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Clinical Trials/NCT01947972
NCT01947972
Completed
Not Applicable

Individualized Maternal Milk Fortification for Feeding the Preterm Infants

Aristotle University Of Thessaloniki1 site in 1 country60 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Aristotle University Of Thessaloniki
Enrollment
60
Locations
1
Primary Endpoint
Mean protein intake per kg of body weight between the groups
Status
Completed
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elisavet Parlapani

Dietitian - phD candidate

Aristotle University Of Thessaloniki

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

Outcomes

Primary Outcomes

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 Outcomes

  • growth assessment differences between groups(participants will be followed until discharge and at 40 weeks post gestational age)
  • Differences in bioelectrical impedance between groups(participants will be followed until discharge and at 40 weeks post gestational age)
  • Mean daily dietary intake of mothers and correlation with macronutrients of their's breast milk(from the moment of intervention, at least once in 10days, and until the end of intervention)
  • Biochemical (lipidemic profile differences) between groups(at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age)

Study Sites (1)

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