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Human Milk Fortifiers and Acid-Base Status

NCT ID: NCT00196482

Last Updated: 2006-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-02-28

Brief Summary

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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

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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.

Conditions

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Premature Birth

Keywords

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growth oral feeding nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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changing of fortifier

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

growing premature infants with a birth weight \< 2000g

Exclusion Criteria

congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation
Minimum Eligible Age

10 Days

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany

UNKNOWN

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Principal Investigators

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Christoph Fusch

Role: STUDY_CHAIR

Department of Neonatology, University Hospital Greifswald

Locations

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University Hospital

Greifswald, M-V, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christoph Fusch, Professor

Role: CONTACT

Phone: +49-3834-86-

Email: [email protected]

Jens Rochow, MD

Role: CONTACT

Phone: +49-3834-86-

Email: [email protected]

Facility Contacts

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Christoph Fusch, Prof. Dr.

Role: primary

Jens Rochow, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 33006765 (View on PubMed)

Other Identifiers

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Fortifier 01

Identifier Type: -

Identifier Source: org_study_id