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NCT00196482 Clinical Trial

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 Details — Status: Recruiting

Administrative data
NCT number NCT00196482
Other study ID # Fortifier 01
Secondary ID
Status Recruiting
Phase N/A
First received September 13, 2005
Last updated September 11, 2006
Start date June 2004
Est. completion date February 2006

Study information
Verified date September 2005
Source University Medicine Greifswald
Contact Christoph Fusch, Professor
Phone +49-3834-86-
Email fusch@uni-greifswald.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Months
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• changing of fortifier

Locations
Country Name City State
Germany University Hospital Greifswald M-V

Sponsors (2)
Lead Sponsor Collaborator
University Medicine Greifswald NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary frequency of metabolic acidosis
Secondary need for oral bicarbonate administartion
Secondary longitudinal growth
Secondary weight gain
Secondary amino acid levels in plasma an urine
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