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Not Yet Recruiting NCT07702734

Dietary Pattern Intervention for Neurodevelopment in Preterm Infants

Conditions: Preterm, Neurodevelopmental Disorders, Dysbiosis

Sex: All
Ages: 6 Months – 6 Months
Healthy volunteers: No
Phase: NA
Enrollment: 116
Sponsor: Fudan University

Location: Shanghai Children's Hospital Shanghai Shanghai Municipality

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07702734). StuddyBuddy aggregates publicly available trial information.