Human Milk Fortification With Adjustable Versus Targeted Method

NCT04809350 | Unknown

• 1 other identifier: REB20-2139
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Research question: Do preterm infants born \<1250 g achieve better weight gain with targeted fortification compared with the adjustable fortification of human milk? Hypothesis: Targeted fortification of human milk results in better weight gain in infants with birth weight \<1250 gr when compared to the adjustable fortification. Study design: Open-label, pragmatic, parallel randomized controlled trial in appropriate for gestational age infants with birth weight \<1250 g.

Conditions

Growth Failure

Keywords

Human milk; Fortification; Preterm infants

Outcome Measures

Primary Outcomes (1)

• Average weight gain in infants on Adjustable versus Targeted human milk fortification

  Average weight gain measured as g/kg per day

  Weekly for 8 weeks

Secondary Outcomes (3)

• Anthropometrics in infants on Adjustable versus Targeted human milk fortification

  Weekly for 8 weeks

• BUN concentration in infants on Adjustable versus Targeted human milk fortification

  Weekly for 4 weeks

• Incidence of extra uterine growth restriction

  At 36 weeks CA

Study Arms (2)

Adjustable Human Milk Fortification

ACTIVE COMPARATOR

Human milk fortification based on blood urea levels

Dietary Supplement: Adjustable Human Milk Fortification

Targeted Human Milk Fortification

EXPERIMENTAL

Human milk fortification based on milk analysis

Dietary Supplement: Targeted Human Milk Fortification

Interventions

Adjustable Human Milk Fortification DIETARY_SUPPLEMENT

BUN and sodium concentrations will be measured every week in infants on full enteral feeds with fortified human milk. Liquid protein will be added based on serum urea.

Adjustable Human Milk Fortification

Targeted Human Milk Fortification DIETARY_SUPPLEMENT

Human milk will be analyzed twice weekly. Before the day of analysis, each mother will store fresh milk pumped from 10:00 AM until 8:00 AM of the previous day in a refrigerator and bring it to the hospital. Protein, fat, and sodium supplementation will be added to the human milk to meet the recommended daily intakes.

Targeted Human Milk Fortification

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants with birth weight \<1250 g born at Foothills Medical Centre.
• Appropriate for gestational age (AGA) (according to Fenton's Charts).

You may not qualify if:

• Abnormal Newborn Metabolic Screen
• Major congenital anomalies intervention.
• Patients who develop NEC prior to enrollment.
• Patients with confirmed congenital Toxoplasmosis, Syphilis, Rubella, Cytomegalovirus, Herpes simplex virus, Varicella and/or Zika (TORCH infections).
• Patients receiving systemic steroids.
• Patients with acute kidney injury (AKI).

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

RECRUITING

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Belal Alshaikh, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belal N Alshaikh, MD, MSc

CONTACT

4039561588; balshaik@ucalgary.ca

Adriana Reyes Loredo, MD

CONTACT

adriana.reyesloredo@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: November 10, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

CA (1)