs of NDD and infants who don't. A positive CMV status will be considered as "present".
Measured: 12 months
Sensorimotor disturbances in the first months
Description of clinical profiles of the children from medical file. The clinical data will be compared in terms of percentages, following a binary measure (present/absent) between infants presenting warning signs of NDD and infants who don't.
Comparison of frequencies of causes of sensorimotor disturbances in the first months: any of the following conditions will be counted as "present": gastrostomy, feeding disorder, and/or Gastroesophageal reflux.
Measured: 12 months
Vestibular hyporeflexia or areflexia
Description of clinical profiles of the children from medical file. The clinical data will be compared in terms of percentages, following a binary measure (present/absent) between infants presenting warning signs of NDD and infants who don't.
Comparison of frequencies of vestibular dysfunction. Either vestibular hyporeflexia or areflexia will be considered as "present". These data are available in every audiophonologic medical file, as every deaf infant gets a vestibular assessment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start3 Aug 2022
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Natalie Loundon, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisSalomé Akrich, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423548
- Sponsor's protocol ID
- APHP220048
- Acronym
- EnTNDre
- Status last verified
- Sep 2025
- First submitted
- 17 Feb 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akrich S, Parlato de Oliveira E, Favrot-Meunier C, Rebichon C, de Clerck A, Ettori S, Rouillon I, Prang I, Loundon N. Analysis of specific risk factors of neurodevelopmental disorder in hearing-impaired infants under ten months of age: "EnTNDre" an opening research stemming from a transdisciplinary partnership. Int J Pediatr Otorhinolaryngol. 2023 Mar;166:111453. doi: 10.1016/j.ijporl.2023.111453. Epub 2023 Jan 21.
PubMed 36746056
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors of Neurodevelopmental Disorder in Deaf Infants Under Ten Months of Age.
- ClinicalTrials.gov ID
- NCT05423548
- Acronym / sponsor ID
- EnTNDre / APHP220048
- Conditions
- Congenital Sensorineural Hearing Loss
- Keywords
- Congenital sensorineural hearing loss, Neurodevelopmental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among risk factors of neurodevelopmental disorder is congenital hearing loss. However, congenital deafness is neither necessary nor sufficient for the occurrence of warning signs of neurodevelopmental disorder. The investigative team hypothesizes that the co-occurrence of these two clinical entities results from a common origin, within a syndromic diagnosis including other medical issues. These situations would therefore be very different from those of babies suffering from isolated sensorineural deafness.
This study aims to identify which factors are statistically correlated with the association of congenital deafness and early symptoms of neurodevelopmental disorder, thanks to a partnership between a regional center for psychiatry of deaf children (Therapeutic Childhood and Deafness Unit of St Maurice Hospitals, UTES) and a pediatric audiophonology department (ENT department of the Necker-Enfants Malades hospital).
This work is based on a cohort of 26 children under ten months of age diagnosed with severe to profound congenital sensorineural hearing loss. As part of their pre-implantation cochlear assessment, a consultation was filmed to precisely analyze the interactional and sensorimotor skills of these children (clinical observations, administration of a specific evaluation grid called Olliac Grid), after reviewing the films. The investigative team will then be able to grade the neurodevelopmental risk.
In order to clarify what factors are linked with a neurodevelopmental risk, medical data concerning the child's family context, birth, and audiological profile will also be collected, and put in perspective with the assessed neurodevelopmental risk gradation.
Detailed description
Congenital deafness remains among well-known risk factors for Neurodevelopmental Disorders, in particular Autism Spectrum Disorders (ASD). According to current data of the literature, the risk of ASD in children with hearing loss is twice as high as in the general population. Furthermore, while the main aim of French government strategy for autism 2018-2022 is to promote early detection and intervention, it is noted that deaf children suffer from a significant diagnostic delay with regard to autism spectrum disorders.
Today it is possible to detect clinical warning signs of a neurodevelopmental impairment since the first months of life. The investigative team believe that these warning signs present a risk for further severe disability such as ASD, Attention Deficit / Hyperactivity Disorder (ADHD), learning disorders and so on, that is to say every psychiatric diagnosis included in neurodevelopmental disorders as the DSM-V classifies them. This encourages clinicians to assess every new-born with high risk factors of neurodevelopmental disorder.
No research has been conducted on the screening of Autism Spectrum Disorders (and more broadly of Neurodevelopmental Disorders) in deaf infants and the correlations with their clinical profile (health conditions, psychomotor development and typology of deafness).
One of the difficulties lies in the fact that these children constitute a heterogeneous population. Studying deaf infants requires taking into account multiple parameters, such as etiology of the hearing loss, associated disorders, or early life history. Moreover, first months of a born-deaf child are a highly emotional and demanding period for parents. However, the investigative team hope that observing this population will help better understand what constitutes in newborns with congenital hearing loss, associated risk factors for autism.
Knowing that congenital deafness is neither necessary nor sufficient for the early occurrence of a neurodevelopmental warning signs, the investigative team hypothesizes that the co-occurrence of these two medical conditions results from a common origin, as a syndromic diagnosis including other medical issues. These situations would therefore be very different from those of babies suffering from isolated sensorineural deafness.
The investigative team aim to identify which factors are statistically correlated with the association of congenital deafness and early diagnosis of clinical signs of neurodevelopmental risk, thanks to a partnership between a regional center for psychiatry of deaf children (Therapeutic Childhood and Deafness Unit of St Maurice Hospitals, UTES) and an infant audiophonology department (ENT department of the Necker-Enfants Malades hospital).
This work is based on a cohort of 26 infants under ten months of age diagnosed with severe to profound congenital sensorineural hearing loss. The enrollment of the patients took place from May 2018 to April 2020, based on consultations for the management of deafness in the audiophonology department of the Necker Enfants Malades Hospital in Paris.
As part of the pre-implantation cochlear assessment carried out in the audiophonology department of the Necker Enfants Malades Hospital, each child in the cohort has attended a consultation to assess the risk of neurodevelopmental disorder. This pilot consultation was carried out by a child psychiatrist from the UTES together with a psychologist from the ENT department of Necker, and was filmed to precisely analyze the interactional skills of the children (clinical observations, administration of a specific evaluation grid called Olliac Grid (Olliac et al, 2017), gradation of the neurodevelopmental risk), after reviewing the films.
Anamnesis data concerning the family context (parental and sibling history) and birth (antenatal conditions, term, per and post-natal complications) will be collected, with particular attention to the elements already identified in the literature as associated with risk of Neurodevelopmental Disorders. In order to clarify what factors are linked with a neurodevelopmental risk, medical data concerning the child's family context, birth, and audiological profile will be collected, and put in perspective with the previously assessed neurodevelopmental risk gradation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with congenital deafness | – | –Children with congenital deafness followed in the ENT department of the Necker hospital and having benefited before their 10 months, from a pilot consultation, filmed, jointly carried out by a child psychiatrist from the Therapeutic Childhood and Deafness Unit of St Maurice Hospitals (UTES) and a psychologist from the ENT department of Necker for the neurodevelopmental risk assessment, between May 2018 to April 2020. |
Who may qualify
- Ages
- Up to 10 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with congenital deafness followed in the ENT department of the Necker hospital and having benefited before their 10 months, from a pilot consultation, filmed, jointly carried out by a child psychiatrist from the Therapeutic Childhood and Deafness Unit of St Maurice Hospitals Therapeutic Childhood and Deafness Unit of St Maurice Hospitals (UTES) and a psychologist from the ENT department of Necker for the neurodevelopmental risk assessment.
Key inclusion criteria (5 listed)
- Children with congenital deafness
- Follow-ups in the ENT department of the Necker hospital
- Having benefited from a pilot consultation, filmed, jointly carried out by a child psychiatrist from Therapeutic Childhood and Deafness Unit of St Maurice Hospitals (UTES) and a psychologist from the Necker ENT department for the assessment of neurodevelopmental risk
- Pilot consultation carried out before the child is 10 months old
- Information of the holders of parental authority and collection of their non-opposition to the study
Key exclusion criteria (2 listed)
- Children assessed after 10 months
- Opposition of legal representatives for the use of their child's medical data and of the film
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Children's interactional behaviours
Time frame: 12 months
From the study of the psychiatric assessment filmed, children will be seprated in 2 categories wether they present interactional warning signs of neurodevelopmental disorders (NDD) or not. The children's interactional behaviours quality will be assessed using the Olliac grid : a standardized clinical assessment of an infant's ability to initiate an interaction and/or respond to one (Olliac et al, 2017). According to answers to 4 questions about an infant's behaviors during a health appointment, a score will be attributed. The maximum score is 15 and means good ability to interact with parents and unknown people. A score ≤ 3 or ≤ 5, depending on the infant's age is considered "at risk" for autism spectrum disorder (ASD). Children will be considered presenting Interactional Warning Signs of NDD if they have an " at risk " score at the Olliac grid, which means a total score ≤ 3 for children aged between 4 months and 8 months + 30 days, and a score ≤ 5 for children aged over 9 months.
Warning signs of neurodevelopmental disorders
Time frame: 12 months
From the study and the description of the psychiatric assessment carried out and filmed, children will be seprated in two descriptive categories wether they present warning signs of neurodevelopmental disorders or not. The sensorimotor development of children will be described from the video recording and compared to the development of a typical hearing child. Children will be considered presenting sensorimotor warning signs of NDD if they exhibit two or more of the following conditions: * Global hypertonia or hypotonia * Jolt in response to visual, tactile, or vestibular moderate stimuli * Repetitive dorsal hyperextensions * Motor restlessness * Lack of motor fluidity * Excessive use of thoraco-pneumatic tonus * Motor development delay These conditions are known to reflect psychomotor development vulnerability, and are easy to assess by experienced early childhood professionals.
5 secondary outcomes
Perinatal complication
Time frame: 12 months
Preterm birth
Time frame: 12 months
Neonatal positive Cytomegalovirus (CMV) status
Time frame: 12 months
Sensorimotor disturbances in the first months
Time frame: 12 months
Vestibular hyporeflexia or areflexia
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 36746056Akrich S, Parlato de Oliveira E, Favrot-Meunier C, Rebichon C, de Clerck A, Ettori S, Rouillon I, Prang I, Loundon N. Analysis of specific risk factors of neurodevelopmental disorder in hearing-impaired infants under ten months of age: "EnTNDre" an opening research stemming from a transdisciplinary partnership. Int J Pediatr Otorhinolaryngol. 2023 Mar;166:111453. doi: 10.1016/j.ijporl.2023.111453. Epub 2023 Jan 21.
- Individual participant dataSharing planned: No
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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.
Natalie Loundon, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Salomé Akrich principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Sensorineural Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 2 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Children's interactional behaviours (time frame: 12 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 NCT05423548, 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 12 Sep 2025.