Individualized Maternal Milk Fortification for Feeding the Preterm Infants

Metabolic Syndrome Clinical Trial

Official title:

Individualized Maternal Milk Fortification for Feeding the Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947972
• Other study ID #: IKY5721
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: July 12, 2016
• Start date: October 2013
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• Tailored protein fortification
4-4.5g of protein/kg/d

Locations

Country	Name	City	State
Greece	Hippokration Hospital Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean protein intake per kg of body weight between the groups		participants will be followed until discharge and at 40 weeks post gestational age	No
Secondary	growth assessment differences between groups	Anthropometric differences in body length, head circumference, body weight gain/kg, mid arm circumference	participants will be followed until discharge and at 40 weeks post gestational age	No
Secondary	Differences in bioelectrical impedance between groups		participants will be followed until discharge and at 40 weeks post gestational age	No
Secondary	Mean daily dietary intake of mothers and correlation with macronutrients of their's breast milk		from the moment of intervention, at least once in 10days, and until the end of intervention	No
Secondary	Biochemical (lipidemic profile differences) between groups		at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age	No