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Dietary Pattern Intervention for Neurodevelopment in Preterm Infants

NCT07702734 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-07-14

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Structured High-Prebiotic Dietary Pattern

Individualized, face-to-face guidance and tailored recipes provided by a registered dietitian, focusing on the scientific introduction of prebiotic-rich complementary foods to promote endogenous beneficial gut bacteria over a 6-month period.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07702734 on ClinicalTrials.gov