Condition category
Neonatal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
19/04/2011
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

Dr CJ Edmonds

ORCID ID

Contact details

c/o Research & Development Office
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0012146854

Study information

Scientific title

Acronym

Study hypothesis

This study sets out to investigate whether aluminium toxicity due to contaminate of intravenous feeding solutions cause long lasting adverse effects on brain, cognition and bone health.

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

Neonatal Diseases: feeding

Intervention

1. Standard feeding solution
2. Specially constituted feeding solution

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Children born prematurely and require intravenous feeding

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

Participants: 80

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2004

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o Research & Development Office
London
WC1N 3JH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19858156

Publication citations

  1. Results

    Fewtrell MS, Bishop NJ, Edmonds CJ, Isaacs EB, Lucas A, Aluminum exposure from parenteral nutrition in preterm infants: bone health at 15-year follow-up., Pediatrics, 2009, 124, 5, 1372-1379, doi: 10.1542/peds.2009-0783.

Additional files

Editorial Notes