Neurofilaments Levels in Premature Newborns

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 21 days
Healthy Volunteers: t
View:

• Gestational age between 34 and 37 weeks of amenorrhea.

• Blood test scheduled for clinical reasons.

• Signed parental consent.

Locations
Other Locations
Belgium
Hopital Citadelle
RECRUITING
Liège
Contact Information
Primary
Tamara Dangouloff, PhD
tamara.dangouloff@uliege.be
+33662438138
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 15
Treatments
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.
Sponsors
Leads: Centre Hospitalier Universitaire de Liege
Collaborators: Centre Hospitalier Régional de la Citadelle

This content was sourced from clinicaltrials.gov