Infant, Newborn, DiseasePAPSENCT04034719
Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home
A study testing portage scarf and usual practice in people with Infant, Newborn, Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. Read more about this study
- Who is it for?
- Ages Up to 10 weeks
- Conditions the study is for
- Infant, Newborn, Disease
- What is being tested?
- portage scarf and usual practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2019to 22 Mar 2022
- 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 Up to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For the child:
- Any newborn regardless of gestational age and postnatal age hospitalized in the neonatology department of the University Hospital of Saint-Etienne
- For the parent (father or mother):
- Be a parent of a child eligible for the research protocol
Who cannot join
- For the child:
- Need for sedation or analgesia for the duration of the study
- Orthopedic pathology incompatible with the practice of carrying
- Other medical contraindications to carriage
- Absence of parents
- For the parent (father or mother):
- Family, social or psychological situation compromising the evaluation
- No fluency in the French language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home(PAPSE)
Carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. Carrying is also a growing brain protection technique and becomes a routine of care in all neonatal units around the world.
In University hospital of Saint-Etienne, the developmental care program has been developed since 2002 in all neonatology units and advocates the practice of skin-to-skin carrying between the parent (father or mother) and his baby, from the time of the hospitalization. Professionals in units who have long been thinking about the concept of attachment and the benefits of skin-to-skin, wish to validate the use of the wearing scarf as a tool for the practice of skin -in-skin in neonatology then back home by performing a randomized monocentric prospective longitudinal study.
Read the detailed description
This study it's a single-center, prospective, randomized study to evaluate the benefit of the scarf in the practice of skin-to-skin and portage (PAPSE Group) compared to a Skin-to-Skin and Carry Without Scarf (PAP group).
- Conditions
- Infant, Newborn, Disease
- Being tested
- portage scarf, usual practice
- Keywords
- Newborn, Parents, Carrying, Skin-to-skin, Scarf
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portage scarfOther
Parents will be carried their newborn with the portage scarf provided by the department.
usual practiceOther
Parents will be carried their newborn as their usual practice.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Newborn hospitalized in the neonatal department with their parent will be included.
They will have a portage scarf to help them to keep their child skin-to-skin Receives: Other: portage scarf |
| Control group | Active comparator | Newborn hospitalized in the neonatal department with their parent will be included.
They wont have a portage scarf. Receives: Other: usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of minuts with portage skin-to-skin
Measured in minutes by the time sheet of presence.
Measured: From inclusion to 2 months after exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start8 Oct 2019
- Primary completion18 Oct 2021
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Newborn, DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues PATURAL, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034719
- Sponsor's protocol ID
- 19CH089
- Other IDs
- 2019-A01113-54
- Acronym
- PAPSE
- Status last verified
- Jan 2022
- First submitted
- 23 Jul 2019
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home(PAPSE)
- ClinicalTrials.gov ID
- NCT04034719
- Acronym / sponsor ID
- PAPSE / 19CH089
- Conditions
- Infant, Newborn, Disease
- Keywords
- Newborn, Parents, Carrying, Skin-to-skin, Scarf
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 26 Jul 2019 (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.
Carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. Carrying is also a growing brain protection technique and becomes a routine of care in all neonatal units around the world.
In University hospital of Saint-Etienne, the developmental care program has been developed since 2002 in all neonatology units and advocates the practice of skin-to-skin carrying between the parent (father or mother) and his baby, from the time of the hospitalization. Professionals in units who have long been thinking about the concept of attachment and the benefits of skin-to-skin, wish to validate the use of the wearing scarf as a tool for the practice of skin -in-skin in neonatology then back home by performing a randomized monocentric prospective longitudinal study.
Detailed description
This study it's a single-center, prospective, randomized study to evaluate the benefit of the scarf in the practice of skin-to-skin and portage (PAPSE Group) compared to a Skin-to-Skin and Carry Without Scarf (PAP group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: portage scarfNewborn hospitalized in the neonatal department with their parent will be included. They will have a portage scarf to help them to keep their child skin-to-skin |
| Control group | Active comparator | Other: usual practiceNewborn hospitalized in the neonatal department with their parent will be included. They wont have a portage scarf. |
Who may qualify
- Ages
- Up to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Any newborn regardless of gestational age and postnatal age hospitalized in the neonatology department of the University Hospital of Saint-Etienne
- Be a parent of a child eligible for the research protocol
Key exclusion criteria (8 listed)
- Need for sedation or analgesia for the duration of the study
- Orthopedic pathology incompatible with the practice of carrying
- Other medical contraindications to carriage
- Absence of parents
- Family, social or psychological situation compromising the evaluation
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 |
|---|---|---|
| portage scarfParents will be carried their newborn with the portage scarf provided by the department. | Other | Experimental group |
| usual practiceParents will be carried their newborn as their usual practice. | Other | Control group |
Primary outcome
Number of minuts with portage skin-to-skin
Time frame: From inclusion to 2 months after exit
Measured in minutes by the time sheet of presence.
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 24 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Hugues PATURAL, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing portage scarf and usual practice in people with Infant, Newborn, Disease, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 8 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 24 Aug 2022. 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?
Number of minuts with portage skin-to-skin (time frame: From inclusion to 2 months after exit). 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 24 Aug 2022.