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

Primary Purpose

Postnatal Growth Failure of Preterm Infants, Human Milk Fortification

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Addition of human milk fortifiers according to human milk analysis
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postnatal Growth Failure of Preterm Infants focused on measuring human milk target fortification

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Intervention group

    Arm 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

    Outcomes

    Primary Outcome Measures

    Daily growth velocity (g/kg/day)

    Secondary Outcome Measures

    weekly weight increase (g/week)
    weekly length increase (cm/week)
    head circumference increase (cm/week)

    Full Information

    First Posted
    March 7, 2016
    Last Updated
    March 17, 2016
    Sponsor
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02716337
    Brief Title
    Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postnatal Growth Failure of Preterm Infants, Human Milk Fortification
    Keywords
    human milk target fortification

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Other
    Arm 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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Addition of human milk fortifiers according to human milk analysis
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    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)
    Title
    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)
    Title
    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 Pre-specified Outcome Measures:
    Title
    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)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27370649
    Citation
    Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y.
    Results Reference
    derived

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

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