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Status unknownNCT00196482Updated Sep 12, 2006

Human Milk Fortifiers and Acid-Base Status

An interventional study of changing of fortifier in Premature Birth, sponsored by University Medicine Greifswald. Status unknown at 1 site in Germany. Open to participants aged 10 Days to 3 Months. Per ClinicalTrials.gov, last updated 2006-09-12.

Sponsored by University Medicine Greifswald · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
10 Days to 3 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Premature Birth

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Keywords

  • growth
  • oral feeding
  • nutrition
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 30 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

University Medicine Greifswald is the lead sponsor of 149 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Days to 3 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

growing premature infants with a birth weight \< 2000g

Exclusion criteria

Exclusion Criteria:

congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
30 participants

Interventions

  • Drugchanging of fortifier
06

What researchers measure

Primary outcomes

  1. frequency of metabolic acidosis

Secondary outcomes

  1. need for oral bicarbonate administartion

  2. longitudinal growth

  3. weight gain

  4. amino acid levels in plasma an urine

07

Study locations

1 of 1 sites recruiting
  • University Hospital
    Greifswald, M-V 17485, Germany
    • Christoph Fusch, Prof. Dr. · Contact
    • Jens Rochow, MD · Contact
    • Helmut Kuester, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 33006765 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00196482
Lead sponsor
University Medicine Greifswald
Collaborators
NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany
First posted
Sep 20, 2005
Start date
Jun 2004
Completion
Feb 2006
Last update
Sep 12, 2006

Study contacts

Christoph Fusch, Professor
Contact
fusch@uni-greifswald.de
+49-3834-86- ext. 6420
Jens Rochow, MD
Contact
rochow@uni-greifswald.de
+49-3834-86- ext. 6427
Christoph Fusch
study chair · Department of Neonatology, University Hospital Greifswald
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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