Individualized Human Milk Fortification for Very Low Birth Weight Infants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve the growth and brain development of very low birth weight infants through enhanced nutrition. It will compare three methods of fortifying human milk: standard fortification, target fortification, and BUN adjustable fortification (Blood Urea Nitrogen adjustable fortification) to determine which best supports these infants' needs. Infants weighing 1250 grams or less at birth, or born before 30 weeks and weighing less than 1500 grams, may qualify, particularly if they have not yet received other fortifiers or formulas. The trial will monitor the infants' growth and development during their hospital stay and up to 24 months. This research seeks to identify the most effective way to support the health and development of these tiny newborns. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking knowledge that could enhance the care of vulnerable infants.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What prior data suggests that these fortification methods are safe for very low birth weight infants?
Research shows that both BUN adjustable and target fortification methods for human milk are safe for very low birth weight infants.
For BUN adjustable fortification, studies have found that using blood urea nitrogen (BUN) levels to guide protein addition is safe. This method helps preterm infants grow better by ensuring they receive the right nutrients. These studies have reported no major safety issues.
Target fortification is also considered safe. Research indicates that adding specific nutrients to human milk based on a baby's needs can improve growth and nutrition without causing harm.
Both methods aim to provide better nutrition than standard fortification, and current studies support their safety for infants who need extra nutrients to grow.12345Why are researchers excited about this trial?
Researchers are excited about the trial for individualized human milk fortification for very low birth weight infants because it explores innovative ways to enhance infant nutrition. Unlike standard fortification, which uses a one-size-fits-all approach, the BUN adjustable fortification tailors the nutrient content based on the infant's blood urea nitrogen levels, potentially optimizing growth and health outcomes. Meanwhile, target fortification aims for precise nutritional targets, offering a more personalized nutritional strategy. These methods could lead to more effective and customized nutritional care for vulnerable infants, potentially improving their development and reducing complications.
What evidence suggests that this trial's fortification methods could be effective for very low birth weight infants?
This trial will compare different methods of human milk fortification for very low birth weight infants. Research has shown that BUN adjustable fortification, one method under study, uses blood urea nitrogen levels to tailor the protein content in breast milk, ensuring each baby receives the right amount of protein. This method is safe and effective for improving growth in these infants. Another method in this trial, target fortification, directly matches the nutrient needs of infants, resulting in higher protein intake and better growth. Studies have found that infants receiving targeted fortification demonstrate improved body composition and growth compared to standard methods. Both BUN adjustable and target fortification methods show promise for enhancing nutrition and growth in very low birth weight infants.12567
Who Is on the Research Team?
Sharon Unger, MD
Principal Investigator
Sinai Health System
Deborah O'Connor, PhD RD
Principal Investigator
The Hospital for Sick Children
Are You a Good Fit for This Trial?
This trial is for infants born weighing ≤ 1250 g. They must have parental consent and can use donor milk if needed. Infants who might transfer to a non-participating NICU, received fortifiers or formula before the study, are over 21 days old at start, in another nutrition study, or have growth-affecting anomalies cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive feeds fortified according to standard, target, or BUN adjustable methods until 36 weeks gestational age or hospital discharge
Follow-up
Growth and body composition are assessed at 4 months corrected age, and neurodevelopment is assessed at 18-24 months corrected age
What Are the Treatments Tested in This Trial?
Interventions
- BUN adjustable fortification
- Standard fortification
- Target fortification
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Hospital for Sick Children
Lead Sponsor