Hirschsprung DiseaseHirscHADNCT06650683
Impact of Providing Nursing Support on Parental Stress Related to Preoperative Care of a Newborn with Hirschsprung's Disease
A study testing Pediatric HAH in people with Hirschsprung Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Impact of providing nursing support on parental stress related to preoperative care of a newborn with Hirschsprung's disease Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hirschsprung Disease
- What is being tested?
- Pediatric HAH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Aug 2023to 12 Feb 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Families (one or two parents) with a newborn or infant under 2 months with confirmed or suspected Hirschsprung disease, for whom nursings are effective and performed 1 to 2 times a day while waiting for surgery.
- With a possible return home before surgery
- With an information leaflet and non-opposition form signed by one or both parent(s) or by the legal representative.
Who cannot join
- The absence of daily nursings
- Initial ineffectiveness of nursings requiring a digestive stoma
- Failure to return home before surgery
- Refusal of one or both parent(s) or legal representative(s)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
APHM
Marseille
Melanie Boulanger, +33491381245, promotion.interne@ap-hm.fr
Melanie Boulanger
About this study
Impact of providing nursing support on parental stress related to preoperative care of a newborn with Hirschsprung's disease
- Conditions
- Hirschsprung Disease
- Being tested
- Pediatric HAH
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric HAHBehavioural
Pediatric HAH nursing support for home nursery care provided by parents as part of their child's disease.
| Study group | Role | What they receive |
|---|---|---|
| With Hospitalisation at Home (HAH) | Experimental | families living in Marseille, whose parents will be able to return home under the supervision of nursery nurses from the pediatric HAH. Receives: Behavioral: Pediatric HAH |
| Without Hospitalisation at Home (HAH) | No intervention | Families living outside Marseille whose parents will have to carry out nursings at home independently, without the help of pediatric HAH. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnary to evaluate stress on parents
Evaluation of the impact on parental stress of nursing support by pediatric HAH in nursery care performed at home by parents as part of their child with Hirschsprung using Perinatal Posttraumatic Stress Disorder Questionnaire (PPQ).
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (2)
Auto-Questionnary MIB (Mother Infant Bounding) to evaluate the impact of nursing support
Estimate the impact of nursing support by pediatric HAH in nursery care performed at home by parents on the development of the parent-child bond, the burden felt by parents in relation to their child's illness, the length of pre-operative hospital stay (initial and re-hospitalization), the pre-operative complications (recurrent occlusion, enterocolitis) and the home nursing care provided by parents (quality of nursings, pace of nursings, difficulties encountered, child's tolerance)
Measured: From enrollment to the end of treatment at 6 months
Self-Questionnary Burden inventory to evaluate the nursery training provided
Evaluate nursery training provided by the paramedical team (feedback from parents) : parent training (nursing, understanding illness, understanding illness-related risks) and training aids (sheet, video)
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start14 Aug 2023
- Primary completion13 Aug 2025 (estimated)
- Study completion12 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650683
- Sponsor's protocol ID
- RCAPHM22_0037
- Other IDs
- 2022-A02696-37
- Acronym
- HirscHAD
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Providing Nursing Support on Parental Stress Related to Preoperative Care of a Newborn with Hirschsprung's Disease
- ClinicalTrials.gov ID
- NCT06650683
- Acronym / sponsor ID
- HirscHAD / RCAPHM22_0037
- Conditions
- Hirschsprung Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 13 Aug 2025 (estimated)
- Study completion
- 12 Feb 2026 (estimated)
- First posted
- 21 Oct 2024 (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.
Impact of providing nursing support on parental stress related to preoperative care of a newborn with Hirschsprung's disease
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Hospitalisation at Home (HAH) | Experimental | Behavioral: Pediatric HAHfamilies living in Marseille, whose parents will be able to return home under the supervision of nursery nurses from the pediatric HAH. |
| Without Hospitalisation at Home (HAH) | No intervention | –Families living outside Marseille whose parents will have to carry out nursings at home independently, without the help of pediatric HAH. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Families (one or two parents) with a newborn or infant under 2 months with confirmed or suspected Hirschsprung disease, for whom nursings are effective and performed 1 to 2 times a day while waiting for surgery.
- With a possible return home before surgery
- With an information leaflet and non-opposition form signed by one or both parent(s) or by the legal representative.
Key exclusion criteria (4 listed)
- The absence of daily nursings
- Initial ineffectiveness of nursings requiring a digestive stoma
- Failure to return home before surgery
- Refusal of one or both parent(s) or legal representative(s)
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 |
|---|---|---|
| Pediatric HAHPediatric HAH nursing support for home nursery care provided by parents as part of their child's disease. | Behavioural | With Hospitalisation at Home (HAH) |
Primary outcome
Questionnary to evaluate stress on parents
Time frame: From enrollment to the end of treatment at 6 months
Evaluation of the impact on parental stress of nursing support by pediatric HAH in nursery care performed at home by parents as part of their child with Hirschsprung using Perinatal Posttraumatic Stress Disorder Questionnaire (PPQ).
2 secondary outcomes
Auto-Questionnary MIB (Mother Infant Bounding) to evaluate the impact of nursing support
Time frame: From enrollment to the end of treatment at 6 months
Self-Questionnary Burden inventory to evaluate the nursery training provided
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric HAH in people with Hirschsprung Disease, run by Assistance Publique Hopitaux De Marseille 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: status not confirmed, as of the sponsor's last update on 21 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie Boulanger (+33491381245, promotion.interne@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnary to evaluate stress on parents (time frame: From enrollment to the end of treatment at 6 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 21 Oct 2024.