InfantApp-eMot-QualiNCT04523441
Early Support and Physiotherapy for Children and Their Motor Skills
An observational study of Infant and Cerebral Palsy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The App-eMot-Quali project proposed here is the first phase in the implementation of a care pathway supported by a digital tool. It consists of a qualitative study allowing individual interviews to be conducted with parents of infants at high risk of cerebral palsy and health professionals in order to identify and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infant, Cerebral Palsy, Neonatal
- What is being tested?
- Focus group and Semi-directive interview
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2020to 5 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents of children under 24 months of age and health professionals working in the paediatric intensive care unit at the Dijon Bougogne University Hospital.
Who may be able to join
- For the parents:
- Parents of children under 24 months of age at high risk of cerebral palsy who have given their oral consent.
- Children at high risk of cerebral palsy are defined as :
- Premature children ≤ 31 WG + 6 days or birth weight less than 1000g.
- Children who have had a stroke or stage 2 or 3 hypoxia-ischemia according to the Sarnat classification.
- The selection of parents may be retrospective with less than 24 months since hospital discharge.
- For the health professionals:
- Physiotherapists, psychomotricians, psychologists and doctors involved in the care of children at high risk of cerebral palsy.
Who cannot join
- A person who is physically or cognitively unable to participate in a one-on-one interview or who does not have a sufficient command of the French language.
- Parents aged <18 years
- Parents in protective custody
- Parents of children with major orthopedic or traumatic disorders unrelated to the high risk of cerebral palsy.
- Parents of a child with a genetic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Needs and Difficulties Associated With the Perceptual-motor Management of Infants at High Risk of Cerebral Palsy During the First 24 Months Following Neonatal Hospitalization. Qualitative Study Among Parents and Health Professionals
The App-eMot-Quali project proposed here is the first phase in the implementation of a care pathway supported by a digital tool. It consists of a qualitative study allowing individual interviews to be conducted with parents of infants at high risk of cerebral palsy and health professionals in order to identify and precisely describe the needs and difficulties present during the child's rehabilitative care during the first months of life.
- Conditions
- Infant, Cerebral Palsy, Neonatal
- Being tested
- Focus group, Semi-directive interview
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupOther
Holding of a focus group by a sociologist
Semi-directive interviewOther
Conducting a semi-directive interview by a sociologist after discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| Parents | man or woman Receives: Other: Semi-directive interview | |
| Professionals | health professionals in charge of monitoring children Receives: Other: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Typology and categorization of the needs and difficulties encountered by the parents.
collected through semi-directive individual interviews with parents
Measured: Through study completion an average of 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start5 Oct 2020
- Primary completion5 Jan 2021
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523441
- Sponsor's protocol ID
- KRUMM APPARA 2019
- Acronym
- App-eMot-Quali
- Status last verified
- Sep 2021
- First submitted
- 19 Aug 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Needs and Difficulties Associated With the Perceptual-motor Management of Infants at High Risk of Cerebral Palsy During the First 24 Months Following Neonatal Hospitalization. Qualitative Study Among Parents and Health Professionals
- ClinicalTrials.gov ID
- NCT04523441
- Acronym / sponsor ID
- App-eMot-Quali / KRUMM APPARA 2019
- Conditions
- Infant, Cerebral Palsy, Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 21 Aug 2020 (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 App-eMot-Quali project proposed here is the first phase in the implementation of a care pathway supported by a digital tool. It consists of a qualitative study allowing individual interviews to be conducted with parents of infants at high risk of cerebral palsy and health professionals in order to identify and precisely describe the needs and difficulties present during the child's rehabilitative care during the first months of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents | – | Other: Semi-directive interviewman or woman |
| Professionals | – | Other: Focus grouphealth professionals in charge of monitoring children |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of children under 24 months of age and health professionals working in the paediatric intensive care unit at the Dijon Bougogne University Hospital.
Key inclusion criteria (8 listed)
- For the parents:
- Parents of children under 24 months of age at high risk of cerebral palsy who have given their oral consent.
- The selection of parents may be retrospective with less than 24 months since hospital discharge.
- For the health professionals:
- Physiotherapists, psychomotricians, psychologists and doctors involved in the care of children at high risk of cerebral palsy.
Key exclusion criteria (5 listed)
- A person who is physically or cognitively unable to participate in a one-on-one interview or who does not have a sufficient command of the French language.
- Parents aged <18 years
- Parents in protective custody
- Parents of children with major orthopedic or traumatic disorders unrelated to the high risk of cerebral palsy.
- Parents of a child with a genetic disease.
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 |
|---|---|---|
| Focus groupHolding of a focus group by a sociologist | Other | Professionals |
| Semi-directive interviewConducting a semi-directive interview by a sociologist after discharge from hospital | Other | Parents |
Primary outcome
Typology and categorization of the needs and difficulties encountered by the parents.
Time frame: Through study completion an average of 21 months
collected through semi-directive individual interviews with parents
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 1 Oct 2021.
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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?
An observational study of Infant and Cerebral Palsy, run by Centre Hospitalier Universitaire Dijon 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 8 inclusion and 5 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 1 Oct 2021. 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?
Typology and categorization of the needs and difficulties encountered by the parents. (time frame: Through study completion an average of 21 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 1 Oct 2021.