Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Individualized Maternal Milk Fortification for Feeding the Preterm Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elisavet Parlapani, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01947972
First received: September 10, 2013
Last updated: July 12, 2016
Last verified: July 2016

September 10, 2013
July 12, 2016
October 2013
July 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01947972 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Individualized Maternal Milk Fortification for Feeding the Preterm Infants
Individualized Maternal Milk Fortification for Feeding the Preterm Infants
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.

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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Metabolic Syndrome
Dietary Supplement: Tailored protein fortification
4-4.5g of protein/kg/d
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
Intervention: Dietary Supplement: Tailored protein fortification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2016
July 2016   (final data collection date for primary outcome measure)

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
Both
up to 5 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01947972
IKY5721
No
Not Provided
Not Provided
Elisavet Parlapani, Aristotle University Of Thessaloniki
Aristotle University Of Thessaloniki
Not Provided
Principal Investigator: Elisavet Diamanti, Dr AUTH
Aristotle University Of Thessaloniki
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP