Dietary Pattern Intervention for Neurodevelopment in Preterm Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-6
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Structured High-Prebiotic Dietary Pattern
BehavioralIndividualized, 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.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Structured Dietary Pattern GroupExperimental treatment 1 intervention
Group B: Standard Care GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline and 6 months post-interventionSecondary outcomes
1
Parent-Reported Neurodevelopment Assessed by the Ages and Stages Questionnaires, Third Edition (ASQ-3)
Neurodevelopment will be secondarily assessed using the Ages and Stages Questionnaires, Third Edition (ASQ-3), a parent-completed screening tool. It evaluates communication, gross motor, fine motor, problem-solving, and personal-social skills. Higher scores indicate better developmental milestones achievement.
Time frame
Baseline and 6 months post-intervention2
Change in Fecal Short-Chain Fatty Acid (SCFA) Concentrations Assessed by Gas Chromatography-Mass Spectrometry (GC-MS)
Targeted metabolomic profiling will be conducted to quantify fecal SCFA concentrations (primarily acetate, propionate, and butyrate) using Gas Chromatography-Mass Spectrometry (GC-MS). A quantitative assessment of these microbial metabolites provides insight into gut fermentation capacity. Data will be reported in micromoles per gram (μmol/g) of wet feces.
Time frame
Baseline, 3 months, and 6 months post-intervention3
Change in Fecal Tryptophan-Indole Derivatives Assessed by Liquid Chromatography-Mass Spectrometry (LC-MS)
Targeted metabolomic analysis using Liquid Chromatography-Mass Spectrometry (LC-MS) will be utilized to quantify the concentrations of specific fecal tryptophan-indole derivatives, which are crucial gut-brain axis signaling molecules. Data will be reported in nanograms per gram (ng/g) or micrograms per gram (μg/g) of feces.
Time frame
Baseline, 3 months, and 6 months post-intervention4
Change in Systemic Inflammatory Cytokine Levels Assessed by Enzyme-Linked Immunosorbent Assay (ELISA)
Systemic signaling pathways will be evaluated by quantifying the serum concentrations of key inflammatory cytokines (e.g., IL-6, TNF-alpha) using Enzyme-Linked Immunosorbent Assay (ELISA) kits. Data will be reported in picograms per milliliter (pg/mL).
Time frame
Baseline, 3 months, and 6 months post-interventionSponsors and contacts
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Source ClinicalTrials.gov
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