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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02716337

Enrollment

Registered

2016-03-23

Start date

2014-10-31

Completion date

Unknown

Last updated

2016-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Milk Fortification, Postnatal Growth Failure of Preterm Infants

Keywords

human milk target fortification

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.

Interventions

DIETARY_SUPPLEMENTAddition of human milk fortifiers according to human milk analysis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

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)

Design outcomes

Primary

Measure	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

Measure	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)

Other

Measure	Time frame
osmolality of fortified human milk	From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026