Individualized Maternal Milk Fortification for Feeding the Preterm Infants
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Individualized Maternal Milk Fortification for Feeding the Preterm Infants|
- 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 ] [ Designated as safety issue: No ]
- growth assessment differences between groups [ Time Frame: participants will be followed until discharge and at 40 weeks post gestational age ] [ Designated as safety issue: No ]Anthropometric differences in body length, head circumference, body weight gain/kg, mid arm circumference
- Differences in bioelectrical impedance between groups [ Time Frame: participants will be followed until discharge and at 40 weeks post gestational age ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Biochemical (lipidemic profile differences) between groups [ Time Frame: at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Study Completion Date:||July 2016|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
protein intake of 4g/kg/d
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
Dietary Supplement: Tailored protein fortification
4-4.5g of protein/kg/d
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01947972
|Hippokration Hospital Thessaloniki|
|Principal Investigator:||Elisavet Diamanti, Dr||AUTH|