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

Feeding; Difficult, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06336668
• Other study ID #: REB23-1283
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2024
• Source: University of Calgary
• Contact: Belal AlShaikh, MD, MSCE
• Phone: (403) 956 1588
• Email: balshaik[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Weeks

Eligibility

Inclusion Criteria:

1. Preterm infants born <30 weeks' gestation age and less than 1500g of weight.

2. Admitted in Neonatal Intensive Care Unit at Foothills Medical Center

3. Reached full fortified enteral feed and at least 21 days of chronological age.

Exclusion Criteria:

1. Chromosomal or major congenital anomalies

2. Infants diagnosed with NEC.

Related Conditions & MeSH terms

• Feeding; Difficult, Newborn
• Premature Birth

Intervention

Dietary Supplement:
• Human milk-based HMF
The study subject will be fed human milk fortified with a human-milk-based HMF.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy	Measurements of Near Infrared Spectroscopy are continuous but readings of interest are: before feeding, 30 and 120 minutes after finishing feed.	6 hours
Secondary	Changes in SMA doppler peak flow velocity (PSV)	SMA doppler will be performed before feed, and 30 and 120 minutes after completing the feed.	6 hours
Secondary	Changes in SMA doppler end-diastolic velocity (EDV)	SMA doppler will be performed before feed, and 30 and 120 minutes after completing the feed.	6 hours
Secondary	Changes in SMA doppler Porcelout's resistance index (RI)	SMA doppler will be performed before feed, and 30 and 120 minutes after completing the feed.	6 hours