Premature BirthPARENNCT06811064
Involving Family Stakeholders in the NICU: a New Perspective to Improve Quality of Life. PAREN
An observational study of Premature Birth, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Introduction Thanks to medical advances in neonatal care, the majority of children admitted to the neonatal intensive care unit (NICU) survive and enjoy a good quality of life. At the same time, medical practices and philosophy of neonatal care have changed and families are playing an increasingly important role in… Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Premature Birth
- What is being tested?
- Testimony video
- How many people
- 1,008 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2025to 29 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: premature newborn
Who may be able to join
- Premature newborn (<37 weeks of amenorrhoea)
- Newborn whose parents are aged 18 or over
- Newborns who have spent at least one week in a neonatal intensive care unit,
- Newborn baby hospitalised in one of the neonatology/intensive care unit
- Newborn for whom both or one of the two parents have expressed their non-opposition to taking part in the study or Newborn for whom the only legal representative (single-parent family) has expressed his/her non-opposition to taking part in the study.
Who cannot join
- Newborns at term (≥ 37 SA);
- Newborns in which both or one of the parents refuse to participate or newborns in which the only legal representative (single-parent family) has expressed opposition to participating in the study.
- Newborn whose two parents or one of them withdraws their non-opposition
- Newborn transferred to another neonatal intensive care unit during hospital stay;
- Newborn child who dies during hospitalisation or after discharge up to the one-year visit.
- Newborn lost to follow-up at 1 year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Claire MORANDO, MD contact
France1 site
Assistance Publique des Hôpitaux de Marseille (APHM)
Marseille, 13015
Barthélémy TOSELLO, MD, PhD, 4 91 96 83 00 ext. +33, barthelemy.tosello@ap-hm.fr
About this study
Official title: Resource Parents in Neonatology: Innovative Partnership Practices to Improve Quality of Life After Returning Home
Introduction Thanks to medical advances in neonatal care, the majority of children admitted to the neonatal intensive care unit (NICU) survive and enjoy a good quality of life. At the same time, medical practices and philosophy of neonatal care have changed and families are playing an increasingly important role in their child's care. However, stress and anxiety generated by hospitalization and complex technologies of neonatal intensive care units may be an obstacle to integrate parents and help them take ownership of their role. A number of measures have been established to improve the experience of parents in neonatology, such as multidisciplinary care, involving psychologists, social workers, spiritual care workers, psychomotor therapists and physiotherapists.
Among these interventions, the introduction of resource parents (RPs), parents who have previously been involved in neonatology, is a new initiative that is growing rapidly in North America. These RPs bring a unique perspective based on their experiential knowledge. This partnership model is still underdeveloped in France, and its impact on parents' quality of life and early interactions with their children has been little studied or described.
Read more
Method Our aim is therefore to develop a PR intervention in neonatology units and measure its impact in the short and medium term, with a prospective multicenter step wedge study.
The chosen intervention will be co-constructed with PRs. It will take the form of testimonial videos focusing on one of the key moments in the care of newborn babies: the transition from different neonatology units. These videos will then be viewed by parents of hospitalized newborn in the units at the time of their transition. A survey assessing the parents' Self Perceived Efficacity in taking care of their child will be administered when the child transitions to the neonatal unit and then again when the child is discharged from the hospital. At the one-year old visit, the families' quality of life will be assessed using another standardized survey: the Pediatric Quality of Life Inventory (PedsQLTM2.0) - Family Impact Module.
Perspective Our hypothesis is that a PR intervention at a key point in the newborn's care pathway can help parenthood and have a positive impact on early interactions and quality of life at 1 year.
- Conditions
- Premature Birth
- Being tested
- Testimony video
- Keywords
- resource parents, quality of life, premature newborn, neonatal intensive care unit
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testimony videoOther
A testimonial video on the experiences of parents of premature babies during the transfer of their newborn from the intensive care unit to the neonatal unit. This video will be performed with the collaboration of the carers and resource parents.
| Study group | Role | What they receive |
|---|---|---|
| Intervention of resource parents for parents of hospitalised premature new born | Parents of hospitalised premature new born watch a testimony video pf other parent who experienced hospitalization of their premature new born Receives: Other: Testimony video | |
| without intervention of resource parents for parents of hospitalised premature new born | Parents of hospitalised premature new born do not watch a testimony video of other parent who experienced hospitalization of their premature new born |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the the quality of life of parent with premature child at one year corrected age
Questionnaire PedsQL
Measured: At the one year anniversary (12 months corrected age) of the premature child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start30 Sep 2025 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,008 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde LEFEVRE, Study director, assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811064
- Sponsor's protocol ID
- 2022-A01087-36
- Acronym
- PAREN
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 6 Feb 2025
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resource Parents in Neonatology: Innovative Partnership Practices to Improve Quality of Life After Returning Home
- ClinicalTrials.gov ID
- NCT06811064
- Acronym / sponsor ID
- PAREN / 2022-A01087-36
- Conditions
- Premature Birth
- Keywords
- resource parents, quality of life, premature newborn, neonatal intensive care unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,008 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 6 Feb 2025 (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.
Introduction Thanks to medical advances in neonatal care, the majority of children admitted to the neonatal intensive care unit (NICU) survive and enjoy a good quality of life. At the same time, medical practices and philosophy of neonatal care have changed and families are playing an increasingly important role in their child's care. However, stress and anxiety generated by hospitalization and complex technologies of neonatal intensive care units may be an obstacle to integrate parents and help them take ownership of their role. A number of measures have been established to improve the experience of parents in neonatology, such as multidisciplinary care, involving psychologists, social workers, spiritual care workers, psychomotor therapists and physiotherapists.
Among these interventions, the introduction of resource parents (RPs), parents who have previously been involved in neonatology, is a new initiative that is growing rapidly in North America. These RPs bring a unique perspective based on their experiential knowledge. This partnership model is still underdeveloped in France, and its impact on parents' quality of life and early interactions with their children has been little studied or described.
Method Our aim is therefore to develop a PR intervention in neonatology units and measure its impact in the short and medium term, with a prospective multicenter step wedge study.
The chosen intervention will be co-constructed with PRs. It will take the form of testimonial videos focusing on one of the key moments in the care of newborn babies: the transition from different neonatology units. These videos will then be viewed by parents of hospitalized newborn in the units at the time of their transition. A survey assessing the parents' Self Perceived Efficacity in taking care of their child will be administered when the child transitions to the neonatal unit and then again when the child is discharged from the hospital. At the one-year old visit, the families' quality of life will be assessed using another standardized survey: the Pediatric Quality of Life Inventory (PedsQLTM2.0) - Family Impact Module.
Perspective Our hypothesis is that a PR intervention at a key point in the newborn's care pathway can help parenthood and have a positive impact on early interactions and quality of life at 1 year.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention of resource parents for parents of hospitalised premature new born | – | Other: Testimony videoParents of hospitalised premature new born watch a testimony video pf other parent who experienced hospitalization of their premature new born |
| without intervention of resource parents for parents of hospitalised premature new born | – | –Parents of hospitalised premature new born do not watch a testimony video of other parent who experienced hospitalization of their premature new born |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- premature newborn
Key inclusion criteria (5 listed)
- Premature newborn (<37 weeks of amenorrhoea)
- Newborn whose parents are aged 18 or over
- Newborns who have spent at least one week in a neonatal intensive care unit,
- Newborn baby hospitalised in one of the neonatology/intensive care unit
- Newborn for whom both or one of the two parents have expressed their non-opposition to taking part in the study or Newborn for whom the only legal representative (single-parent family) has expressed his/her non-opposition to taking part in the study.
Key exclusion criteria (6 listed)
- Newborns at term (≥ 37 SA);
- Newborns in which both or one of the parents refuse to participate or newborns in which the only legal representative (single-parent family) has expressed opposition to participating in the study.
- Newborn whose two parents or one of them withdraws their non-opposition
- Newborn transferred to another neonatal intensive care unit during hospital stay;
- Newborn child who dies during hospitalisation or after discharge up to the one-year visit.
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 |
|---|---|---|
| Testimony videoA testimonial video on the experiences of parents of premature babies during the transfer of their newborn from the intensive care unit to the neonatal unit. This video will be performed with the collaboration of the carers and resource parents. | Other | Intervention of resource parents for parents of hospitalised premature new born |
Primary outcome
Evaluate the the quality of life of parent with premature child at one year corrected age
Time frame: At the one year anniversary (12 months corrected age) of the premature child
Questionnaire PedsQL
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- 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.
Claire MORANDO, MD contact
Mathilde LEFEVRE study director
assistance Publique Hôpitaux de Marseille
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 Premature Birth, 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barthélémy TOSELLO, MD, PhD (04 91 96 83 00 ext. + 33, barthelemy.tosello@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the the quality of life of parent with premature child at one year corrected age (time frame: At the one year anniversary (12 months corrected age) of the premature child). 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 6 Feb 2025.