Individualized Maternal Milk Fortification for Feeding the Preterm Infants
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|ClinicalTrials.gov Identifier: NCT01947972|
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : July 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Dietary Supplement: Tailored protein fortification||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Individualized Maternal Milk Fortification for Feeding the Preterm Infants|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
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
- 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 ]
- growth assessment differences between groups [ Time Frame: participants will be followed until discharge and at 40 weeks post gestational age ]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 ]
- 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 ]
- Biochemical (lipidemic profile differences) between groups [ Time Frame: at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947972
|Hippokration Hospital Thessaloniki|
|Principal Investigator:||Elisavet Diamanti, Dr||AUTH|