Clinical trial NCT06336668: Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation
Official title: Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Feeding; Difficult, Newborn
Keywords: Feed intolerance
Human Milk fortifier
Bovine based Human Milk Fortifier
Human milk based Human Milk Fortifier
Preterm infants
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 18
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy
timeFrame: 6 hours
Secondary outcomes:
measure: Changes in SMA doppler peak flow velocity (PSV)
timeFrame: 6 hours
measure: Changes in SMA doppler end-diastolic velocity (EDV)
timeFrame: 6 hours
measure: Changes in SMA doppler Porcelout's resistance index (RI)
timeFrame: 6 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Belal Alshaikh, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: