Individualized Maternal Milk Fortification for Feeding the Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Aristotle University Of Thessaloniki
Sponsor:
Information provided by (Responsible Party):
Elisavet Parlapani, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01947972
First received: September 10, 2013
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Dietary Supplement: Tailored fortification and nutritional status of preterm neonate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Individualized Maternal Milk Fortification for Feeding the Preterm Infants

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
nutritional counseling Dietary Supplement: Tailored fortification and nutritional status of preterm neonate

Detailed Description:

Proteins are of the most importany 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).

  Eligibility

Ages Eligible for Study:   up to 5 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947972

Locations
Greece
Hippokration Hospital Thessaloniki Recruiting
Thessaloniki, Greece
Contact: Vasiliki Drosou-Agakidou, Dr    (0030)2310892426    agaki@med.auth.gr   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
  More Information

No publications provided

Responsible Party: Elisavet Parlapani, Dietitian - phD candidate, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01947972     History of Changes
Other Study ID Numbers: IKY5721
Study First Received: September 10, 2013
Last Updated: October 4, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:
preterm neonate
tailored fortification
nutrition
maternal breast milk composition

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014