Human Milk-derived Fortification in Preterm Infants

Effect of Human Milk-derived Fortifiers on Weight Gain in Preterm Infants <1250 g: A Randomized Controlled Trial

Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW) infants. Multi-nutrient human milk fortifiers (HMFs) are designed to meet the macro and micro-nutrient needs of VLBW infants. HMFs differ by the origin of milk and by nutrient composition. Traditionally, bovine milk has been the main source of multi-nutrient HMFs.

Study Overview

• Status: Not yet recruiting
• Conditions: Necrotizing Enterocolitis; Postnatal Growth Restriction
• Intervention / Treatment: Dietary supplement: Human milk-derived HMF; Dietary supplement: bovine milk-derived HMF

Detailed Description

Recent advances in lacto-engineering techniques allowed the manufacturing of multi-nutrient HMF from human milk as an alternative to bovine milk. Since exposure to infant bovine-based formula feeds is frequently shown to increase neonatal morbidities, human milk-derived HMFs (H-HMFs) have been frequently proposed to minimize exposure to bovine products prior to 34 weeks gestation with an intent to decrease the risks of necrotizing enterocolitis and feeding intolerance. The use of multi-nutrient H-HMFs is a promising intervention however currently available H-HMFs are expensive.

The main objective of this randomized controlled trial is to compare the weight gain achieved by preterm infants born <1250 g and fed human milk fortified with H-HMFs (made from mother's own milk (MOM) when MOM supply exceeds the daily need of her preterm infant or from donor human milk (DHM) compared with counterparts fed human milk fortified with the currently used bovine-derived fortifier (B-HMF).

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Belal Alshaikh, MD, MSc; Phone Number: 4039561588; Email: balshaik@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Foothills Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Birthweight between 400 g-1250 g
• Less than or 32 weeks gestational age at birth
• Subject has been classified as appropriate for gestational age
• Enteral feeding of human milk is initiated by 72 hours
• Subject is expected to be on human milk for at least 3 weeks.

Exclusion Criteria:

• Congenital abnormalities or underlying disease that may affect growth
• Maternal cocaine, alcohol, or opioid abuse during pregnancy
• Mother or infant is currently receiving treatment for HIV infection
• Infant with major surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Human milk-derived HMF; Fortification with human milk-derived product	Dietary supplement: Human milk-derived HMF; Fortification with human milk-derived product
Other: Bovine milk-derived HMF; Current standard practice: Fortification with bovine milk-derived product	Dietary supplement: bovine milk-derived HMF; bovine milk-derived HMF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average weight gain	Average weight gain measured as g/kg per day	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Head circumference	Measurement of head circumference in centimeters	Weekly for 8 weeks
Length	Measurement of length in centimeters	Weekly for 8 weeks
Feed intolerance	Incidence of interruption in enteral feeding due to feed intolerance (vomiting or abdominal distension), unrelated to a clinical procedure, that lasted for ≥12 hours or a >50% reduction in volume over the same time frame.	3 weeks
Electrolytes abnormalities	Incidence of any abnormality in one of the following electrolytes: sodium, potassium, calcium and phosphorus	3 weeks
Need for additional signal nutrient supplementation	Number of additions of single nutrient supplementation (include protein, fat and carbohydrate) in each group.	3 weeks

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Belal Alshaikh, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2023
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): May 30, 2025

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Human milk
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: REB22-039

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No