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

NCT07159555 | Recruiting

• 1 other identifier: Neurofilaments
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Participants

Keywords

Healthy Participants; Neurofilament; Premature infant

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From birth up to 37 weeks of gestational age (longitudinal follow-up).

Study Arms (1)

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

Interventions

Blood sampling for neurofilament analysis OTHER

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.

Neurofilament sampling in late preterm newborns

Eligibility Criteria

• Age: Up to 3 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead
• Centre Hospitalier Régional de la Citadelle: collaborator

Study Sites (1)

Hopital Citadelle

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laurent Servais, MD, PhD

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Dangouloff, PhD

CONTACT

+33662438138; tamara.dangouloff@uliege.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatrician

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)