Human Milk-derived Fortification in Preterm Infants

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05228847
• Other study ID #: REB22-039
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: November 2022
• Source: University of Calgary
• Contact: Belal Alshaikh, MD, MSc
• Phone: 4039561588
• Email: balshaik[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: May 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Days to 12 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Dietary Supplement:
• Human milk-derived HMF
Fortification with human milk-derived product
• bovine milk-derived HMF
bovine milk-derived HMF

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average weight gain	Average weight gain measured as g/kg per day	up to 3 weeks
Secondary	Head circumference	Measurement of head circumference in centimeters	Weekly for 8 weeks
Secondary	Length	Measurement of length in centimeters	Weekly for 8 weeks
Secondary	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
Secondary	Electrolytes abnormalities	Incidence of any abnormality in one of the following electrolytes: sodium, potassium, calcium and phosphorus	3 weeks
Secondary	Need for additional signal nutrient supplementation	Number of additions of single nutrient supplementation (include protein, fat and carbohydrate) in each group.	3 weeks