Clinical trial Recruiting at 1 site Observational Ages Any age to 3 Weeks

Neurofilament levels in late preterm newborns during early life

Official title: Neurofilaments Levels in Premature Newborns

Run by Centre Hospitalier Universitaire de Liege · NCT07159555 · Data updated 2026-11-12

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.

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Quick facts

Study typeObservational
AgesAny age to 3 Weeks
SexAll
Enrollment15 (estimated)
SponsorCentre Hospitalier Universitaire de Liege
Academic / other
Locations1 site (Liège)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedAugust 31, 2026
Study endsDecember 31, 2026
Registry record updatedDecember 12, 2025
Trial IDNCT07159555 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Hopital Citadelle
    Liège, Belgium
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.