Preterm and Term InfantsNCT07147673
fNIRS Grasping Task in Infants
An observational study of Preterm and Term Infants, run by University Ghent at 1 site in Belgium.
Trial summary
This study aims to investigate the neural mechanisms involved in the development of reach-to-grasp function in infants. Reaching and grasping are crucial motor skills that develop early in infancy and are essential for later motor and cognitive milestones. Read more about this study
- Who is it for?
- Ages 3 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterm and Term Infants
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Sep 2022to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants between 3 an 9 months old, living in Flanders (Belgium) born full term or preterm.
Who may be able to join
- 3-9 months old
- can tolerate the fNIRS cap
- performs at least 2 grapsing attempts with one hand within one minute when prompting the hand with a toy
Who cannot join
- history of periferal neurological lesion such as plexus brachialis lesion
- presence of epilepsia, congenital brain malformation,
- no informed consent
- severe visual impairments
- syndromal or genetical diseases resulting into developmental delay
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
hent University, vakgroep revalidatiewetenschappen
Ghent, Oost-Vlaanderen, 9000
Nele De Bruyn, Phd, 0032 9 332 69 21, nele.debruyn@ugent.be
Christine Van den Broeck, Prof, 0032 9 332 69 21, christine.vandenbroeck@ugent.be
About this study
Official title: Brain Function During Grasping Task in Three to Nine Months Infants Using fNIRS , the Difference Between Full and Preterm Born Infants
This study aims to investigate the neural mechanisms involved in the development of reach-to-grasp function in infants. Reaching and grasping are crucial motor skills that develop early in infancy and are essential for later motor and cognitive milestones. Understanding how these skills emerge and the underlying neural processes can provide valuable insights into both typical and atypical development.
The study will focus on infants aged 3 to 9 months, a critical period for the development of reach-to-grasp skills. A total of 100 infants will be recruited, including 50 full-term infants and 50 preterm infants (born <36 weeks gestational age). Reach-to-grasp function will be evaluated through a cross-sectional assessment at a single time point. Functional near-infrared spectroscopy (fNIRS) will be used as the brain imaging technique to measure brain activity during the reach-to-grasp task. The use of fNIRS will allow for a non-invasive assessment of neural activity in real time, providing insights into the brain mechanisms supporting the development of motor skills. The findings may offer important information about the neural basis of motor development in infancy, particularly in the context of preterm birth.
Read the detailed description
This study aims to investigate the neural mechanisms underlying the development of grasping function in infants aged 3 to 9 months. Specifically, it focuses on brain activity linked to reach-to-grasp movements, the role of maturation in this brain activity, the effect of preterm birth, and brain activity during bimanual toy exploration. The study will recruit 100 infants, including 50 full-term infants and 50 preterm infants (born at less than 36 weeks gestational age). Functional Near-Infrared Spectroscopy (fNIRS) will be used as the brain imaging technique to assess neural activity.
Objectives:
To investigate differences in brain activity during the reach-to-grasp task in 3-9-month-old infants between preterm and full-term infants.
To evaluate differences in the neural correlates of maturation of the reach-to-grasp motor skill.
To investigate differences in laterality index between preterm and full-term infants during bimanual toy exploration.
Method:
Fifty preterm and fifty full-term infants between 3 and 9 months corrected age will be assessed at a single time point. The assessment consists of an fNIRS event-related reach-to-grasp task protocol, where infants are encouraged to reach and grasp a toy, measured using the NSP2 system (NIRx). The task protocol includes 10 repetitions of each reach-to-grasp condition: 5 seconds of left-hand reach-to-grasp, 5 seconds of right-hand reach-to-grasp, and 10 seconds of bimanual toy exploration. A 10-second rest period is implemented between each reach-to-grasp action, and a 30-second rest period is implemented between conditions. Additionally, 5-7 minutes of resting-state fNIRS data will be recorded while infants watch a screensaver-like video to help maintain a resting state.
The fNIRS cap configuration consists of an 8×8 optode array covering the sensorimotor cortex. Cap size is adapted to the infant's head circumference (ranging between 42 and 46 cm), with the optode configuration remaining consistent across all cap sizes.
In addition to the fNIRS assessment, two clinical assessments will be conducted:
Hand Assessment for Infants (HAI): Evaluates hand function in infants. Hammersmith Infant Neurological Examination (HINE): Assesses neurological development.
- Conditions
- Preterm and Term Infants
- Keywords
- fNIRS, grasping, infants, preterm infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| full term infants | infants between 3-9 months old with gestational age more than 36 weeks | |
| preterm infants | infants between 3-9 months old corrected age born with a gestational age less than 36 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
fNIRS laterality index
Difference in brain activitity over the sensorimotor cortex between left and right hemisphere during bilateral grasping. Averaged brain activity of the 10 blocks of bimanual grasping.
Measured: Baseline
Secondary outcomes (6)
fNIRS bimanual activity
Averaged brain activity during the 10 blocks of bimanual reach-to-grasp movements.
Measured: baseline
fNIRS unmanual left-sided activity
Averaged brain activity during the 10 blocks of unilateral left-sided reach-to-grasp movements.
Measured: baseline
Hand assessment for Infants (HAI)
An assessment of hand function. It has been developed for infants at risk of developing cerebral palsy (CP) in the age range of 3-12 months. The HAI intends to measure the degree and quality of goal directed actions performed with each hand separately as well as with both hands together.
Items are scored based on a video-taped play session eliciting upper limb activity.
It results in three scales
- both hand measure: a criterian referenced overall measure of hand function based on all 17 items total raw score ranges ; 0-58 HAI-unit scale: 0-100 Higher score indicates better ability
- each hand sum score: a unimanual criterion referenced subscale based on 12 out of 17 items, score rated for each hand seperatly raw score ranges: 0-24 higher score indicates better ability
- percentage of difference between hands : percent calculated by the differences in left and right each hand sum score higer value indicate bigger difference between hands age norm references available
Measured: baseline
Hammersmith infant neurological examination (HINE)
Hammersmith infant neurological examniation is a standardized neurological exam for infants adjusted age 2 to 24 months. The HINE evaluates nerve function, movements, reflexes and reactions, posture, and tone and can help clinicians identify movement disorders including cerebral palsy (CP).
26 items scoring 0-3 total score : 0-78 Higher score indicates more optimal developement normative data for age-matched, typically developing infants helps determine if the score is optimal or suboptimal.
Measured: baseline
fNIRS resting state functional connectivity
Functional connectivity within the sensorimotor cortex during a 5-7minutes of rest.
Measured: baseline
fNIRS unmanual right-sided activity
Averaged brain activity during the 10 blocks of unilateral right-sided reach-to-grasp movements.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start26 Sep 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm and Term InfantsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nele De Bruyn, Phd, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147673
- Sponsor's protocol ID
- ONZ-2022-0265
- Status last verified
- Aug 2025
- First submitted
- 14 Apr 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It concerns personal data. There must first be investigated to which extent this data can be pseunominized for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Function During Grasping Task in Three to Nine Months Infants Using fNIRS , the Difference Between Full and Preterm Born Infants
- ClinicalTrials.gov ID
- NCT07147673
- Acronym / sponsor ID
- ONZ-2022-0265
- Conditions
- Preterm and Term Infants
- Keywords
- fNIRS, grasping, infants, preterm infants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 29 Aug 2025 (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.
This study aims to investigate the neural mechanisms involved in the development of reach-to-grasp function in infants. Reaching and grasping are crucial motor skills that develop early in infancy and are essential for later motor and cognitive milestones. Understanding how these skills emerge and the underlying neural processes can provide valuable insights into both typical and atypical development.
The study will focus on infants aged 3 to 9 months, a critical period for the development of reach-to-grasp skills. A total of 100 infants will be recruited, including 50 full-term infants and 50 preterm infants (born <36 weeks gestational age). Reach-to-grasp function will be evaluated through a cross-sectional assessment at a single time point. Functional near-infrared spectroscopy (fNIRS) will be used as the brain imaging technique to measure brain activity during the reach-to-grasp task. The use of fNIRS will allow for a non-invasive assessment of neural activity in real time, providing insights into the brain mechanisms supporting the development of motor skills. The findings may offer important information about the neural basis of motor development in infancy, particularly in the context of preterm birth.
Detailed description
This study aims to investigate the neural mechanisms underlying the development of grasping function in infants aged 3 to 9 months. Specifically, it focuses on brain activity linked to reach-to-grasp movements, the role of maturation in this brain activity, the effect of preterm birth, and brain activity during bimanual toy exploration. The study will recruit 100 infants, including 50 full-term infants and 50 preterm infants (born at less than 36 weeks gestational age). Functional Near-Infrared Spectroscopy (fNIRS) will be used as the brain imaging technique to assess neural activity.
Objectives:
To investigate differences in brain activity during the reach-to-grasp task in 3-9-month-old infants between preterm and full-term infants.
To evaluate differences in the neural correlates of maturation of the reach-to-grasp motor skill.
To investigate differences in laterality index between preterm and full-term infants during bimanual toy exploration.
Method:
Fifty preterm and fifty full-term infants between 3 and 9 months corrected age will be assessed at a single time point. The assessment consists of an fNIRS event-related reach-to-grasp task protocol, where infants are encouraged to reach and grasp a toy, measured using the NSP2 system (NIRx). The task protocol includes 10 repetitions of each reach-to-grasp condition: 5 seconds of left-hand reach-to-grasp, 5 seconds of right-hand reach-to-grasp, and 10 seconds of bimanual toy exploration. A 10-second rest period is implemented between each reach-to-grasp action, and a 30-second rest period is implemented between conditions. Additionally, 5-7 minutes of resting-state fNIRS data will be recorded while infants watch a screensaver-like video to help maintain a resting state.
The fNIRS cap configuration consists of an 8×8 optode array covering the sensorimotor cortex. Cap size is adapted to the infant's head circumference (ranging between 42 and 46 cm), with the optode configuration remaining consistent across all cap sizes.
In addition to the fNIRS assessment, two clinical assessments will be conducted:
Hand Assessment for Infants (HAI): Evaluates hand function in infants. Hammersmith Infant Neurological Examination (HINE): Assesses neurological development.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| full term infants | – | –infants between 3-9 months old with gestational age more than 36 weeks |
| preterm infants | – | –infants between 3-9 months old corrected age born with a gestational age less than 36 weeks |
Who may qualify
- Ages
- 3 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants between 3 an 9 months old, living in Flanders (Belgium) born full term or preterm.
Key inclusion criteria (3 listed)
- 3-9 months old
- can tolerate the fNIRS cap
- performs at least 2 grapsing attempts with one hand within one minute when prompting the hand with a toy
Key exclusion criteria (5 listed)
- history of periferal neurological lesion such as plexus brachialis lesion
- presence of epilepsia, congenital brain malformation,
- no informed consent
- severe visual impairments
- syndromal or genetical diseases resulting into developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fNIRS laterality index
Time frame: Baseline
Difference in brain activitity over the sensorimotor cortex between left and right hemisphere during bilateral grasping. Averaged brain activity of the 10 blocks of bimanual grasping.
6 secondary outcomes
fNIRS bimanual activity
Time frame: baseline
fNIRS unmanual left-sided activity
Time frame: baseline
Hand assessment for Infants (HAI)
Time frame: baseline
Hammersmith infant neurological examination (HINE)
Time frame: baseline
fNIRS resting state functional connectivity
Time frame: baseline
fNIRS unmanual right-sided activity
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Undecided. It concerns personal data. There must first be investigated to which extent this data can be pseunominized for sharing.
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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.
Nele De Bruyn, Phd principal investigator
University Ghent
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 Preterm and Term Infants, run by University Ghent at 1 site in Belgium.
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 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nele De Bruyn, Phd (00329 332 69 21, nele.debruyn@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fNIRS laterality index (time frame: Baseline). 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 29 Aug 2025.