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NOT YET RECRUITING
NCT06336668
NA

Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation

Sponsor: University of Calgary

View on ClinicalTrials.gov

Summary

Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives. The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks.

Key Details

Gender

All

Age Range

Any - 30 Weeks

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-06-01

Completion Date

2026-02-28

Last Updated

2024-05-08

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Human milk-based HMF

The study subject will be fed human milk fortified with a human-milk-based HMF.