NCT07159555 Assessment of Neurofilaments Levels in Premature Newborns: Study of Their Early Development
| NCT ID | NCT07159555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Liege |
| Condition | Healthy Participants |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2025-12-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Laurent Servais, MD, PhD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Liege
Frequently Asked Questions
Who can join the NCT07159555 clinical trial?
This trial is open to participants of all sexes, up to 3 Weeks, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07159555 currently recruiting?
Yes, NCT07159555 is actively recruiting participants. Contact the research team at tamara.dangouloff@uliege.be for enrollment information.
Where is the NCT07159555 trial being conducted?
This trial is being conducted at Liège, Belgium.
Who is sponsoring the NCT07159555 clinical trial?
NCT07159555 is sponsored by Centre Hospitalier Universitaire de Liege. The principal investigator is Laurent Servais, MD, PhD at Centre Hospitalier Universitaire de Liege. The trial plans to enroll 15 participants.