Clinical Trial

Dietary Pattern Intervention for Neurodevelopment in Preterm Infants

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
The purpose of this randomized controlled trial is to evaluate the effect of a structured, high-prebiotic dietary pattern on the neurodevelopmental outcomes of preterm infants. The intervention lasts for 6 months and aims to promote the growth of endogenous beneficial gut bacteria through targeted complementary feeding. The primary outcome is assessed by the Gesell Developmental Schedules or the Ages \& Stages Questionnaires (ASQ-3). Secondary outcomes include longitudinal changes in gut microbiota composition,targeted metabolomics (such as short-chain fatty acids and tryptophan metabolites), and systemic inflammatory markers.
Trial Details
NCT Number NCT07702734
Lead Sponsor Fudan University
Conditions Preterm, Neurodevelopmental Disorders, Dysbiosis
Enrollment 116 participants
Start Date 2026-07-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-14