NCT03607942

Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants

Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 7 Days
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group will receive a neonatal supplement containing 2 specific HMOs. The control group will receive a placebo neonatal supplement that does not contain any HMOs, but matched to the experimental product in energy content. This study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age. The primary objective of the study is to demonstrate the safety and tolerance of HMOs in preterm infants by monitoring weight gain rates in both of the two randomized groups.

Conditions

• Premature Infant

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	HMO supplement	HMO supplement will be given three times a day, not mixed with any feeding.
DIETARY_SUPPLEMENT	Placebo comparator	Control product without any HMOs. The Placebo Comparator will be matched to the experimental product in energy content.

Timeline

• Start date: 2018-08-06
• Primary completion: 2020-10-30
• Completion: 2022-11-30
• First posted: 2018-07-31
• Last updated: 2023-03-21

Locations

7 sites across 1 country: France