Dietary Pattern Intervention for Neurodevelopment in Preterm Infants

NCT07702734 | Not Yet Recruiting DMC

• 1 other identifier: 2026R020- F02
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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

Preterm; Neurodevelopmental Disorders; Dysbiosis

Keywords

Dietary Pattern; Prebiotics; Gut-Brain Axis; Neonatal Antibiotic Exposure; Preterm Infants

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental Status Assessed by the Gesell Developmental Schedules (GDS)

  Neurodevelopmental trajectories will be quantitatively evaluated using the Gesell Developmental Schedules (GDS), which yield Developmental Quotients (DQs) across multiple domains (motor, adaptive, language, and personal-social). The DQ is a standardized score; a higher DQ score indicates better neurodevelopmental status and progression.

  Baseline and 6 months post-intervention

Secondary Outcomes (5)

• Parent-Reported Neurodevelopment Assessed by the Ages and Stages Questionnaires, Third Edition (ASQ-3)

  Baseline and 6 months post-intervention

• Change in Fecal Short-Chain Fatty Acid (SCFA) Concentrations Assessed by Gas Chromatography-Mass Spectrometry (GC-MS)

  Baseline, 3 months, and 6 months post-intervention

• Change in Fecal Tryptophan-Indole Derivatives Assessed by Liquid Chromatography-Mass Spectrometry (LC-MS)

  Baseline, 3 months, and 6 months post-intervention

• Change in Systemic Inflammatory Cytokine Levels Assessed by Enzyme-Linked Immunosorbent Assay (ELISA)

  Baseline, 3 months, and 6 months post-intervention

• Change in Gut Microbiota Alpha Diversity (Shannon Index) Assessed by 16S rRNA Sequencing

  Baseline and 6 months post-intervention

Study Arms (2)

Structured Dietary Pattern Group

EXPERIMENTAL

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.

Behavioral: Structured High-Prebiotic Dietary Pattern

Standard Care Group

NO INTERVENTION

Preterm infants in this group will receive routine neonatal follow-up and standard infant feeding practices for 6 months.

Interventions

Structured High-Prebiotic Dietary Pattern BEHAVIORAL

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.

Structured Dietary Pattern Group

Eligibility Criteria

• Age: 6 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with a gestational age between 28 and 37 weeks (inclusive of 28 weeks)
• Documented history of neonatal intravenous antibiotic exposure for at least 5 consecutive days during the neonatal period (e.g., in the NICU).
• Corrected age of 6 months ± 7days at the time of enrollment.
• No systemic antibiotic usage within 14 days prior to screening.
• Legal guardians are willing to sign the informed consent form and comply with the 6-month intervention and follow-up schedule.

You may not qualify if:

• Severe congenital malformations, chromosomal abnormalities, or inherited metabolic diseases (e.g., Down syndrome).
• Severe neurological disorders or structural brain injuries (e.g., Grade III/IV intraventricular hemorrhage, cystic periventricular leukomalacia, or hydrocephalus requiring a shunt).
• Severe chronic diseases affecting growth and development (e.g., congenital heart disease requiring surgery, short bowel syndrome, or severe sequelae of necrotizing enterocolitis).
• Concurrent participation in other interventional clinical trials.
• Planned long-term use of other commercial probiotic/prebiotic supplements outside the study protocol during the intervention period.
• High risk of loss to follow-up (e.g., expected relocation).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, 200062, China

Location

MeSH Terms

Conditions

Premature Birth; Neurodevelopmental Disorders; Dysbiosis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

WenXian Wang, Doctor

CONTACT

+86 13816964779; 24111020016@m.fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Public Health, Fudan University

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 14, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-06

Locations

CN (1)