Premature BirthNEORTHONCT05992181
Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns
A study testing NEORTHO in people with Premature Birth, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 hours to 3 months
- Conditions the study is for
- Premature Birth
- What is being tested?
- NEORTHO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2023to 20 Jun 2024
- Phase
- Interventional
- 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 24 hours to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Premature Birth
- Being tested
- NEORTHO
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEORTHOOther
early orofacial stimulation
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | With the speech therapy already in place in the department. |
| experimental group | Experimental | With the speech therapy already in place in the department, plus access to videos and the introduction of early orofacial stimulation. Receives: Other: NEORTHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Milk taken daily
Percentage of the amount of milk taken daily (measure taken once per week throughout the study).
Measured: up to 3 months
Secondary outcomes (6)
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)
Measured: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
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)
Measured: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Milk flower (PIBBS questionnaire)
global observation and functional assessment (0=absent to 20=normal)
Measured: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Newborn Pain and Discomfort Scale (EDIN questionnaire)
Newborn Pain and Discomfort Scale (0=normal to 15=painful)
Measured: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
anxiety questionnaire
anxiety questionnaire for the parents (0=relaxed to 2=anxious)
Measured: Day 0, Day 30, Day 60, Day 90
satisfaction questionnaire
satisfaction questionnaire for the application (0=unsatisfied to 3=satisfied)
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start15 Sep 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992181
- Sponsor's protocol ID
- 2023-A01290-45
- Acronym
- NEORTHO
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns
- ClinicalTrials.gov ID
- NCT05992181
- Acronym / sponsor ID
- NEORTHO / 2023-A01290-45
- Conditions
- Premature Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 15 Aug 2023 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –With the speech therapy already in place in the department. |
| experimental group | Experimental | Other: NEORTHOWith the speech therapy already in place in the department, plus access to videos and the introduction of early orofacial stimulation. |
Who may qualify
- Ages
- 24 hours to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEORTHOearly orofacial stimulation | Other | experimental group |
Primary outcome
Milk taken daily
Time frame: up to 3 months
Percentage of the amount of milk taken daily (measure taken once per week throughout the study).
6 secondary outcomes
Behavior scale for the analysis of oral reflexes and suction reflexes (MIAM questionnaire)
Time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Feeding behavior scale for premature infants moving to bottle-feeding (ECEPAB questionnaire
Time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Milk flower (PIBBS questionnaire)
Time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Newborn Pain and Discomfort Scale (EDIN questionnaire)
Time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
anxiety questionnaire
Time frame: Day 0, Day 30, Day 60, Day 90
satisfaction questionnaire
Time frame: Day 90
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 15 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEORTHO in people with Premature Birth, run by Centre Hospitalier Sud Francilien 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 3 inclusion and 4 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 15 Aug 2024. 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?
Milk taken daily (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024.