Nutritional Evaluation and Optimisation in Neonates

ISRCTN	ISRCTN29665319
DOI	https://doi.org/10.1186/ISRCTN29665319
Clinical Trials Information System (CTIS)	2009-016731-34
Protocol serial number	EME 08/99/04; CRO1413
Sponsor	Imperial College London (UK)
Funder	Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/99/04)

Submission date: 28/10/2009
Registration date: 25/11/2009
Last edited: 04/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sabita Uthaya
Scientific

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

Study information

Primary study design	Interventional
Study design	Multicentre randomised 2 x 2 factorial double-blind controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Amino acid regimen and intravenous lipid composition in preterm parenteral nutrition: a randomised controlled trial of Nutritional Evaluation and Optimisation in Neonates
Study acronym	NEON
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	160
Key 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
Key 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
Date of first enrolment	20/05/2010
Date of final enrolment	31/12/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Chelsea and Westminster Hospital

London
SW10 9NH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/03/2016		Yes	No
Results article	results	01/06/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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.