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Individualized Maternal Milk Fortification for Feeding the Preterm Infants

Individualized Maternal Milk Fortification for Feeding the Preterm Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01947972
Enrollment
60
Registered
2013-09-23
Start date
2013-10-31
Completion date
2016-07-31
Last updated
2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

preterm neonate, tailored fortification, nutrition, maternal breast milk composition

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).

Interventions

DIETARY_SUPPLEMENTTailored protein fortification

4-4.5g of protein/kg/d

Sponsors

Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Hours to 5 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Mean protein intake per kg of body weight between the groupsparticipants will be followed until discharge and at 40 weeks post gestational age

Secondary

MeasureTime frameDescription
growth assessment differences between groupsparticipants will be followed until discharge and at 40 weeks post gestational ageAnthropometric differences in body length, head circumference, body weight gain/kg, mid arm circumference
Differences in bioelectrical impedance between groupsparticipants 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 milkfrom the moment of intervention, at least once in 10days, and until the end of intervention
Biochemical (lipidemic profile differences) between groupsat 36weeks post conceptual age and follow-up at 40 weeks postconceptual age

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026