Recruiting

Adjustable & Targeted

Sponsor:

University of Calgary

Code:

NCT04809350

Conditions

Growth Failure

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Adjustable Human Milk Fortification

Targeted Human Milk Fortification

Study Details

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

Study ID

NCT04809350

Start date

Nov 10, 2023

Status verified date

Nov, 2023

Completion date

May 31, 2025

Anticipated

Primary completion date

May 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Adjustable Human Milk Fortification

Human milk fortification based on blood urea levels

experimental: Targeted Human Milk Fortification

Human milk fortification based on milk analysis

Interventions

Adjustable Human Milk Fortification

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.

Targeted Human Milk Fortification

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.

Primary outcome measure

  • Average weight gain in infants on Adjustable versus Targeted human milk fortification [ Time Frame: Weekly for 8 weeks ]

Central Contacts and Locations

Central contacts

Belal N Alshaikh, MD, MSc

4039561588balshaik@ucalgary.ca

Adriana Reyes Loredo, MD

adriana.reyesloredo@albertahealthservices.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N2T9

Principal Investigator:

Belal Alshaikh, MD

More Information

Sponsor

University of Calgary

Last update posted

Nov 30, 2023

Last verified

Nov, 2023

Keywords

  • Human milk
  • Fortification
  • Preterm infants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2023-11-30.