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Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.
Two different compositions are tested, main difference is in electrolyte composiiton.
Full description
Two groups each consisting of 15 infants with a birth weight below 2000g are studied.randomization is startified by three birth weigth classes (<1000g, 1000-1500g,1500 - 2000g) human milk fortifier is introduced in two steps after oral feeding is achieved. two acid-base status and electrolyte concentrations are measured. when metabolic acidosis, defined as BE < -6 mmol/l, occurs fortifier feeding is stopped, and after a wash-out period of three days the alternative product is used.again, occurence of metabolic acidosis, need for oral bicarbonate and effect on longitudinal growth an weight gain are registered.
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Inclusion criteria
growing premature infants with a birth weight < 2000g
Exclusion criteria
congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation
Primary purpose
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Central trial contact
Jens Rochow, MD; Christoph Fusch, Professor
Data sourced from clinicaltrials.gov
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