Cerebral PalsyDeStreSsNCT05233371
Study of Parental Stress and Care Consumption Until 24 Months Corrected Age of Infants at a High Risk of Developmental Delay, After Discharge From Neonatal Intensive Care
An observational study of Cerebral Palsy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Cerebral palsy (CP) is the leading cause of motor disability in children, affecting 125,000 people in France and with 1800 new cases per year. Prematurity remains a major risk factor, although children born at term represent 52% of children with cerebral palsy in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Parenting Stress Index (PSI), Collection of health care consumption and Assessment of parent satisfaction
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2022to 13 Mar 2025
- 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 at high risk of developmental delay
Who may be able to join
- Parents of children hospitalized in the neonatal unit of the CHU Dijon and meeting at least one of the criteria below:
- Premature infants ≤ 31 weeks amenorrhea + 6 days
- And/or birthweight less than 1500 g,
- And/or children who presented with Intra-Ventricular Hemorrhage stages 3 or 4 according to the classification of Volpe et al. or Papile et al,
- And/or children who have had a cerebral vascular accident or anoxic-ischemic encephalopathy stage 2 or 3 according to the Sarnat classification,
- And/or children who have had a so-called serious condition during the neonatal period (i.e. cardiac or visceral surgery).
Who cannot join
- Parents who are minors,
- Parents under court protection,
- Parents of children with major orthopedic or traumatic disorders unrelated to neurodevelopmental risk,
- Parents unable to understand and respond to the questionnaires to be completed.
Trial locations and contacts
1 site in 1 country.
About this study
Cerebral palsy (CP) is the leading cause of motor disability in children, affecting 125,000 people in France and with 1800 new cases per year. Prematurity remains a major risk factor, although children born at term represent 52% of children with cerebral palsy in France. Recent international and national (Haute Autorité de Santé, Troubles du neurodéveloppement - Repérage et orientation des enfants à risque, February 2020) recommendations emphasize the importance of continuous, early, and systematic management of infants at risk of cerebral palsy before 6 months of corrected age (CA), which is beneficial on the motor, cognitive, and social development of these children into preschool age. The principles of early identification and therapeutic intervention, which are at the core of multi-professional care, are becoming better known.
The priorities of this care are: the identification of high-risk infants, the continuity of follow-up from the neonatal period and after the return home in order to detect motor developmental disorders as early as possible, with a the global approach centered on the family. From the neonatal period, parents have traumatic experiences and are subjected to sources of stress. A framework of trust must be established during hospitalization, and preventive, multidisciplinary post-hospitalization follow-up is necessary. Informing families about the risks of motor developmental disorders that may affect their child and about the necessary follow-up in the first months is essential to obtain their adherence to an early course of action. This should take place even before parents have noticed abnormalities, and without waiting for a proven disability. However, it is necessary to support parents in these difficult situations by trying to reduce stress and to preserve the role of the parent.
Read more
Finally, the ESPaCe survey reveals several of the challenges faced by parents of children with CP: difficulty in finding trained therapists, low frequency of sessions, heterogeneity of rehabilitation techniques, and 75% of parents felt excluded from care and wish to be more involved. Fondation Motrice has therefore suggested developing recommendations for good clinical practice based on scientific evidence to address these difficulties.
In this context, the physiotherapists of the CHU Dijon Bourgogne have implemented the recommended early identification tools in the traditional perinatal follow-up pathway by collaborating with the neonatologists and rehabilitation physicians of the CHU Dijon Bourgogne. After the child goes home from the hospital, professionals can ensure continuity and adapt developmental support care by continuing to accompany the families. The follow-up pathway currently offered to these high-risk children includes a motor assessment at 4, 9 and 24 months of corrected age, with an additional consultation at 18 months of corrected age depending on the child's neurodevelopment. However, the psychological impact of this type of pathway on the parents, their satisfaction and their level of adherence to this care pathway are currently unknown.
Therefore, the objective of the DéStreSs study is to describe the level of parental stress and whether is varies over time, the consumption of care, parent satisfaction, and adherence to the follow-up program currently offered at the Dijon Bourgogne University Hospital.
- Conditions
- Cerebral Palsy
- Being tested
- Parenting Stress Index (PSI), Collection of health care consumption, Assessment of parent satisfaction
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Stress Index (PSI)Other
collected by self-questionnaire during the follow-up carried out within the framework of the usual care (at 4, 9, 24 months of corrected age, +/- 18 months according to the neurodevelopmental evolution).
Parental stress will be measured at each visit with the same parent (father or mother).
Collection of health care consumptionOther
Type and number of health professionals consulted between the different visits scheduled as part of the usual follow-up of the Dijon Bourgogne University Hospital,
- Frequency and duration of rehabilitation sessions by type of health professionals,
- Follow-up methods (institutional or private),
Consumption of care will be evaluated by means of self-questionnaires given to parents during follow-up consultations as part of the usual care.
Assessment of parent satisfactionOther
their level of information, their child's follow-up, and the support provided by the professionals.
Satisfaction will be evaluated by means of a self-questionnaire (Likert scale) given to parents during follow-up consultations as part of their usual care.
| Study group | Role | What they receive |
|---|---|---|
| Infants at high risk of developmental delay | Not described Receives: Other: Parenting Stress Index (PSI); Other: Collection of health care consumption; Other: Assessment of parent satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Stress Index (PSI)
Measured: throughout the visits until the child reaches 24 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start22 Apr 2022
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- 60 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
- NCT05233371
- Sponsor's protocol ID
- KRUMM 2021-2
- Acronym
- DeStreSs
- Status last verified
- Mar 2026
- First submitted
- 25 Jan 2022
- Last updated
- 19 Mar 2026
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Parental Stress and Care Consumption Until 24 Months Corrected Age of Infants at a High Risk of Developmental Delay, After Discharge From Neonatal Intensive Care
- ClinicalTrials.gov ID
- NCT05233371
- Acronym / sponsor ID
- DeStreSs / KRUMM 2021-2
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 10 Feb 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.
Cerebral palsy (CP) is the leading cause of motor disability in children, affecting 125,000 people in France and with 1800 new cases per year. Prematurity remains a major risk factor, although children born at term represent 52% of children with cerebral palsy in France. Recent international and national (Haute Autorité de Santé, Troubles du neurodéveloppement - Repérage et orientation des enfants à risque, February 2020) recommendations emphasize the importance of continuous, early, and systematic management of infants at risk of cerebral palsy before 6 months of corrected age (CA), which is beneficial on the motor, cognitive, and social development of these children into preschool age. The principles of early identification and therapeutic intervention, which are at the core of multi-professional care, are becoming better known.
The priorities of this care are: the identification of high-risk infants, the continuity of follow-up from the neonatal period and after the return home in order to detect motor developmental disorders as early as possible, with a the global approach centered on the family. From the neonatal period, parents have traumatic experiences and are subjected to sources of stress. A framework of trust must be established during hospitalization, and preventive, multidisciplinary post-hospitalization follow-up is necessary. Informing families about the risks of motor developmental disorders that may affect their child and about the necessary follow-up in the first months is essential to obtain their adherence to an early course of action. This should take place even before parents have noticed abnormalities, and without waiting for a proven disability. However, it is necessary to support parents in these difficult situations by trying to reduce stress and to preserve the role of the parent.
Finally, the ESPaCe survey reveals several of the challenges faced by parents of children with CP: difficulty in finding trained therapists, low frequency of sessions, heterogeneity of rehabilitation techniques, and 75% of parents felt excluded from care and wish to be more involved. Fondation Motrice has therefore suggested developing recommendations for good clinical practice based on scientific evidence to address these difficulties.
In this context, the physiotherapists of the CHU Dijon Bourgogne have implemented the recommended early identification tools in the traditional perinatal follow-up pathway by collaborating with the neonatologists and rehabilitation physicians of the CHU Dijon Bourgogne. After the child goes home from the hospital, professionals can ensure continuity and adapt developmental support care by continuing to accompany the families. The follow-up pathway currently offered to these high-risk children includes a motor assessment at 4, 9 and 24 months of corrected age, with an additional consultation at 18 months of corrected age depending on the child's neurodevelopment. However, the psychological impact of this type of pathway on the parents, their satisfaction and their level of adherence to this care pathway are currently unknown.
Therefore, the objective of the DéStreSs study is to describe the level of parental stress and whether is varies over time, the consumption of care, parent satisfaction, and adherence to the follow-up program currently offered at the Dijon Bourgogne University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants at high risk of developmental delay | – | Other: Parenting Stress Index (PSI), Other: Collection of health care consumption, Other: Assessment of parent satisfaction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of children at high risk of developmental delay
Key inclusion criteria (6 listed)
- Parents of children hospitalized in the neonatal unit of the CHU Dijon and meeting at least one of the criteria below:
- Premature infants ≤ 31 weeks amenorrhea + 6 days
- And/or birthweight less than 1500 g,
- And/or children who presented with Intra-Ventricular Hemorrhage stages 3 or 4 according to the classification of Volpe et al. or Papile et al,
- And/or children who have had a cerebral vascular accident or anoxic-ischemic encephalopathy stage 2 or 3 according to the Sarnat classification,
Key exclusion criteria (4 listed)
- Parents who are minors,
- Parents under court protection,
- Parents of children with major orthopedic or traumatic disorders unrelated to neurodevelopmental risk,
- Parents unable to understand and respond to the questionnaires to be completed.
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 |
|---|---|---|
| Parenting Stress Index (PSI)collected by self-questionnaire during the follow-up carried out within the framework of the usual care (at 4, 9, 24 months of corrected age, +/- 18 months according to the neurodevelopmental evolution). Parental stress will be measured at each visit with the same parent (father or mother). | Other | Infants at high risk of developmental delay |
| Collection of health care consumptionType and number of health professionals consulted between the different visits scheduled as part of the usual follow-up of the Dijon Bourgogne University Hospital, * Frequency and duration of rehabilitation sessions by type of health professionals, * Follow-up methods (institutional or private), Consumption of care will be evaluated by means of self-questionnaires given to parents during follow-up consultations as part of the usual care. | Other | Infants at high risk of developmental delay |
| Assessment of parent satisfactiontheir level of information, their child's follow-up, and the support provided by the professionals. Satisfaction will be evaluated by means of a self-questionnaire (Likert scale) given to parents during follow-up consultations as part of their usual care. | Other | Infants at high risk of developmental delay |
Primary outcome
Parenting Stress Index (PSI)
Time frame: throughout the visits until the child reaches 24 months of corrected age
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 19 Mar 2026.
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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 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 6 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 19 Mar 2026. 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?
Parenting Stress Index (PSI) (time frame: throughout the visits until the child reaches 24 months of corrected age). 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 19 Mar 2026.