NCT06336668

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 30 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

The fortification of human milk has been proven to enhance growth without raising the risk of necrotizing enterocolitis, although it may affect feeding tolerance. Non-invasive techniques like Doppler ultrasonography of the superior mesenteric artery (SMA) and near-infrared spectroscopy (NIRS) have been utilized to evaluate mesenteric blood flow and intestinal oxygenation in preterm infants. Numerous studies have investigated the relationship between SMA flow and feeding intolerance. Findings indicate a significant correlation between increased mean Superior Mesenteric Artery blood flow velocity and early tolerance of enteral feeding. Moreover, research suggests a higher incidence of necrotizing enterocolitis (NEC) in preterm infants exhibiting increased resistance patterns of SMA blood flow velocity on the first day. Non-invasive monitoring methods offer the ability to assess the impact of various fortification products on intestinal perfusion and oxygenation. This could aid in determining the most suitable fortification product to minimize episodes of feeding intolerance.

Conditions

• Feeding; Difficult, Newborn

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Human milk-based HMF	The study subject will be fed human milk fortified with a human-milk-based HMF.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2024-03-29
• Last updated: 2024-05-08