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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Tailored protein fortification

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece
    • Hippokration Hospital Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 5 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean protein intake per kg of body weight between the groups	participants will be followed until discharge and at 40 weeks post gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Differences in bioelectrical impedance between groups		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		from the moment of intervention, at least once in 10days, and until the end of intervention
Biochemical (lipidemic profile differences) between groups		at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: Elisavet Diamanti, Dr, AUTH

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 19, 2013
• First Posted (Estimate): September 23, 2013

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: nutrition; preterm neonate; tailored fortification; maternal breast milk composition
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: IKY5721