Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Postnatal Growth Failure of Preterm Infants
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Enrollment
- 10
- Primary Endpoint
- Daily growth velocity (g/kg/day)
- Status
- Completed
- Last Updated
- 10 years ago
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.
Investigators
Prof. Pier Mannuccio Mannucci
PHD
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
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))