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Human Milk Fortifiers and Acid-Base Status

Premature Birth Clinical Trial

Official title:
Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00196482
Study type Interventional
Source University Medicine Greifswald
Contact Christoph Fusch, Professor
Phone +49-3834-86-
Email fusch@uni-greifswald.de
Status Recruiting
Phase N/A
Start date June 2004
Completion date February 2006
View Details
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