Premature NewbornEMMASENSNCT04315428
Study of Swaddling on Tactile Learning in Premature Infants
An observational study of Premature Newborn, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Explore the sensorially of the premature newborn that is fundamental to adapting the care environment to these hospitalized babies Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Newborn
- What is being tested?
- swaddling and no swaddling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2018to 23 May 2019
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children born prematurely and hospitalized in the neonatal and neonatal resuscitation unit at the University Hospital of Grenoble
Who may be able to join
- Children born prematurely and aged 28 to 35 Weeks of Amenorrhoea, regardless of their postnatal age
Who cannot join
- premature newborns with
- associated anomalies syndrome
- abnormal cranial ultrasonography with stage III or IV intraventricular hemorrhage or periventricular cavitary leukaemia
- those receiving sedative or convulsive treatment during the experiment
- those whose grasping reflex is absent
Trial locations and contacts
1 site in 1 country.
About this study
Explore the sensorially of the premature newborn that is fundamental to adapting the care environment to these hospitalized babies
Read the detailed description
Indeed, the challenge is to offer them an environment adapted to their sensory skills, so as not to alter their development.
This is in line with the customized care development, better known as the Anglo-Saxon term of Neonatal Individualised Developmental Care and Assessment Program.
The aim is thus to promote later the cognitive development of these children
- Conditions
- Premature Newborn
- Being tested
- swaddling, no swaddling
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swaddlingBehavioural
The two experimenters together evaluate the child's state of awakening throughout the experiment. If the child is considered by both experimenters to be too restless or too sleepy, the experiment is immediately stopped and postponed
no swaddlingBehavioural
The two experimenters together evaluate the child's state of awakening throughout the experiment. If the child is considered by both experimenters to be too restless or too sleepy, the experiment is immediately stopped and postponed
| Study group | Role | What they receive |
|---|---|---|
| premature swaddled | the childs in this group will be wrap in a lange (swaddled) Receives: Behavioral: swaddling | |
| premature no swaddled | the childs in this group will be not swaddled Receives: Behavioral: no swaddling |
What is being measured
The primary outcome is the main question the study is designed to answer.
time required to habituate a first object (corresponding to a time when the object is held repeatedly) and time required to present a new object (corresponding to the property of discrimination)
time required to habituate a first object (corresponding to a time when the object is held repeatedly) and time required to present a new object (corresponding to the property of discrimination)
Measured: up to 3 months max
Secondary outcomes (1)
Compare cognitive development at 2 years in both groups
Global development quotient, derived from the Brunet-Lezine scale, (performed systematically as part of the normal follow-up of premature babies in the N\&D care network).
the Brunet-Lezine scale : it is a global development quotient (QD) which is calculated and which corresponds to a standardized score (average of 100). Higher score corresponds to better child development
Measured: between first evaluation and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start12 Dec 2018
- Primary completion23 May 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature NewbornStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- GeneveUniversity
- Responsible party
- Sponsor
- Investigators
- Leïla MARCUS, Dr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315428
- Sponsor's protocol ID
- 38RC18.060
- Acronym
- EMMASENS
- Status last verified
- Mar 2020
- First submitted
- 19 Dec 2019
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lejeune F, Delacroix E, Gentaz E, Berne-Audeoud F, Marcus L, Debillon T. Influence of swaddling on tactile manual learning in preterm infants. Early Hum Dev. 2021 Feb;153:105288. doi: 10.1016/j.earlhumdev.2020.105288. Epub 2020 Dec 3.
PubMed 33291020
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Swaddling on Tactile Learning in Premature Infants
- ClinicalTrials.gov ID
- NCT04315428
- Acronym / sponsor ID
- EMMASENS / 38RC18.060
- Conditions
- Premature Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- GeneveUniversity
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 19 Mar 2020 (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.
Explore the sensorially of the premature newborn that is fundamental to adapting the care environment to these hospitalized babies
Detailed description
Indeed, the challenge is to offer them an environment adapted to their sensory skills, so as not to alter their development.
This is in line with the customized care development, better known as the Anglo-Saxon term of Neonatal Individualised Developmental Care and Assessment Program.
The aim is thus to promote later the cognitive development of these children
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premature swaddled | – | Behavioral: swaddlingthe childs in this group will be wrap in a lange (swaddled) |
| premature no swaddled | – | Behavioral: no swaddlingthe childs in this group will be not swaddled |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children born prematurely and hospitalized in the neonatal and neonatal resuscitation unit at the University Hospital of Grenoble
Key inclusion criteria (1 listed)
- Children born prematurely and aged 28 to 35 Weeks of Amenorrhoea, regardless of their postnatal age
Key exclusion criteria (5 listed)
- premature newborns with
- associated anomalies syndrome
- abnormal cranial ultrasonography with stage III or IV intraventricular hemorrhage or periventricular cavitary leukaemia
- those receiving sedative or convulsive treatment during the experiment
- those whose grasping reflex is absent
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 |
|---|---|---|
| swaddlingThe two experimenters together evaluate the child's state of awakening throughout the experiment. If the child is considered by both experimenters to be too restless or too sleepy, the experiment is immediately stopped and postponed | Behavioural | premature swaddled |
| no swaddlingThe two experimenters together evaluate the child's state of awakening throughout the experiment. If the child is considered by both experimenters to be too restless or too sleepy, the experiment is immediately stopped and postponed | Behavioural | premature no swaddled |
Primary outcome
time required to habituate a first object (corresponding to a time when the object is held repeatedly) and time required to present a new object (corresponding to the property of discrimination)
Time frame: up to 3 months max
time required to habituate a first object (corresponding to a time when the object is held repeatedly) and time required to present a new object (corresponding to the property of discrimination)
1 secondary outcome
Compare cognitive development at 2 years in both groups
Time frame: between first evaluation and 2 years
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 2020.
- Derived from this study: PubMed 33291020Lejeune F, Delacroix E, Gentaz E, Berne-Audeoud F, Marcus L, Debillon T. Influence of swaddling on tactile manual learning in preterm infants. Early Hum Dev. 2021 Feb;153:105288. doi: 10.1016/j.earlhumdev.2020.105288. Epub 2020 Dec 3.
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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.
Leïla MARCUS, Dr principal investigator
University Hospital, Grenoble
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 Newborn, run by University Hospital, Grenoble 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 1 inclusion and 5 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 2020. 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?
time required to habituate a first object (corresponding to a time when the object is held repeatedly) and time required to present a new object (corresponding to the property of discrimination) (time frame: up to 3 months max). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315428, which also lists 1 linked publication.
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 2020.