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Individualized Maternal Milk Fortification for Feeding the Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01947972
First Posted: September 23, 2013
Last Update Posted: July 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elisavet Parlapani, Aristotle University Of Thessaloniki
  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 protein fortification

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Elisavet Parlapani, 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 ]

Secondary Outcome Measures:
  • growth assessment differences between groups [ Time Frame: participants will be followed until discharge and at 40 weeks post gestational age ]
    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 ]
  • 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 ]
  • Biochemical (lipidemic profile differences) between groups [ Time Frame: at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age ]

Enrollment: 60
Study Start Date: October 2013
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947972


Locations
Greece
Hippokration Hospital Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Elisavet Diamanti, Dr AUTH
  More Information

Responsible Party: Elisavet Parlapani, Dietitian - phD candidate, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01947972     History of Changes
Other Study ID Numbers: IKY5721
First Submitted: September 10, 2013
First Posted: September 23, 2013
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Elisavet Parlapani, 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