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 |
| Secondary identifying numbers | N0012146854 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 19/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr CJ Edmonds
Scientific
Scientific
c/o Research & Development Office
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | Participants: 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
c/o Research & Development Office
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2009 | Yes | No |
