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

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Completed; Early Phase 1

Conditions: Human Milk Fortification; Postnatal Growth Failure of Preterm Infants

Treatments: Dietary Supplement: Addition of human milk fortifiers according to human milk analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02716337

Target HM fortification

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention group

Other group

Description:

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

Treatment:

Dietary Supplement: Addition of human milk fortifiers according to human milk analysis