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
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants

Further study details as provided by University Medicine 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
University Medicine Greifswald
NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany
Investigators
Study Chair: Christoph Fusch Department of Neonatology, University Hospital Greifswald
  More Information

No publications provided

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

Keywords provided by University Medicine Greifswald:
growth
oral feeding
nutrition

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on August 28, 2014