Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns (NEORTHO)
Primary Purpose
Premature Birth
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NEORTHO
Sponsored by
About this trial
This is an interventional prevention trial for Premature Birth
Eligibility Criteria
Inclusion Criteria: Child born prematurely before 29 weeks of amenorrhea (SA). Alive for minimum 24h. Holders of parental authority who have been informed of the study and have not objected. Exclusion Criteria: Child born after 29 weeks of amenorrhea. with a genetic or severe neurological pathology or withdrawal syndrome. with a vital prognosis. whose family home is too far from the service.
Sites / Locations
- Centre Hospitalier Sud FrancilienRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
experimental group
Arm Description
With the speech therapy already in place in the department.
With the speech therapy already in place in the department, plus access to videos and the introduction of early orofacial stimulation.
Outcomes
Primary Outcome Measures
Milk taken daily
Percentage of the amount of milk taken daily (measure taken once per week throughout the study).
Secondary Outcome Measures
Behavior scale for the analysis of oral reflexes and suction reflexes (MIAM questionnaire)
Analysis of oral and suction reflexes : global observation and functional assessment. (0=absent to 2=normal)
Feeding behavior scale for premature infants moving to bottle-feeding (ECEPAB questionnaire
feeding behavior scale for premature infants moving to bottle-feeding (0=absent to 18=normal)
Milk flower (PIBBS questionnaire)
global observation and functional assessment (0=absent to 20=normal)
Newborn Pain and Discomfort Scale (EDIN questionnaire)
Newborn Pain and Discomfort Scale (0=normal to 15=painful)
anxiety questionnaire
anxiety questionnaire for the parents (0=relaxed to 2=anxious)
satisfaction questionnaire
satisfaction questionnaire for the application (0=unsatisfied to 3=satisfied)
Full Information
NCT ID
NCT05992181
First Posted
July 28, 2023
Last Updated
October 13, 2023
Sponsor
Centre Hospitalier Sud Francilien
1. Study Identification
Unique Protocol Identification Number
NCT05992181
Brief Title
Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns
Acronym
NEORTHO
Official Title
Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Sud Francilien
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study concerns the creation and implementation of a digital tool presenting the various orofacial stimuli that can be offered to premature newborns. This app is intended for parents, to allow them to play a more active role in their child's care, and provide them with special time with their child. The notion of pleasure is very important to us, and it's vital to help parents rediscover this feeling with their child. Different profiles will be created to individualize our recommendations, facilitate the understanding of orofacial stimuli, make them more concrete than drawings, and provide care adapted to each patient and improve the development of newborns through more regular orofacial stimulation.
Detailed Description
Two groups will be formed:
Group A - control: receiving the speech therapy currently in place in the department.
Group B - experimental: will receive the same care as the first group, plus access to the videos and the introduction of early orofacial stimulation.
Group B: First, an initial assessment will be performed in speech-language pathology of the oro-myofunctional and oral functions of the newborn. This will determine which orofacial solicitations to give to the baby and create in the patient's profile.
Parents will be trained in orofacial stimulation and will be coached during the first sessions. When parents are ready, access will be given to their personal space on the application. Appointments will be scheduled to remodel the treatment if necessary. Sucking (ECEPAB), feeding (PIBBS) and behavioural (EDIN) abilities will be assessed. Parents will be asked to fill out a questionnaire about their feelings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
With the speech therapy already in place in the department.
Arm Title
experimental group
Arm Type
Experimental
Arm Description
With the speech therapy already in place in the department, plus access to videos and the introduction of early orofacial stimulation.
Intervention Type
Other
Intervention Name(s)
NEORTHO
Intervention Description
early orofacial stimulation
Primary Outcome Measure Information:
Title
Milk taken daily
Description
Percentage of the amount of milk taken daily (measure taken once per week throughout the study).
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Behavior scale for the analysis of oral reflexes and suction reflexes (MIAM questionnaire)
Description
Analysis of oral and suction reflexes : global observation and functional assessment. (0=absent to 2=normal)
Time Frame
Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Title
Feeding behavior scale for premature infants moving to bottle-feeding (ECEPAB questionnaire
Description
feeding behavior scale for premature infants moving to bottle-feeding (0=absent to 18=normal)
Time Frame
Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Title
Milk flower (PIBBS questionnaire)
Description
global observation and functional assessment (0=absent to 20=normal)
Time Frame
Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Title
Newborn Pain and Discomfort Scale (EDIN questionnaire)
Description
Newborn Pain and Discomfort Scale (0=normal to 15=painful)
Time Frame
Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Title
anxiety questionnaire
Description
anxiety questionnaire for the parents (0=relaxed to 2=anxious)
Time Frame
Day 0, Day 30, Day 60, Day 90
Title
satisfaction questionnaire
Description
satisfaction questionnaire for the application (0=unsatisfied to 3=satisfied)
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child born prematurely before 29 weeks of amenorrhea (SA).
Alive for minimum 24h.
Holders of parental authority who have been informed of the study and have not objected.
Exclusion Criteria:
Child born after 29 weeks of amenorrhea.
with a genetic or severe neurological pathology or withdrawal syndrome.
with a vital prognosis.
whose family home is too far from the service.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline BALANCON
Phone
01 61 69 37 31
Email
caroline.balancon@chsf.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline TOURTE
Phone
01 61 69 31 50
Email
caroline.tourte@chsf.fr
Facility Information:
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline BALANCON
Phone
01 61 69 37 31
Email
caroline.balancon@chsf.fr
First Name & Middle Initial & Last Name & Degree
Véronique ZUPAN-SIMUNEK, MD
Email
veronique.zupan@aphp.fr
First Name & Middle Initial & Last Name & Degree
Caroline BALANCON
First Name & Middle Initial & Last Name & Degree
Solène BONNET
First Name & Middle Initial & Last Name & Degree
Sixtine CASAGRANDE
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns
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