PediatricsPREMAVISIONNCT02908113
Visual Perception in Preterm Infants
A study testing collection data and IRM in people with Pediatrics, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
We aim to increase our knowledge of the impact of preterm birth on the maturation of the visual and auditory systems and on the development of multisensory perception Specifically, we aim to evaluate the preterm infants' capabilities of detection and discrimination of different visual and auditory stimuli according to… Read more about this study
- Who is it for?
- Ages 23 to 42 weeks
- Conditions the study is for
- Pediatrics
- What is being tested?
- collection data and IRM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Dec 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 23 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn less than 32 weeks PMA hospitalized in the Hospital of Hautepierre, Strasbourg, France)
- Consent obtained from both parents
- Social insurance coverage
Who cannot join
- Any known malformation
- Brain lesions discovered on brain ultrasound (Intra-Ventricular hemorrhage grade III or IV periventricular Leukomalacia).
- Unstable clinical State
- Retinopathy Of Prematurity stage> 2 or in zone 1
- Family history of abnormal color vision.
- Abnormalities in auditory testing
- Transfer to another hospital expected before 40 week PMA
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Les Hôiptaux Universitaires
Strasbourg, 67091
claire KOENIG ZORES, MD, 03.88.12.77.86, claire.KOENIG@chru-strasbourg.fr
Claire KOENIG ZORES, MD
About this study
Official title: Sensory Maturation of Preterm Infants: From Visual Sensitivity to Multisensory Perception
We aim to increase our knowledge of the impact of preterm birth on the maturation of the visual and auditory systems and on the development of multisensory perception
Specifically, we aim to evaluate the preterm infants' capabilities of detection and discrimination of different visual and auditory stimuli according to gestational age, post menstrual age and the duration of the postnatal life.
Read more
A secondary aim is to compare this competencies in preterm and full term control art term equivalent age.
The final aim is to optimize the hospital environment in order to make it correspond to the expectations and sensory abilities of very preterm infants.
Our hypothesis is that preterm birth exposes the infants to numerous atypical stimuli which could accelerate the processes of sensory maturation
- Conditions
- Pediatrics
- Being tested
- collection data, IRM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection dataBehavioural
IRMBehavioural
| Study group | Role | What they receive |
|---|---|---|
| preterm infants | Other | physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated Receives: Behavioral: collection data; Behavioral: IRM |
| term infants | Other | physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated Receives: Behavioral: collection data; Behavioral: IRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual stimulus detection with luminance
in "green" condition in hospital, luminance ( 100 and 300 lux ) and color (blue- red-yellow- white) variables
Measured: 3 months
auditory stimulus detection with parents voice
use parents voice, pure sound of 500 Hz
Measured: 3 months
Secondary outcomes (1)
behavioral responsiveness to visual stimuli calibrated collected from video recordings
Evaluate the facial expression of the imitation abilities in preterm and term neonates at term. The interpretation of the behavioral responses of newborns to mimic presented by the experimenter will be working independently by two observers with a coding grid
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies 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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire KOENIG ZORES, MD, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908113
- Sponsor's protocol ID
- 6123
- Acronym
- PREMAVISION
- Status last verified
- Oct 2016
- First submitted
- 26 Aug 2016
- Last updated
- 17 Oct 2017
- 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 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Maturation of Preterm Infants: From Visual Sensitivity to Multisensory Perception
- ClinicalTrials.gov ID
- NCT02908113
- Acronym / sponsor ID
- PREMAVISION / 6123
- Conditions
- Pediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Sep 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.
We aim to increase our knowledge of the impact of preterm birth on the maturation of the visual and auditory systems and on the development of multisensory perception
Specifically, we aim to evaluate the preterm infants' capabilities of detection and discrimination of different visual and auditory stimuli according to gestational age, post menstrual age and the duration of the postnatal life.
A secondary aim is to compare this competencies in preterm and full term control art term equivalent age.
The final aim is to optimize the hospital environment in order to make it correspond to the expectations and sensory abilities of very preterm infants.
Our hypothesis is that preterm birth exposes the infants to numerous atypical stimuli which could accelerate the processes of sensory maturation
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm infants | Other | Behavioral: collection data, Behavioral: IRMphysiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated |
| term infants | Other | Behavioral: collection data, Behavioral: IRMphysiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated |
Who may qualify
- Ages
- 23 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborn less than 32 weeks PMA hospitalized in the Hospital of Hautepierre, Strasbourg, France)
- Consent obtained from both parents
- Social insurance coverage
Key exclusion criteria (7 listed)
- Any known malformation
- Brain lesions discovered on brain ultrasound (Intra-Ventricular hemorrhage grade III or IV periventricular Leukomalacia).
- Unstable clinical State
- Retinopathy Of Prematurity stage> 2 or in zone 1
- Family history of abnormal color vision.
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 |
|---|---|---|
| collection data | Behavioural | preterm infants, term infants |
| IRM | Behavioural | preterm infants, term infants |
Primary outcome
visual stimulus detection with luminance
Time frame: 3 months
in "green" condition in hospital, luminance ( 100 and 300 lux ) and color (blue- red-yellow- white) variables
auditory stimulus detection with parents voice
Time frame: 3 months
use parents voice, pure sound of 500 Hz
1 secondary outcome
behavioral responsiveness to visual stimuli calibrated collected from video recordings
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- 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.
Claire KOENIG ZORES, MD principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collection data and IRM in people with Pediatrics, run by University Hospital, Strasbourg, France 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 3 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 17 Oct 2017. 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 Claire KOENIG ZORES, MD (03.88.12.77.86, claire.KOENIG@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual stimulus detection with luminance (time frame: 3 months). The study lists 2 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 17 Oct 2017.