Individualized Maternal Milk Fortification for Feeding the Preterm Infants

NCT01947972 | Completed

• 1 other identifier: IKY5721
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome

Keywords

preterm neonate; tailored fortification; nutrition; maternal breast milk composition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• growth assessment differences between groups

  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

Study Arms (1)

protein intake of 4g/kg/d

OTHER

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

Interventions

Tailored protein fortification DIETARY_SUPPLEMENT

4-4.5g of protein/kg/d

protein intake of 4g/kg/d

Eligibility Criteria

• Age: 24 Hours - 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants with gestational age ≤ 34weeks
• very low birth weight (≤ 1500g)

You may not qualify if:

• maternal health problems contradicting breastfeeding
• genetic or chromosomal abnormalities
• metabolic contraindications for increased amount of protein

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Hippokration Hospital Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Elisavet Diamanti, Dr

  AUTH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian - phD candidate

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 23, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

GR (1)