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