Human Milk Fortifiers and Acid-Base Status

This study is currently recruiting participants.

Verified by Ernst Moritz Arndt University of Greifswald, September 2005

First Received: September 13, 2005 Last Updated: September 11, 2006 History of Changes

Sponsors and Collaborators:	Ernst Moritz Arndt University of Greifswald NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany
Information provided by:	Ernst Moritz Arndt University of Greifswald
ClinicalTrials.gov Identifier:	NCT00196482

Purpose

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.

Condition	Intervention
Premature Birth	Drug: changing of fortifier

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants

Further study details as provided by Ernst Moritz Arndt University of Greifswald:

Primary Outcome Measures:

frequency of metabolic acidosis

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	June 2004
Estimated Study Completion Date:	February 2006

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.

Eligibility

Ages Eligible for Study:	up to 3 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

growing premature infants with a birth weight < 2000g

Exclusion Criteria:

congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196482

Contacts

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

Locations

Germany, M-V
University Hospital	Recruiting
Greifswald, M-V, Germany, 17485
Contact: Christoph Fusch, Prof. Dr.
Contact: Jens Rochow, MD
Sub-Investigator: Helmut Kuester, MD

Sponsors and Collaborators

Ernst Moritz Arndt University of Greifswald

NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany

Investigators

Study Chair:

Christoph Fusch

Department of Neonatology, University Hospital Greifswald

More Information

No publications provided

Study ID Numbers:	Fortifier 01
Study First Received:	September 13, 2005
Last Updated:	September 11, 2006
ClinicalTrials.gov Identifier:	NCT00196482 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ernst Moritz Arndt University of Greifswald:

growth
oral feeding
nutrition

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

Additional relevant MeSH terms:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on September 03, 2009