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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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

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Feeding; Difficult, Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

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

Study Groups

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Bovine based-HMF

The infant will fed human milk fortified with bovine-based HMF.

Group Type ACTIVE_COMPARATOR

Human milk-based HMF

Intervention Type DIETARY_SUPPLEMENT

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

Human milk-based HMF

The infant will be fed human milk fortified with human milk-based HMF.

Group Type EXPERIMENTAL

Human milk-based HMF

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Human milk-based HMF

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.