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

NCT06336668 | Not Yet Recruiting DMC

• 1 other identifier: REB23-1283
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Feeding; Difficult, Newborn

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in SMA doppler peak flow velocity (PSV)

  6 hours

• Changes in SMA doppler end-diastolic velocity (EDV)

  6 hours

• Changes in SMA doppler Porcelout's resistance index (RI)

  6 hours

Study Arms (2)

Bovine based-HMF

ACTIVE COMPARATOR

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

Dietary Supplement: Human milk-based HMF

Human milk-based HMF

EXPERIMENTAL

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

Dietary Supplement: Human milk-based HMF

Interventions

Human milk-based HMF DIETARY_SUPPLEMENT

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

Bovine based-HMF; Human milk-based HMF

Eligibility Criteria

• Age: Up to 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born \<30 weeks' gestation age and less than 1500g of weight.
• Admitted in Neonatal Intensive Care Unit at Foothills Medical Center
• Reached full fortified enteral feed and at least 21 days of chronological age.

You may not qualify if:

• Chromosomal or major congenital anomalies
• Infants diagnosed with NEC.

Sponsors & Collaborators

• University of Calgary: lead

Study Officials

• Belal Alshaikh, MD, MSCE

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belal AlShaikh, MD, MSCE

CONTACT

(403) 956 1588; balshaik@ucalgary.ca

Basel Thayyil

CONTACT

Basel.Thayyil@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomizing the participants to either Bovine-HMF or Human Milk based-HMF will mask the Investigator
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 29, 2024
• Study Start: June 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share