The effects of aluminium exposure in the neonatal period on brain, cognition and bone health in children born preterm

ISRCTN	ISRCTN56018683
DOI	https://doi.org/10.1186/ISRCTN56018683
Protocol serial number	N0012146854
Sponsor	Department of Health
Funder	Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr CJ Edmonds
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neonatal Diseases: feeding
Intervention	1. Standard feeding solution 2. Specially constituted feeding solution
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target sample size at registration	80
Key inclusion criteria	Children born prematurely and require intravenous feeding
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2005

c/o Research & Development Office

London
WC1N 3JH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2009		Yes	No