Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Primary Endpoint
- Daily growth velocity (g/kg/day)
Study Overview
Brief Summary
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Standard fortification is the most commonly used supplementation practice but it does not consider the native variability of human milk. Data on efficacy and safety of prolonged target fortification are scarce. The investigators performed a prospective interventional study in VLBW preterm infants, exclusively fed with human milk, to test efficacy and metabolic safety of target fortification in these preterm infants.
Detailed Description
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Fortified human milk is the goal for preterm infants' nutrition. Standard fortification is the most commonly used and safe supplementation practice but it does not consider the native variability of human milk. Data on efficacy and safety of prolonged target fortification are scarce. Prospective interventional study was conducted in VLBW preterm infants, exclusively fed with human milk. Twenty-four hour collected pools of human milk were analyzed and targeted human milk fortification was performed during hospitalization. Weekly growth and daily growth velocity were compared with that of an historical group of VLBW preterm infants that had received standard fortified human milk. Osmolality, metabolic and gastrointestinal tolerance were monitored.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Birth weight < 1500 grams
- •Gestational age < 32 weeks
- •Birth weight > 10th percentile according to Fenton' growth chart
- •Exclusively breast feeding during the entire hospital stay
Exclusion Criteria
- •Presence of congenital malformations that could affect growth (congenital diseases, chromosomal abnormalities, chronic lung disease, severe brain disease, severe metabolic, cardiac or gastrointestinal diseases)
Arms & Interventions
Intervention group
In the intervention group VLBW infants were fed target fortified human milk Growth and safety were compared to a historical group of VLBW infants fed with standard fortified human milk
Intervention: Addition of human milk fortifiers according to human milk analysis (Dietary Supplement)
Outcomes
Primary Outcomes
Daily growth velocity (g/kg/day)
Time Frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
Secondary Outcomes
- weekly length increase (cm/week)(From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks))
- head circumference increase (cm/week)(From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks))
- weekly weight increase (g/week)(From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks))
Investigators
Prof. Pier Mannuccio Mannucci
PHD
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico