NCT00196482

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

September 12, 2006

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 11, 2006

Conditions

Premature Birth

Keywords

growthoral feedingnutrition

Outcome Measures

Primary Outcomes (1)

  • frequency of metabolic acidosis

Secondary Outcomes (4)

  • need for oral bicarbonate administartion

  • longitudinal growth

  • weight gain

  • amino acid levels in plasma an urine

Interventions

changing of fortifierDRUG

Eligibility Criteria

Age10 Days - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • growing premature infants with a birth weight \< 2000g

You may not qualify if:

  • congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Greifswald, M-V, 17485, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33006765DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Christoph Fusch

    Department of Neonatology, University Hospital Greifswald

    STUDY CHAIR

Central Study Contacts

Christoph Fusch, Professor

CONTACT

+49-3834-86-fusch@uni-greifswald.de

Jens Rochow, MD

CONTACT

+49-3834-86-rochow@uni-greifswald.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

June 1, 2004

Study Completion

February 1, 2006

Last Updated

September 12, 2006

Record last verified: 2005-09

Locations

DE(1)