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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • CHU Dijon Bourgogne

    Dijon

Other trials in France

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 groups in NCT05233371
Study groupRoleWhat they receive
Infants at high risk of developmental delayNot 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.

  1. 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.

  1. First posted10 Feb 2022
  2. Study start22 Apr 2022
  3. Primary completion13 Mar 2025
  4. Study completion13 Mar 2025

Resources

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)
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

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.

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