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Completed

NCT Number: NCT01947972

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.

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Key information

Age range

24 hour–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hippokration Hospital Thessaloniki

Thessaloniki, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored protein fortification

Dietary Supplement

4-4.5g of protein/kg/d

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Differences in bioelectrical impedance between groups

    Time frame: participants will be followed until discharge and at 40 weeks post gestational age

  3. 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

  4. Biochemical (lipidemic profile differences) between groups

    Time frame: at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2013
Registry last updated
Jul 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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