Clinical trial NCT01947972: Individualized Maternal Milk Fortification for Feeding the Preterm Infants
Official title: Individualized Maternal Milk Fortification for Feeding the Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: preterm neonate
tailored fortification
nutrition
maternal breast milk composition
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Mean protein intake per kg of body weight between the groups
timeFrame: participants will be followed until discharge and at 40 weeks post gestational age
Secondary outcomes:
measure: growth assessment differences between groups
timeFrame: participants will be followed until discharge and at 40 weeks post gestational age
measure: Differences in bioelectrical impedance between groups
timeFrame: participants will be followed until discharge and at 40 weeks post gestational age
measure: Mean daily dietary intake of mothers and correlation with macronutrients of their's breast milk
timeFrame: from the moment of intervention, at least once in 10days, and until the end of intervention
measure: Biochemical (lipidemic profile differences) between groups
timeFrame: at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Hippokration Hospital Thessaloniki
Study officials:
affiliation: AUTH
name: Elisavet Diamanti, Dr
role: PRINCIPAL_INVESTIGATOR
References: