NCT05423548|Completed
Analysis of Risk Factors of Neurodevelopmental Disorder in Deaf Infants Under Ten Months of Age.
EnTNDre
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EnTNDre
Sponsor study identifier
observational
22
1 country
1
Study Start
August 3, 2022
Actual (reported)Primary Completion
September 9, 2022
Actual (reported)Study Completion
September 9, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 9, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 17, 2022
Actual (reported)June 21, 2022
Actual (reported)August 3, 2022
Actual (reported)September 9, 2022
Actual (reported)September 9, 2022
Actual (reported)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.
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.
12 months
Perinatal complication
12 months
Preterm birth
12 months
Neonatal positive Cytomegalovirus (CMV) status
12 months
Sensorimotor disturbances in the first months
12 months
Vestibular hyporeflexia or areflexia
12 months
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.
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.
Hôpital Necker-Enfants Malades
Paris, 75015, France
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.
Natalie Loundon, MD, PhD
Assistance Publique - Hôpitaux de Paris
Salomé Akrich
Assistance Publique - Hôpitaux de Paris
22 participants (actual enrollment reported by the registry).
First Submitted
February 17, 2022
First Posted
June 21, 2022
Study Start
August 3, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
September 9, 2022
Actual (reported)Study Completion
September 9, 2022
Actual (reported)Last Updated
September 12, 2025
Record last verified: 2025-09
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