Neurofilament levels in late preterm newborns during early life
Neurofilaments Levels in Premature Newborns
This project will test how neurofilament protein levels change in late preterm newborns (34–37 weeks) by measuring small blood samples at birth and weekly until 37 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | N/A to 3 Weeks |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Liege Academic / other |
| Locations | 1 site (Liège) |
| Trial ID | NCT07159555 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling up to 15 late preterm newborns to define normal neurofilament concentrations and their early postnatal trajectory. Participants (targeting cohorts at 34, 35, and 36 weeks) will have up to 1 mL of additional blood taken only during routine clinically indicated draws at birth, on day 2, and weekly until 37 weeks of gestation. Samples will be analyzed quantitatively for neurofilament levels and compared across gestational ages and over time. The work is motivated by neurofilaments' role as sensitive biomarkers in conditions such as spinal muscular atrophy and the current lack of normative data in preterm infants.
Who should consider this trial
Good fit: Late preterm newborns (gestational age 34–37 weeks) hospitalized in the neonatal unit who have a clinically indicated blood test and whose parents provide written consent.
Not a fit: Infants with known neurological disorders, severe congenital malformations, or those not undergoing clinically indicated blood draws are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, the study will generate reference values for neurofilament levels in late preterm infants that could improve interpretation of newborn biomarker results and help guide early treatment decisions for conditions like SMA.
How similar studies have performed: Neurofilament assays have shown clear signal in infants with SMA and in adult neurodegenerative diseases, but normative postnatal trajectories in preterm newborns remain largely uncharacterized.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Liège
- Hopital Citadelle — Liège, Belgium (Recruiting)
Study contacts
- Principal investigator: Laurent Servais, MD, PhD — Centre Hospitalier Universitaire de Liege
- Study coordinator: Tamara Dangouloff, PhD
- Email: tamara.dangouloff@uliege.be
- Phone: +33662438138
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.