Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants

Early Phase 1

Completed

• Conditions: Postnatal Growth Failure of Preterm Infants; Human Milk Fortification
• Interventions: Dietary Supplement: Addition of human milk fortifiers according to human milk analysis

• Registration Number: NCT02716337
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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 Timeline

• Study Start: 2014-10
• Primary Completion: 2015-03
• Status Verified: 2016-03
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-17
• Last Update Submitted: 2016-03-17
• Study First Posted: 2016-03-23
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Addition of human milk fortifiers according to human milk analysis	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

Primary Outcome Measures

Name	Time	Method
Daily growth velocity (g/kg/day)	From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)

Secondary Outcome Measures

Name	Time	Method
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 length 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)