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Human Milk Fortifiers and Acid-Base Status

Primary Purpose

Premature Birth

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

changing of fortifier

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring growth, oral feeding, nutrition

Eligibility Criteria

10 Days - 3 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: growing premature infants with a birth weight < 2000g Exclusion Criteria: congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation

Sites / Locations

University HospitalRecruiting

Outcomes

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

Full Information

NCT ID

NCT00196482

First Posted

September 13, 2005

Last Updated

September 11, 2006

Sponsor

University Medicine Greifswald

Collaborators

NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany

1. Study Identification

Unique Protocol Identification Number

NCT00196482

Brief Title

Human Milk Fortifiers and Acid-Base Status

Official Title

Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

June 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Medicine Greifswald

Collaborators

NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Birth

Keywords

growth, oral feeding, nutrition

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

changing of fortifier

Primary Outcome Measure Information:

Title

frequency of metabolic acidosis

Secondary Outcome Measure Information:

Title

need for oral bicarbonate administartion

Title

longitudinal growth

Title

weight gain

Title

amino acid levels in plasma an urine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Days

Maximum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: growing premature infants with a birth weight < 2000g Exclusion Criteria: congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christoph Fusch, Professor

Phone

+49-3834-86-

Ext

6420

fusch@uni-greifswald.de

First Name & Middle Initial & Last Name or Official Title & Degree

Jens Rochow, MD

Phone

+49-3834-86-

Ext

6427

rochow@uni-greifswald.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Fusch

Organizational Affiliation

Department of Neonatology, University Hospital Greifswald

Official's Role

Study Chair

Facility Information:

Facility Name

University Hospital

City

Greifswald

State/Province

M-V

ZIP/Postal Code

17485

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christoph Fusch, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Jens Rochow, MD

First Name & Middle Initial & Last Name & Degree

Helmut Kuester, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

33006765

Citation

Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

Results Reference

derived

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Human Milk Fortifiers and Acid-Base Status

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