Plain English Summary
Not provided at time of registration
Study website
http://www.rbht.nhs.uk/research/cteu/projects/neonatal-medicine/neon/
Additional identifiers
EudraCT/CTIS number
2009-016731-34
IRAS number
ClinicalTrials.gov number
Protocol/serial number
EME 08/99/04; CRO1413
Study information
Scientific title
Amino acid regimen and intravenous lipid composition in preterm parenteral nutrition: a randomised controlled trial of Nutritional Evaluation and Optimisation in Neonates
Acronym
NEON
Study hypothesis
Introduction of recommended daily intake (RDI) of amino acids will lead to an increase in non-adipose (lean) body mass; administration of SMOFLIPID® will reduce intrahepatocellular lipid content (IHCL) in preterm babies at term age equivalent.
Link to EME project website: http://www.eme.ac.uk/projectfiles/089904info.pdf
Protocol can be found at: http://www.eme.ac.uk/projectfiles/089904protocol.pdf
Ethics approval(s)
Hammersmith Research Ethics Committee, 08/12/2009
Study design
Multicentre randomised 2 x 2 factorial double-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Preterm birth
Intervention
Eligible preterm infants will be randomised by 24 hours of age (previously 12 hours of age, updated 02/07/2013) to receive:
1. Either incremental amino acids in parenteral nutrition or the RDI of amino acids from day one, and
2. Either 20% intralipid or 20% SMOFLIPID®
There will be four groups:
Group 1: incremental amino acid and 20% intralipid
Group 2: incremental amino acid and 20% SMOFLIPID®
Group 3: RDI of amino acids and 20% intralipid
Group 4: RDI of amino acids and 20% SMOFLIPID®
Infants will be followed from birth and until they reach 37 - 44 weeks corrected age at which point the final study assessment (magnetic resonance imaging [MRI] scan) takes place.
Intervention type
Supplement
Primary outcome measure
1. For the amino acid intervention: non-adipose (lean) body mass measured by whole body MRI at term age equivalent
2. For the lipid intervention: hepatic magnetic resonance spectroscopy (MRS) to measure IHCL at term age equivalent
Secondary outcome measures
1. Anthropometry (weight, length and head circumference) measured at term age equivalent
2. Brain MRI (brain volumes, white matter apparent diffusion co-efficient values, cerebral vessel tortuosity) measured at term age equivalent
3. Metabolic index of insulin resistance at term age equivalent (quantitative insulin-sensitivity check index [QUICKI]), calculated using fasting serum glucose and insulin
Added 07/12/2009:
4. Ratio of internal to subcutaneous adipose tissue at term age equivalent.
5. Serum triglyceride and serum bilirubin levels.
Added 11/05/2010:
6. Metabonomic profile
7. Incidence of death
8. Number of infants with incomplete follow-up
Added 24/03/2011:
9. Inflammatory markers and lipid profile
Overall study start date
20/05/2010
Overall study end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Preterm infants (either sex) born below 31 weeks of gestation (defined as less than or equal to 30 weeks and 6 days)
2. Written informed consent from parents
Participant type(s)
Patient
Age group
Neonate
Sex
Both
Target number of participants
160 infants
Participant exclusion criteria
1. Major congenital or life threatening abnormalities
2. Inability to randomise in time to allow administration of trial parenteral nutrition (PN) within 24 hours of birth
Recruitment start date
20/05/2010
Recruitment end date
31/12/2013
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Chelsea and Westminster Hospital
London
SW10 9NH
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
South Kensington
London
SW7 2AZ
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/99/04)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2016 | Yes | No | |
| Results article | results | 01/06/2016 | Yes | No |