Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06336668
Enrollment
18
Registered
2024-03-29
Start date
2024-06-01
Completion date
2026-02-28
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding; Difficult, Newborn

Keywords

Feed intolerance, Human Milk fortifier, Bovine based Human Milk Fortifier, Human milk based Human Milk Fortifier, Preterm infants

Brief 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.

Interventions

DIETARY_SUPPLEMENTHuman milk-based HMF

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

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Masking description

Randomizing the participants to either Bovine-HMF or Human Milk based-HMF will mask the Investigator

Intervention model description

Prospective randomized-controlled crossover trial comparing 2 different HMFs and 2 intestinal rSO2S periods in random order: 6 hours while on B-HMF and 6 hours on H-HMF with at least 6 hours washing period

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy6 hoursMeasurements of Near Infrared Spectroscopy are continuous but readings of interest are: before feeding, 30 and 120 minutes after finishing feed.

Secondary

MeasureTime frameDescription
Changes in SMA doppler peak flow velocity (PSV)6 hoursSMA doppler will be performed before feed, and 30 and 120 minutes after completing the feed.
Changes in SMA doppler end-diastolic velocity (EDV)6 hoursSMA doppler will be performed before feed, and 30 and 120 minutes after completing the feed.
Changes in SMA doppler Porcelout's resistance index (RI)6 hoursSMA doppler will be performed before feed, and 30 and 120 minutes after completing the feed.

Contacts

Primary ContactBelal AlShaikh, MD, MSCE
balshaik@ucalgary.ca(403) 956 1588
Backup ContactBasel Thayyil
Basel.Thayyil@albertahealthservices.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026