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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Postnatal Growth Failure of Preterm Infants, Human Milk Fortification

Intervention / Treatment
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* Dietary Supplement: Addition of human milk fortifiers according to human milk analysis


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention group<br>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 | Dietary Supplement: Addition of human milk fortifiers according to human milk analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weekly weight increase (g/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) | 
| head circumference increase (cm/week) |  | From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human milk target fortification