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Completed

NCT Number: NCT02716337

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

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.

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Key information

Conditions

Postnatal Growth Failure of Preterm Infants Human Milk Fortification

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Addition of human milk fortifiers according to human milk analysis

Dietary Supplement

Primary outcomes

  1. 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

  1. weekly weight increase (g/week)

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

  2. weekly length increase (cm/week)

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

  3. head circumference increase (cm/week)

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

Other outcomes

  1. osmolality of fortified human milk

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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
First posted
Mar 23, 2016
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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