Effect of Adjustable Versus Targeted Human Milk Fortification on Weight Gain in Preterm Infants With Birth Weight <1250 g: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Calgary
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Average weight gain in infants on Adjustable versus Targeted human milk fortification
Study Overview
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.
Detailed Description
Human milk is the ideal diet for neonates. However, it does not provide enough energy, protein, and sodium to meet the nutritional requirements of very preterm infants. Postnatal growth failure is common despite the current use of human milk fortifiers. The main human milk fortification methods include:
-
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
-
Individualized human milk fortification which encompasses two methods:
-
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.
-
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Average weight gain in infants on Adjustable versus Targeted human milk fortification
Time Frame: Weekly for 8 weeks
Average weight gain measured as g/kg per day
Secondary Outcomes
- BUN concentration in infants on Adjustable versus Targeted human milk fortification(Weekly for 4 weeks)
- Anthropometrics in infants on Adjustable versus Targeted human milk fortification(Weekly for 8 weeks)
- Incidence of extra uterine growth restriction(At 36 weeks CA)