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Individualized Maternal Milk Fortification for Feeding the Preterm Infants

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Tailored protein fortification
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring preterm neonate, tailored fortification, nutrition, maternal breast milk composition

Eligibility Criteria

24 Hours - 5 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Infants with gestational age ≤ 34weeks
  • very low birth weight (≤ 1500g)

Exclusion Criteria:

  • maternal health problems contradicting breastfeeding
  • genetic or chromosomal abnormalities
  • metabolic contraindications for increased amount of protein

Sites / Locations

  • Hippokration Hospital Thessaloniki

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

protein intake of 4g/kg/d

Arm Description

Tailored protein fortification and nutritional status of preterm neonate. 4.5g protein per kg for preterms with body weight less than 1000g and 4g protein per kg for preterms with body weight more than 1000g, after human milk analysis. Intervention regards protein supplementation to fulfil the exact protein needs of preterms

Outcomes

Primary Outcome Measures

Mean protein intake per kg of body weight between the groups

Secondary Outcome Measures

growth assessment differences between groups
Anthropometric differences in body length, head circumference, body weight gain/kg, mid arm circumference
Differences in bioelectrical impedance between groups
Mean daily dietary intake of mothers and correlation with macronutrients of their's breast milk
Biochemical (lipidemic profile differences) between groups

Full Information

First Posted
September 10, 2013
Last Updated
July 12, 2016
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT01947972
Brief Title
Individualized Maternal Milk Fortification for Feeding the Preterm Infants
Official Title
Individualized Maternal Milk Fortification for Feeding the Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Neonatal nutrition has to face a contradictory and conflicting nutritional regimen like a high percentage of amino acids from the first day of life in order to achieve normal neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia, increased visceral fat) that this type feeding, in conjunction with complexity of prematurity, is likely to cause. Current study aims to investigate is whether individualized fortification of breast milk protein, based on the mother's milk protein content and targeting the recommended daily protein requirements, is associated with better nutrition, growth, biochemical and endocrine markers associated with the nutrition of preterm low birth weight neonates, compared to the standard fortification of human milk.
Detailed Description
Proteins are of the most important macromolecules in living organisms participating in almost all biological processes. Premature infants are forced to adapt to a new (extrauterine) environment where supply of nutrients, including amino acids, from mother ceases abruptly. Consequently, the aim of neonatologist is the appropriate, quantitatively and qualitatively nutritional support, to promote brain development, achieve normal endocrine and metabolic function, maintain a growth rate similar to the intrauterine one avoiding extrauterine growth restriction during postnatal period and at the same time encouraging the analogue modulation of body composition (increased muscle mass, decrease body fat, hydration). Malnutrition or inadequate nutrition of preterm infant which remains undiagnosed and without proper treatment could have serious consequences on psychomotor development and metabolic activity. Indeed, 75% of low birth weight premature infants exhibit extrauterine growth restriction at discharge, even when they have achieved growth equal to the considered satisfactory, ie 15g/kg/day. Beyond anthropometrics differences between preterm and full-term newborns, body composition varies as well. Preterms have higher percentage of body fat and decreased muscle mass at term time compared with full term neonates. However, it has not been clarified whether this differentiation is harmful predisposing to chronic diseases later in childhood or adult life (eg. obesity, metabolic syndrome).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
preterm neonate, tailored fortification, nutrition, maternal breast milk composition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
protein intake of 4g/kg/d
Arm Type
Other
Arm Description
Tailored protein fortification and nutritional status of preterm neonate. 4.5g protein per kg for preterms with body weight less than 1000g and 4g protein per kg for preterms with body weight more than 1000g, after human milk analysis. Intervention regards protein supplementation to fulfil the exact protein needs of preterms
Intervention Type
Dietary Supplement
Intervention Name(s)
Tailored protein fortification
Intervention Description
4-4.5g of protein/kg/d
Primary Outcome Measure Information:
Title
Mean protein intake per kg of body weight between the groups
Time Frame
participants will be followed until discharge and at 40 weeks post gestational age
Secondary Outcome Measure Information:
Title
growth assessment differences between groups
Description
Anthropometric differences in body length, head circumference, body weight gain/kg, mid arm circumference
Time Frame
participants will be followed until discharge and at 40 weeks post gestational age
Title
Differences in bioelectrical impedance between groups
Time Frame
participants will be followed until discharge and at 40 weeks post gestational age
Title
Mean daily dietary intake of mothers and correlation with macronutrients of their's breast milk
Time Frame
from the moment of intervention, at least once in 10days, and until the end of intervention
Title
Biochemical (lipidemic profile differences) between groups
Time Frame
at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infants with gestational age ≤ 34weeks very low birth weight (≤ 1500g) Exclusion Criteria: maternal health problems contradicting breastfeeding genetic or chromosomal abnormalities metabolic contraindications for increased amount of protein
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisavet Diamanti, Dr
Organizational Affiliation
AUTH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hippokration Hospital Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

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Individualized Maternal Milk Fortification for Feeding the Preterm Infants

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