Premature BirthNEOPRENENCT04703010
Neonatal Precursors of Neurodevelopment
A study testing Electroencephalography-Near infrared spectroscopy, Magnetic resonance imaging and Psychometric testing in people with Premature Birth, run by University Hospital, Caen at 1 site in France.
Trial summary
The NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive… Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Premature Birth
- What is being tested?
- Electroencephalography-Near infrared spectroscopy, Magnetic resonance imaging and Psychometric testing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 1 Sep 2024
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm newborn (born < 34 weeks + 6days)
Who cannot join
- Brain injury
- Respiratory assistance on measurement day
- Infection on measurement day
- Sedation on measurement day
- Parents < 18 years old or unable to give informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 13032
Nadege Roche-Labarbe, PhD, 33 232 568 386, nadege.roche@unicaen.fr
Victoria Dumont, PhD, victoria.dumont@unicaen.fr
About this study
The NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive precursors and neurodevelopment.
- Conditions
- Premature Birth
- Being tested
- Electroencephalography-Near infrared spectroscopy, Magnetic resonance imaging, Psychometric testing
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalography-Near infrared spectroscopyDevice
Brain activity will be measured using 128-channel EEG and 2 channel NIRS during tactile stimulation (15 minutes sequence of vibrations) while the newborn is asleep.
Magnetic resonance imagingDevice
Structural (T1-T2), siffusion tensor imaging and blood-oxygen level dependant signal will be acquired in a subset of 40 subjects (20 minutes while asleep)
Psychometric testingBehavioural
Cognitive evaluation at age 2 (Parental questionnaires on sensory profiles, executive functions and neurodevelopmental disorders screening, child tests : movement assessment battery, Laby, Head-toes-shoulders-knees)
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants undergo the same measurements (longitudinal design) Receives: Device: Electroencephalography-Near infrared spectroscopy; Device: Magnetic resonance imaging; Behavioral: Psychometric testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography evoked response amplitude
Electrical field potential changes in the parietal and frontal cortices
Measured: 35 weeks of gestational age
Near infrared spectroscopy evoked response amplitude
Oxygenated hemoglobin concentration changes in the somatosensory cortex
Measured: 35 weeks of gestational age
Grey matter volume in the somatosensory cortex
Thickness measured on T2 images in magnetic resonance imaging
Measured: 35 weeks GA
Frontal-parietal structural connectivity
Tractography using Diffusion tensor Imaging in magnetic resonance imaging
Measured: 35 weeks GA
Frontal-parietal functional connectivity
Synchronization at rest using blood-oxygen level dependent signal in magnetic resonance imaging
Measured: 35 weeks GA
Quality of cognitive development
Qualitative composite assessment using clinical interview, routine pediatric screening and questionnaires (full sensory profile, preschooler Behavior Rating Inventory of Executive Function)
Measured: 2 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Mar 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2024 (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 University Hospital, CaenThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal study with measures at birth and at age 2.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703010
- Sponsor's protocol ID
- 2020-A02117-32
- Acronym
- NEOPRENE
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2021
- Last updated
- 22 Mar 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 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Precursors of Neurodevelopment
- ClinicalTrials.gov ID
- NCT04703010
- Acronym / sponsor ID
- NEOPRENE / 2020-A02117-32
- Conditions
- Premature Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 11 Jan 2021 (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 NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive precursors and neurodevelopment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal study with measures at birth and at age 2.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: Electroencephalography-Near infrared spectroscopy, Device: Magnetic resonance imaging, Behavioral: Psychometric testingAll participants undergo the same measurements (longitudinal design) |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm newborn (born < 34 weeks + 6days)
Key exclusion criteria (5 listed)
- Brain injury
- Respiratory assistance on measurement day
- Infection on measurement day
- Sedation on measurement day
- Parents < 18 years old or unable to give 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 |
|---|---|---|
| Electroencephalography-Near infrared spectroscopyBrain activity will be measured using 128-channel EEG and 2 channel NIRS during tactile stimulation (15 minutes sequence of vibrations) while the newborn is asleep. | Device | All participants |
| Magnetic resonance imagingStructural (T1-T2), siffusion tensor imaging and blood-oxygen level dependant signal will be acquired in a subset of 40 subjects (20 minutes while asleep) | Device | All participants |
| Psychometric testingCognitive evaluation at age 2 (Parental questionnaires on sensory profiles, executive functions and neurodevelopmental disorders screening, child tests : movement assessment battery, Laby, Head-toes-shoulders-knees) | Behavioural | All participants |
Primary outcome
Electroencephalography evoked response amplitude
Time frame: 35 weeks of gestational age
Electrical field potential changes in the parietal and frontal cortices
Near infrared spectroscopy evoked response amplitude
Time frame: 35 weeks of gestational age
Oxygenated hemoglobin concentration changes in the somatosensory cortex
Grey matter volume in the somatosensory cortex
Time frame: 35 weeks GA
Thickness measured on T2 images in magnetic resonance imaging
Frontal-parietal structural connectivity
Time frame: 35 weeks GA
Tractography using Diffusion tensor Imaging in magnetic resonance imaging
Frontal-parietal functional connectivity
Time frame: 35 weeks GA
Synchronization at rest using blood-oxygen level dependent signal in magnetic resonance imaging
Quality of cognitive development
Time frame: 2 years old
Qualitative composite assessment using clinical interview, routine pediatric screening and questionnaires (full sensory profile, preschooler Behavior Rating Inventory of Executive Function)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- funding informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Premature Birth
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruitingObservational study
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Cardiac Abnormalities, Nutrient Intake
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalography-Near infrared spectroscopy, Magnetic resonance imaging and Psychometric testing in people with Premature Birth, run by University Hospital, Caen 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: status not confirmed, as of the sponsor's last update on 22 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography evoked response amplitude (time frame: 35 weeks of gestational age). The study lists 6 primary outcomes in all. 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 22 Mar 2022.