Condition category
Pregnancy and Childbirth
Date applied
28/10/2009
Date assigned
25/11/2009
Last edited
04/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.rbht.nhs.uk/research/cteu/projects/neonatal-medicine/neon/

Contact information

Type

Scientific

Primary contact

Dr Sabita Uthaya

ORCID ID

Contact details

Chelsea and Westminster Hospital
3rd Floor
Lift bank B
369 Fulham Road
London
SW10 9NH
United Kingdom

Additional identifiers

EudraCT number

2009-016731-34

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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

20/05/2010

Overall trial end date

31/12/2013

Reason abandoned

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

Patient

Age group

Neonate

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27030860
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27099248

Publication citations

Additional files

Editorial Notes

21/04/2016: Publication reference added. 01/04/2016: Publication reference added. 11/05/2010: the overall trial start and end dates were changed from 10/01/2010 and 31/07/2013 to 20/05/2010 and 31/12/2013, respectively.