Human Milk Fortifiers and Acid-Base Status

Not Applicable

• Conditions: Premature Birth

• Registration Number: NCT00196482
• Lead Sponsor: University Medicine Greifswald

Brief 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.

Detailed 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 Timeline

• Study Start: 2004-06
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-20
• Study Completion: 2006-02
• Last Update Submitted: 2006-09-11
• Last Update Posted: 2006-09-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

growing premature infants with a birth weight < 2000g

Exclusion Criteria

congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
frequency of metabolic acidosis

Secondary Outcome Measures

Name	Time	Method
need for oral bicarbonate administartion
longitudinal growth
weight gain
amino acid levels in plasma an urine

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Greifswald, M-V, Germany