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
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
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
NCT ID
NCT02716337
First Posted
March 7, 2016
Last Updated
March 17, 2016
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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
Learn more about this trial
Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
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