PrematurePREMATACTNCT06365164
Study of the Emergence of Sensory Self-awareness in Premature Newborns Using the Rooting Reflex
An observational study of Premature and Development, Child, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness. Read more about this study
- Who is it for?
- Ages 28 to 37 weeks
- Conditions the study is for
- Premature, Development, Child, Rooting Reflex
- What is being tested?
- Tactile stimulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2024to Nov 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 28 to 37 weeks
- All sexes
- Child
Study population: Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days.
Who may be able to join
- Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days.
Who cannot join
- respiratory assistance (invasive or non-invasive ventilation)
- malformative syndrome
- a genetic syndrome
- neurological damage such as stage III or IV intraventricular haemorrhage or periventricular leukomalacia,
- sedative treatment: morphine, clonidine
- aminergic treatment
- acute pathology: shock, sepsis, acute cardiac failure, acute respiratory failure, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Presence of the Rooting Reflex on Preterms' ? Study of the Emergence of Sensory Self-awareness in Premature Newborns: Comparison of the Rooting Reflex Response Between Facilitated Self-stimulation and External Stimulation
The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness.
The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness.
The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn.
Read the detailed description
Touch is the first sense to develop in foetal life. Children born prematurely have early tactile skills, in particular the ability to discriminate and learn. These tactile skills can be expressed through the newborn's reflexes. The sensory exploration that takes place when reflexes are manifested can be the basis for tactile learning and, in particular, for the development of the baby's awareness of his own body, with discrimination of the self. As touch plays an essential role in the child's perceptual-cognitive development, studying the tactile skills of premature infants is an ideal approach for a better understanding of the development of primitive sensory awareness.
The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness, by comparing the response of the rooting reflex between facilitated self-stimulation and external stimulation.
The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn.
The study of the specific sensory of the premature newborn is part of the continuum of developmental care, and is part of an approach to improving the care delivered in neonatology with the aim of encouraging the best neurological development.
- Conditions
- Premature, Development, Child, Rooting Reflex
- Being tested
- Tactile stimulation
- Keywords
- rooting reflex, sensory self-awareness, tactile sensory, premature newborn, development care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile stimulationBehavioural
The procedure consists of brief perioral tactile stimulation. The procedure is filmed in order to record and evaluate the response of the newborn to the stimulation. During the same intervention, each newborn will receive external stimulation (the experimenter repeatedly and regularly touches the corner of the infant's mouth slowly with the tip of his index finger) followed by facilitated self-stimulation (the experimenter will place the newborn's elbow close to his body, allowing him to touch his face alone with his hand). There will also be an initial phase and a final 30-second phase in which the newborn is observed without any stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Premature newborns | Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days. Receives: Behavioral: Tactile stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening.
First the external stimulation procedure is 30-second phase of observation. Next, the experimenter touches the corner of the infant's mouth and repeatedly with his index finger (about 5 gentle touches of about 10 seconds, repeated about 5 times) depending on the state and commitment of the newborn, ending with a final observation period of 30 seconds.
The facilitated self-stimulation procedure will begin and end with a 30-second observation period. Then the experimenter will place the newborn's elbow close to his body, allowing him to touch his face alone with his hand, on one side then the other, for 30 seconds, with 2 to 5 trials depending on the child's level of commitment.
The coding use a qualitative scale of four behaviours from 1 to 4 that are increasingly representative of the rooting reflex. The primary outcome is defined by an average score of the relative frequencies representative of the rooting reflex and will be compared between the two stimulation conditions.
Measured: The data will be collected for one year. Each newborn baby can be included for 14 weeks.The intervention is 5 to 10 minutes corresponding to external stimulation and facilitated self-stimulation spaced at least 2 hours apart and for up to 48 hours.
Secondary outcomes (1)
The secondary objective is to show a longitudinal progression in the emergence of the rooting reflex by repeated inclusions (seven days minimum) at different terms for the same newborn.
After inclusion, each subject will be able to take part in up to three interventions, each at least 7 days apart, until they reach 41 weeks' gestation.The investigators will use a qualitative scale of four behaviours from 1 to 4 that are increasingly representative of the rooting reflex :
- outward movement of the head
- movement of the head towards the stimulation
- movement of the head towards facial stimulation with the mouth open
- head movement towards facial stimulation with tongue protrusion. The fourth behaviour corresponds to the most complete rooting reflex, and is the highest score.
For each newborn, the relative frequency of each of the four behaviours described above as gradually representative of the expression of the rooting reflex in the same newborn will be compared at different terms and according to the type of stimulation.
Measured: Each subject will be able to take part in up to three interventions, each at least 7 days apart, until they reach 41 weeks' gestation. The data will be collected for one year. Each newborn baby can be included for 14 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Sponsor
- Investigators
- Julia Doutau, Principal investigator, University Grenoble Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365164
- Sponsor's protocol ID
- 38RC23.0354
- Acronym
- PREMATACT
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lejeune F, Marcus L, Berne-Audeoud F, Streri A, Debillon T, Gentaz E. Intermanual transfer of shapes in preterm human infants from 33 to 34 + 6 weeks postconceptional age. Child Dev. 2012 May-Jun;83(3):794-800. doi: 10.1111/j.1467-8624.2012.01753.x. Epub 2012 Mar 30.
PubMed 22469180Marcus L, Lejeune F, Berne-Audeoud F, Gentaz E, Debillon T. Tactile sensory capacity of the preterm infant: manual perception of shape from 28 gestational weeks. Pediatrics. 2012 Jul;130(1):e88-94. doi: 10.1542/peds.2011-3357. Epub 2012 Jun 25.
PubMed 22732168Als H, McAnulty GB. The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) with Kangaroo Mother Care (KMC): Comprehensive Care for Preterm Infants. Curr Womens Health Rev. 2011 Aug;7(3):288-301. doi: 10.2174/157340411796355216.
PubMed 25473384
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of the Rooting Reflex on Preterms' ? Study of the Emergence of Sensory Self-awareness in Premature Newborns: Comparison of the Rooting Reflex Response Between Facilitated Self-stimulation and External Stimulation
- ClinicalTrials.gov ID
- NCT06365164
- Acronym / sponsor ID
- PREMATACT / 38RC23.0354
- Conditions
- Premature, Development, Child, Rooting Reflex
- Keywords
- rooting reflex, sensory self-awareness, tactile sensory, premature newborn, development care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- Jun 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 15 Apr 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.
The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness.
The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness.
The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn.
Detailed description
Touch is the first sense to develop in foetal life. Children born prematurely have early tactile skills, in particular the ability to discriminate and learn. These tactile skills can be expressed through the newborn's reflexes. The sensory exploration that takes place when reflexes are manifested can be the basis for tactile learning and, in particular, for the development of the baby's awareness of his own body, with discrimination of the self. As touch plays an essential role in the child's perceptual-cognitive development, studying the tactile skills of premature infants is an ideal approach for a better understanding of the development of primitive sensory awareness.
The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness, by comparing the response of the rooting reflex between facilitated self-stimulation and external stimulation.
The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn.
The study of the specific sensory of the premature newborn is part of the continuum of developmental care, and is part of an approach to improving the care delivered in neonatology with the aim of encouraging the best neurological development.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature newborns | – | Behavioral: Tactile stimulationChildren born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Age groups
- Child
- Study population
- Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days.
Key inclusion criteria (1 listed)
- Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days.
Key exclusion criteria (7 listed)
- respiratory assistance (invasive or non-invasive ventilation)
- malformative syndrome
- a genetic syndrome
- neurological damage such as stage III or IV intraventricular haemorrhage or periventricular leukomalacia,
- sedative treatment: morphine, clonidine
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 |
|---|---|---|
| Tactile stimulationThe procedure consists of brief perioral tactile stimulation. The procedure is filmed in order to record and evaluate the response of the newborn to the stimulation. During the same intervention, each newborn will receive external stimulation (the experimenter repeatedly and regularly touches the corner of the infant's mouth slowly with the tip of his index finger) followed by facilitated self-stimulation (the experimenter will place the newborn's elbow close to his body, allowing him to touch his face alone with his hand). There will also be an initial phase and a final 30-second phase in which the newborn is observed without any stimulation. | Behavioural | Premature newborns |
Primary outcome
The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening.
Time frame: The data will be collected for one year. Each newborn baby can be included for 14 weeks.The intervention is 5 to 10 minutes corresponding to external stimulation and facilitated self-stimulation spaced at least 2 hours apart and for up to 48 hours.
First the external stimulation procedure is 30-second phase of observation. Next, the experimenter touches the corner of the infant's mouth and repeatedly with his index finger (about 5 gentle touches of about 10 seconds, repeated about 5 times) depending on the state and commitment of the newborn, ending with a final observation period of 30 seconds. The facilitated self-stimulation procedure will begin and end with a 30-second observation period. Then the experimenter will place the newborn's elbow close to his body, allowing him to touch his face alone with his hand, on one side then the other, for 30 seconds, with 2 to 5 trials depending on the child's level of commitment. The coding use a qualitative scale of four behaviours from 1 to 4 that are increasingly representative of the rooting reflex. The primary outcome is defined by an average score of the relative frequencies representative of the rooting reflex and will be compared between the two stimulation conditions.
1 secondary outcome
The secondary objective is to show a longitudinal progression in the emergence of the rooting reflex by repeated inclusions (seven days minimum) at different terms for the same newborn.
Time frame: Each subject will be able to take part in up to three interventions, each at least 7 days apart, until they reach 41 weeks' gestation. The data will be collected for one year. Each newborn baby can be included for 14 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Background: PubMed 22469180Lejeune F, Marcus L, Berne-Audeoud F, Streri A, Debillon T, Gentaz E. Intermanual transfer of shapes in preterm human infants from 33 to 34 + 6 weeks postconceptional age. Child Dev. 2012 May-Jun;83(3):794-800. doi: 10.1111/j.1467-8624.2012.01753.x. Epub 2012 Mar 30.
- Background: PubMed 22732168Marcus L, Lejeune F, Berne-Audeoud F, Gentaz E, Debillon T. Tactile sensory capacity of the preterm infant: manual perception of shape from 28 gestational weeks. Pediatrics. 2012 Jul;130(1):e88-94. doi: 10.1542/peds.2011-3357. Epub 2012 Jun 25.
- Background: PubMed 25473384Als H, McAnulty GB. The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) with Kangaroo Mother Care (KMC): Comprehensive Care for Preterm Infants. Curr Womens Health Rev. 2011 Aug;7(3):288-301. doi: 10.2174/157340411796355216.
- Touch in premature newbornsLink provided by the sponsor.
- 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.
Julia Doutau principal investigator
University Grenoble Hospital
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 and Development, Child, 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 7 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 15 Apr 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 Julia Doutau, Doctor (0476765577, jdoutau@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening. (time frame: The data will be collected for one year. Each newborn baby can be included for 14 weeks.The intervention is 5 to 10 minutes corresponding to external stimulation and facilitated self-stimulation spaced at least 2 hours apart and for up to 48 hours.). 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 NCT06365164, which also lists 3 linked publications.
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 15 Apr 2024.