Premature BirthPREMATEMPNCT02880696
Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates
A study testing Regular stimulation sequence, Random stimulation sequence and DCS in people with Premature Birth, run by University Hospital, Caen.
Trial summary
A key function of our brain is to identify temporal structures in the environment and use them to form expectations. These expectations allow us to plan and organize our behavior towards changes in the environment, and optimize the use of our attentional and motor resources. Read more about this study
- Who is it for?
- Ages Up to 6 daysHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Regular stimulation sequence, Random stimulation sequence and DCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jul 2018
- 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 6 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 40 premature infants born to SA 31 + 0 days to 32 weeks + 6 days , hospitalized in the neonatal unit of the University Hospital of Caen
Who cannot join
- Suspected neurological disorder (grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia), or motor condition that might interfere with tactile perception on the hand
- Intubation or CPAP
- Viral of bacterial infection
- Sedation at the time of measurement
- Parent(s) who are minor or unable to give free and informed consent
- No consent from the parents
- Non-inclusion request by the child's neonatologist
Trial locations and contacts
No sites are listed yet.
About this study
A key function of our brain is to identify temporal structures in the environment and use them to form expectations. These expectations allow us to plan and organize our behavior towards changes in the environment, and optimize the use of our attentional and motor resources. They also allow us to establish harmonious social interactions, coordinating us with our interlocutor during an exchange. Our ability to form temporal expectations seems to emerge very early but the development of this process is unknown. We only know that a set of basic skills, probably related to that ability, are present from birth. This suggests that temporal processing capabilities emerge during the prenatal period, but this has not been studied. The objective of this project is to study preterm infants brain's ability to process the intervals between stimuli and to form expectations on that basis.
Read the detailed description
40 patients (20 per group) : Presence of a functional response to stimulus omissions, only in the test group (regular presentation).
Group 1 will receive the test stimulation sequence (regular), Group 2 will receive the control stimulation sequence (random).
During the test sequence, a vibration will be repeated for 3 s interspersed with intervals of 5 s, creating an expectation about the presentation of the next stimulus. Every 8 to 12 vibrations (random), a vibration will be omitted. According to our hypothesis, we should observe an activity in the somatosensory cortex during the omission. A total of 10 omissions will be presented, bringing the total duration of stimulus presentation to 13 minutes.
During the control sequence, the interstimulus intervals are irregular, 3 to 7 seconds, so as not to induce expectations. Omissions in this case should not be associated with a functional brain response.
The presence of an activation in the primary somatosensory cortex will be assessed using Diffuse Correlation Spectroscopy (DCS), on newborns of 32, 33 and 35 weeks of corrected gestational age, during omissions in a regular vibrotactile stimulation sequence (test group) with respect to an irregular sequence (control group). A difference in activation during omissions between groups will reflect the presence of a processing of time intervals at the cortical level.
We will also assess the difference in amplitude and time to peak of the response between the corrected gestational ages and vigilance states.
Main endpoint: amplitude of the neurovascular response significantly higher and / or time to peak significantly shorter during the omissions in the test group (regular sequence) compared to the control group (irregular sequence), evaluated twice: at ages corrected SA 33 ± 3 days and 35 weeks ± 3 days , and if possible SA 32 ± 3 days (optional measure depending on the gestational age at birth and time to obtain consent).
Secondary endpoints: significant difference in amplitude and / or time to peak of the neurovasculat response between corrected gestational ages and vigilance states.
- Conditions
- Premature Birth
- Being tested
- Regular stimulation sequence, Random stimulation sequence, DCS
- Keywords
- Time Perception, Tactile Perception, Spectroscopy, Near-Infrared
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular stimulation sequenceBehavioural
Vibrotactile stimulation of the right hand with regular intervals and random omissions
Random stimulation sequenceBehavioural
Vibrotactile stimulation of the right hand with random intervals and random omissions
DCSDevice
Also called Diffuse correlation spectroscopy
Near-infrared imaging of the neurovascular response in the left somatosensory cortex
| Study group | Role | What they receive |
|---|---|---|
| Test (Regular) | Experimental | Regular stimulation sequence \& DCS Receives: Behavioral: Regular stimulation sequence; Device: DCS |
| Control (Random) | Active comparator | Random stimulation sequence \& DCS Receives: Behavioral: Random stimulation sequence; Device: DCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of the primary somatosensory cortex during stimulation omissions
Measured: Between 32 and 35 week of corrected gestational age
Secondary outcomes (2)
Change in amplitude or time to peak of the response as a function of age
Measured: Between 32 and 35 week of corrected gestational age
Change in amplitude or time to peak of the response with age as a function of vigilance state
Measured: Between 32 and 35 week of corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2018 (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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Caen Normandie
- Responsible party
- Sponsor
- Investigators
- Nadège RN Roche-Labarbe, PhD, Study chair, Université Caen Normandie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880696
- Sponsor's protocol ID
- 2014-A01762-45
- Acronym
- PREMATEMP
- Status last verified
- May 2016
- First submitted
- 9 Feb 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates
- ClinicalTrials.gov ID
- NCT02880696
- Acronym / sponsor ID
- PREMATEMP / 2014-A01762-45
- Conditions
- Premature Birth
- Keywords
- Time Perception, Tactile Perception, Spectroscopy, Near-Infrared
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Université de Caen Normandie
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 26 Aug 2016 (estimated)
- 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.
A key function of our brain is to identify temporal structures in the environment and use them to form expectations. These expectations allow us to plan and organize our behavior towards changes in the environment, and optimize the use of our attentional and motor resources. They also allow us to establish harmonious social interactions, coordinating us with our interlocutor during an exchange. Our ability to form temporal expectations seems to emerge very early but the development of this process is unknown. We only know that a set of basic skills, probably related to that ability, are present from birth. This suggests that temporal processing capabilities emerge during the prenatal period, but this has not been studied. The objective of this project is to study preterm infants brain's ability to process the intervals between stimuli and to form expectations on that basis.
Detailed description
40 patients (20 per group) : Presence of a functional response to stimulus omissions, only in the test group (regular presentation).
Group 1 will receive the test stimulation sequence (regular), Group 2 will receive the control stimulation sequence (random).
During the test sequence, a vibration will be repeated for 3 s interspersed with intervals of 5 s, creating an expectation about the presentation of the next stimulus. Every 8 to 12 vibrations (random), a vibration will be omitted. According to our hypothesis, we should observe an activity in the somatosensory cortex during the omission. A total of 10 omissions will be presented, bringing the total duration of stimulus presentation to 13 minutes.
During the control sequence, the interstimulus intervals are irregular, 3 to 7 seconds, so as not to induce expectations. Omissions in this case should not be associated with a functional brain response.
The presence of an activation in the primary somatosensory cortex will be assessed using Diffuse Correlation Spectroscopy (DCS), on newborns of 32, 33 and 35 weeks of corrected gestational age, during omissions in a regular vibrotactile stimulation sequence (test group) with respect to an irregular sequence (control group). A difference in activation during omissions between groups will reflect the presence of a processing of time intervals at the cortical level.
We will also assess the difference in amplitude and time to peak of the response between the corrected gestational ages and vigilance states.
Main endpoint: amplitude of the neurovascular response significantly higher and / or time to peak significantly shorter during the omissions in the test group (regular sequence) compared to the control group (irregular sequence), evaluated twice: at ages corrected SA 33 ± 3 days and 35 weeks ± 3 days , and if possible SA 32 ± 3 days (optional measure depending on the gestational age at birth and time to obtain consent).
Secondary endpoints: significant difference in amplitude and / or time to peak of the neurovasculat response between corrected gestational ages and vigilance states.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (Regular) | Experimental | Behavioral: Regular stimulation sequence, Device: DCSRegular stimulation sequence \& DCS |
| Control (Random) | Active comparator | Behavioral: Random stimulation sequence, Device: DCSRandom stimulation sequence \& DCS |
Who may qualify
- Ages
- Up to 6 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 40 premature infants born to SA 31 + 0 days to 32 weeks + 6 days , hospitalized in the neonatal unit of the University Hospital of Caen
Key exclusion criteria (7 listed)
- Suspected neurological disorder (grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia), or motor condition that might interfere with tactile perception on the hand
- Intubation or CPAP
- Viral of bacterial infection
- Sedation at the time of measurement
- Parent(s) who are minor or unable to give free and informed consent
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 |
|---|---|---|
| Regular stimulation sequenceVibrotactile stimulation of the right hand with regular intervals and random omissions | Behavioural | Test (Regular) |
| Random stimulation sequenceVibrotactile stimulation of the right hand with random intervals and random omissions | Behavioural | Control (Random) |
| DCSAlso: Diffuse correlation spectroscopyNear-infrared imaging of the neurovascular response in the left somatosensory cortex | Device | Control (Random), Test (Regular) |
Primary outcome
Activation of the primary somatosensory cortex during stimulation omissions
Time frame: Between 32 and 35 week of corrected gestational age
2 secondary outcomes
Change in amplitude or time to peak of the response as a function of age
Time frame: Between 32 and 35 week of corrected gestational age
Change in amplitude or time to peak of the response with age as a function of vigilance state
Time frame: Between 32 and 35 week of corrected gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Premature Birth
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
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.
Nadège RN Roche-Labarbe, PhD study chair
Université Caen Normandie
Questions about this trial
What is this clinical trial studying?
A study testing Regular stimulation sequence, Random stimulation sequence and DCS in people with Premature Birth, run by University Hospital, Caen.
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 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Bernard GB Guillois, MD (02.31.27.25.64 ext. +33, guillois-b@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activation of the primary somatosensory cortex during stimulation omissions (time frame: Between 32 and 35 week of corrected gestational age). 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 26 Aug 2016.