Assessment of Neurofilaments Levels in Premature Newborns: Study of Their Early Development

December 11, 2025 updated by: Laurent Servais, Centre Hospitalier Universitaire de Liege

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Late preterm infants (34-37 weeks of gestation) admitted to the neonatal unit

Description

Inclusion Criteria:

  • Gestational age between 34 and 37 weeks of amenorrhea.
  • Blood test scheduled for clinical reasons.
  • Signed parental consent.

Exclusion Criteria:

  • Known neurological disorders.
  • Severe congenital malformations.
  • Medical contraindication to blood sampling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Blood sampling for neurofilament analysis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From birth to 37 weeks of gestational age (up to 3 weeks after inclusion depending on gestational age at birth).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postnatal evolution of neurofilament concentrations
Time Frame: From birth up to 37 weeks of gestational age (longitudinal follow-up).
Analysis of changes in neurofilament levels over time in late preterm infants, from birth to 37 weeks of gestational age.
From birth up to 37 weeks of gestational age (longitudinal follow-up).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Liege

Collaborators

Centre Hospitalier Régional de la Citadelle

Investigators

  • Principal Investigator: Laurent Servais, MD, PhD, Centre Hospitalier Universitaire de Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 28, 2025

First Submitted That Met QC Criteria

September 5, 2025

First Posted (Estimated)

September 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neurofilaments

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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