Human Milk Fortifiers and Acid-Base Status

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Medicine Greifswald.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00196482
First received: September 13, 2005
Last updated: September 11, 2006
Last verified: September 2005

September 13, 2005
September 11, 2006
June 2004
Not Provided
frequency of metabolic acidosis
Same as current
Complete list of historical versions of study NCT00196482 on ClinicalTrials.gov Archive Site
  • need for oral bicarbonate administartion
  • longitudinal growth
  • weight gain
  • amino acid levels in plasma an urine
Same as current
Not Provided
Not Provided
 
Human Milk Fortifiers and Acid-Base Status
Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Premature Birth
Drug: changing of fortifier
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
February 2006
Not Provided

Inclusion Criteria:

growing premature infants with a birth weight < 2000g

Exclusion Criteria:

congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation

Both
up to 3 Months
No
Contact: Christoph Fusch, Professor +49-3834-86- ext 6420 fusch@uni-greifswald.de
Contact: Jens Rochow, MD +49-3834-86- ext 6427 rochow@uni-greifswald.de
Germany
 
NCT00196482
Fortifier 01
Not Provided
Not Provided
University Medicine Greifswald
NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany
Study Chair: Christoph Fusch Department of Neonatology, University Hospital Greifswald
University Medicine Greifswald
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP