Human Milk Fortifiers and Acid-Base Status

September 11, 2006 updated by: University Medicine Greifswald

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

growing premature infants with a birth weight < 2000g

Exclusion Criteria:

congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
frequency of metabolic acidosis

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Collaborators

NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany

Investigators

  • Study Chair: Christoph Fusch, Department of Neonatology, University Hospital Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2006

Last Update Submitted That Met QC Criteria

September 11, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fortifier 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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