Nutritional Evaluation and Optimisation in Neonates

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN29665319
• Date of registration: 25/11/2009
• Prospective Registration: Yes
• Primary sponsor: Imperial College London (UK)
• Public title: Nutritional Evaluation and Optimisation in Neonates
• Scientific title: Amino acid regimen and intravenous lipid composition in preterm parenteral nutrition: a randomised controlled trial of Nutritional Evaluation and Optimisation in Neonates
• Date of first enrolment: 20/05/2010
• Target sample size: 160
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN29665319
• Study type: Interventional
• Study design: Multicentre randomised 2 x 2 factorial double-blind controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Sabita Uthaya

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Preterm birth
Pregnancy and Childbirth

Intervention(s)

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.

Primary Outcome(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

Secondary Outcome(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

Secondary ID(s)

2009-016731-34

EME 08/99/04; CRO1413

Source(s) of Monetary Support

Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/99/04)