Condition category
Neonatal Diseases
Date applied
06/09/2005
Date assigned
13/09/2005
Last edited
30/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Neena Modi

ORCID ID

Contact details

Imperial College London
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Breast milk fortifier containing LCPUFA has a measurable effect upon body composition at term when compared with non-LCPUFA supplemented fortifier

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Preterm infants

Intervention

Infants will receive maternal +/- donor breast milk; should breast milk fortifier be indicated in accordance with normal clinical practice, infants will be randomised to receive standard fortifier or LCPUFA supplemented fortifier.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Body composition at age term-equivalent

Secondary outcome measures

Growth, metabolic profile, intrahepatocellular lipid content, brain growth and development, neurological examination

Overall trial start date

01/08/2005

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Infants born at or below 32 weeks gestational age

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

120 of whom 42 will be randomised

Participant exclusion criteria

1. Major congenital abnormality

2. Mother does not wish to provide breast milk or to use donor milk
3. Baby requires gastrointestinal surgery

Recruitment start date

01/08/2005

Recruitment end date

30/06/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Imperial College London
London
SW10 9NH
United Kingdom

Sponsor information

Organisation

Milupa GmbH, Numico Research (Germany)

Sponsor details

Bahnstrasse 14-30
Friedrichsdorf
61381
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Numico Research Germany

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes