Preterm birth Pregnancy and Childbirth
Conditions
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)
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
| Measure | Time 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
| Measure | Time 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