Human Milk Fortification With Adjustable Versus Targeted Method
NCT ID: NCT04809350
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
52 participants
INTERVENTIONAL
2023-11-10
2025-05-31
Brief Summary
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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.
Detailed Description
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1. standard HM fortification (SF) which assumes an average composition of breast milk and adds fortifiers in a fixed dosage. It does not account for variations of nutrient content in human milk
2. Individualized human milk fortification which encompasses two methods:
1. Adjustable HM fortification (AF): Protein supplementation is provided in addition to SF according to blood urea nitrogen (BUN) concentration which reflects the infant's metabolic response to protein intake. However, there are clinical scenarios in which the BUN levels are not a reliable marker of protein intake, such as acute kidney injury.
2. Targeted HM fortification (TF): Based on routine analyses of HM that are used to adjust fortification to meet the recommended requirements for infants. It does not take into consideration that the requirements of infants may vary.
SF has frequently failed to achieve appropriate weight gain, while individualized (AF or TF) fortification seems to have better performance. However, the evidence to support one method over the other is lacking.
The objective of the study is to compare weekly average weight gain between preterm infants on AF versus TF.
Once the written consent is obtained, the infant will be randomized to AF or TF. The sequence code will be kept in sequential numbered sealed envelopes. Infants from multiple births will be included as 1 unit and randomized to the same arm of the study.
For patients allocated to the TF group, breast milk will be analyzed twice weekly for energy, protein, and sodium contents. The daily protein, fat, and sodium intakes will be then calculated and optimized to meet the recommended dietary reference intake (DRI) for preterm infants with birth weight \<1250 g.
For patients allocated to the AF group, weekly BUN measurements will be performed. Based on BUN concentrations, the liquid protein will be added to achieve the targeted BUN level. Additional calories will be added using formula if growth is suboptimal or DRI is not met based on the assumed human milk content for protein and energy.
The intervention will last 4-8 weeks. For all patients, the day the first BUN concentration and milk analyses are done will be day 1 of intervention. The following measurements will be performed on days 7-8, 14-16, 21-23, and 28-30 of intervention: Weight (grams), length and head circumference (centimeters), BUN and sodium concentrations.
Data on maternal and neonatal characteristics will be collected from their electronic and physical charts.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Adjustable Human Milk Fortification
Human milk fortification based on blood urea levels
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 fortification based on milk analysis
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Appropriate for gestational age (AGA) (according to Fenton's Charts).
Exclusion Criteria
* 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).
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Belal Alshaikh, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Belal Alshaikh, MD
Role: primary
Other Identifiers
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REB20-2139
Identifier Type: -
Identifier Source: org_study_id