Human Milk Fortifiers and Acid-Base Status
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants|
- frequency of metabolic acidosis
- need for oral bicarbonate administartion
- longitudinal growth
- weight gain
- amino acid levels in plasma an urine
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||February 2006|
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.
|Contact: Christoph Fusch, Professor||+49-3834-86- ext email@example.com|
|Contact: Jens Rochow, MD||+49-3834-86- ext firstname.lastname@example.org|
|Greifswald, M-V, Germany, 17485|
|Contact: Christoph Fusch, Prof. Dr.|
|Contact: Jens Rochow, MD|
|Sub-Investigator: Helmut Kuester, MD|
|Study Chair:||Christoph Fusch||Department of Neonatology, University Hospital Greifswald|