Clinical Trial

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

Recruiting
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Record status
This record was last updated December 8, 2025 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose \[2'FL\] and lacto-N-neotetraose \[LNnT\], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting. A comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-01-08; most recent amendment 2025-12-01.
Trial Details
NCT Number NCT06212427
Lead Sponsor Société des Produits Nestlé (SPN)
Conditions Premature Infant, Low Birthweight Infant
Enrollment 188 participants
Start Date 2023-11-20
Primary Completion 2026-02-28 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-12-08