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Nutritional Evaluation and Optimisation in Neonates

Amino acid regimen and intravenous lipid composition in preterm parenteral nutrition: a randomised controlled trial of Nutritional Evaluation and Optimisation in Neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN29665319
Enrollment
160
Registered
2009-11-25
Start date
2010-05-20
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm birth Pregnancy and Childbirth

Interventions

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 amin

Sponsors

Imperial College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 13, 2026