Healthy ParticipantsNCT07159555
Assessment of Neurofilaments Levels in Premature Newborns: Study of Their Early Development
An observational study of Healthy Participants, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
This is a prospective observational study aiming to establish reference values of neurofilaments in late preterm newborns (34-37 weeks of gestation) and to evaluate their early postnatal evolution. Neurofilaments are neuronal proteins released into the blood when nerve cells are damaged. Read more about this study
- Who is it for?
- Ages Up to 3 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Blood sampling for neurofilament analysis
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2025to 31 Dec 2026
- 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 Up to 3 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Late preterm infants (34-37 weeks of gestation) admitted to the neonatal unit
Who may be able to join
- Gestational age between 34 and 37 weeks of amenorrhea.
- Blood test scheduled for clinical reasons.
- Signed parental consent.
Who cannot join
- Known neurological disorders.
- Severe congenital malformations.
- Medical contraindication to blood sampling.
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
Hopital Citadelle
Liège, 4000
Tamara Dangouloff, PhD, 0033662438138, tamara.dangouloff@uliege.be
Marie Machiels, marie.machiels@student.uliege.be
About this study
Official title: Neurofilaments Levels in Premature Newborns
This is a prospective observational study aiming to establish reference values of neurofilaments in late preterm newborns (34-37 weeks of gestation) and to evaluate their early postnatal evolution.
Neurofilaments are neuronal proteins released into the blood when nerve cells are damaged. They have emerged as promising biomarkers in neurodegenerative diseases, particularly in spinal muscular atrophy (SMA), where higher levels are associated with disease activity. However, very limited data exist on the normal dynamics of neurofilament levels in preterm infants.
Read more
In this study, up to 15 preterm newborns hospitalized in the neonatal unit will be enrolled (5 at 34 weeks, 5 at 35 weeks, 5 at 36 weeks of gestation). A maximum of 1 mL of additional blood will be collected only during routine clinically indicated blood draws, at birth, on day 2, and weekly until 37 weeks of gestation. Samples will be analyzed for neurofilament concentrations and compared across gestational ages, over time, and with existing data from term newborns and SMA patients.
The expected outcome is to generate normative data on neurofilament levels in late preterm infants, which will help interpret biomarker values in future studies and optimize early diagnosis and treatment strategies for neurodegenerative diseases such as SMA.
Read the detailed description
Recent therapeutic advances in spinal muscular atrophy (SMA) have highlighted the importance of very early treatment, ideally before the onset of symptoms. Neurofilaments, structural proteins of neurons released into the blood when axons are damaged, have been identified as sensitive biomarkers of neurodegeneration and disease activity in SMA. Elevated neurofilament levels have been reported in affected infants, with a rapid decline following initiation of effective treatment.
Despite their growing importance as a biomarker, little is known about the normal postnatal dynamics of neurofilaments in preterm infants. Establishing normative data in this population is essential to correctly interpret biomarker levels in newborn screening programs and clinical follow-up, particularly for conditions such as SMA where treatment decisions rely on early biological signals.
- Conditions
- Healthy Participants
- Being tested
- Blood sampling for neurofilament analysis
- Keywords
- Healthy Participants, Neurofilament, Premature infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for neurofilament analysisOther
An additional blood sample (maximum 1 mL) is collected during routine clinically indicated blood draws in late preterm infants (34-37 weeks of gestation). Samples are obtained at birth, day 2, and weekly until 37 weeks of gestation if blood draws are already planned. No separate venipuncture is performed. Samples are processed and stored for subsequent neurofilament concentration analysis.
| Study group | Role | What they receive |
|---|---|---|
| Neurofilament sampling in late preterm newborns | Late preterm infants (34-37 weeks of gestation) admitted to the neonatal unit. Up to 1 mL of additional blood will be collected during routine clinically indicated blood draws at birth, day 2, and weekly until 37 weeks of gestation. Samples will be analyzed for neurofilament concentrations. No independent venipuncture will be performed. Receives: Other: Blood sampling for neurofilament analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurofilament concentration in blood of late preterm infants
Measurement of blood neurofilament light chain (NfL) concentrations to establish reference values and describe their early postnatal evolution in late preterm infants.
Measured: From birth to 37 weeks of gestational age (up to 3 weeks after inclusion depending on gestational age at birth).
Secondary outcomes (1)
Postnatal evolution of neurofilament concentrations
Analysis of changes in neurofilament levels over time in late preterm infants, from birth to 37 weeks of gestational age.
Measured: From birth up to 37 weeks of gestational age (longitudinal follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Dec 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle
- Responsible party
- Principal investigator, Laurent Servais, Centre Hospitalier Universitaire de Liege
- Investigators
- Laurent Servais, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159555
- Sponsor's protocol ID
- Neurofilaments
- Status last verified
- Dec 2025
- First submitted
- 28 Aug 2025
- Last updated
- 12 Dec 2025
- 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofilaments Levels in Premature Newborns
- ClinicalTrials.gov ID
- NCT07159555
- Acronym / sponsor ID
- Neurofilaments
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, Neurofilament, Premature infant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Sep 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 is a prospective observational study aiming to establish reference values of neurofilaments in late preterm newborns (34-37 weeks of gestation) and to evaluate their early postnatal evolution.
Neurofilaments are neuronal proteins released into the blood when nerve cells are damaged. They have emerged as promising biomarkers in neurodegenerative diseases, particularly in spinal muscular atrophy (SMA), where higher levels are associated with disease activity. However, very limited data exist on the normal dynamics of neurofilament levels in preterm infants.
In this study, up to 15 preterm newborns hospitalized in the neonatal unit will be enrolled (5 at 34 weeks, 5 at 35 weeks, 5 at 36 weeks of gestation). A maximum of 1 mL of additional blood will be collected only during routine clinically indicated blood draws, at birth, on day 2, and weekly until 37 weeks of gestation. Samples will be analyzed for neurofilament concentrations and compared across gestational ages, over time, and with existing data from term newborns and SMA patients.
The expected outcome is to generate normative data on neurofilament levels in late preterm infants, which will help interpret biomarker values in future studies and optimize early diagnosis and treatment strategies for neurodegenerative diseases such as SMA.
Detailed description
Recent therapeutic advances in spinal muscular atrophy (SMA) have highlighted the importance of very early treatment, ideally before the onset of symptoms. Neurofilaments, structural proteins of neurons released into the blood when axons are damaged, have been identified as sensitive biomarkers of neurodegeneration and disease activity in SMA. Elevated neurofilament levels have been reported in affected infants, with a rapid decline following initiation of effective treatment.
Despite their growing importance as a biomarker, little is known about the normal postnatal dynamics of neurofilaments in preterm infants. Establishing normative data in this population is essential to correctly interpret biomarker levels in newborn screening programs and clinical follow-up, particularly for conditions such as SMA where treatment decisions rely on early biological signals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofilament sampling in late preterm newborns | – | Other: Blood sampling for neurofilament analysisLate preterm infants (34-37 weeks of gestation) admitted to the neonatal unit. Up to 1 mL of additional blood will be collected during routine clinically indicated blood draws at birth, day 2, and weekly until 37 weeks of gestation. Samples will be analyzed for neurofilament concentrations. No independent venipuncture will be performed. |
Who may qualify
- Ages
- Up to 3 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Late preterm infants (34-37 weeks of gestation) admitted to the neonatal unit
Key inclusion criteria (3 listed)
- Gestational age between 34 and 37 weeks of amenorrhea.
- Blood test scheduled for clinical reasons.
- Signed parental consent.
Key exclusion criteria (3 listed)
- Known neurological disorders.
- Severe congenital malformations.
- Medical contraindication to blood sampling.
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 |
|---|---|---|
| Blood sampling for neurofilament analysisAn additional blood sample (maximum 1 mL) is collected during routine clinically indicated blood draws in late preterm infants (34-37 weeks of gestation). Samples are obtained at birth, day 2, and weekly until 37 weeks of gestation if blood draws are already planned. No separate venipuncture is performed. Samples are processed and stored for subsequent neurofilament concentration analysis. | Other | Neurofilament sampling in late preterm newborns |
Primary outcome
Neurofilament concentration in blood of late preterm infants
Time frame: From birth to 37 weeks of gestational age (up to 3 weeks after inclusion depending on gestational age at birth).
Measurement of blood neurofilament light chain (NfL) concentrations to establish reference values and describe their early postnatal evolution in late preterm infants.
1 secondary outcome
Postnatal evolution of neurofilament concentrations
Time frame: From birth up to 37 weeks of gestational age (longitudinal follow-up).
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 12 Dec 2025.
- 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.
Laurent Servais, MD, PhD principal investigator
Centre Hospitalier Universitaire de Liege
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 Healthy Participants, run by Centre Hospitalier Universitaire de Liege 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 3 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 12 Dec 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 Tamara Dangouloff, PhD (+33662438138, tamara.dangouloff@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurofilament concentration in blood of late preterm infants (time frame: From birth to 37 weeks of gestational age (up to 3 weeks after inclusion depending on gestational age at birth).). 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 12 Dec 2025.