Nutritional Evaluation and Optimisation in Neonates (NEON) v1.0

• Research type

  Research Study

• Full title

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

• IRAS ID

  31506

• Contact name

  Sabita Uthaya

• Sponsor organisation

  Imperial College

• Eudract number

  2009-016731-34

• ISRCTN Number

  to be confirmed

• Research summary

  Extremely preterm infants (born less than 31 weeks of gestation) spend several weeks and months in hospital. Feeding babies born so early is difficult. By the time they reach their due date their weight is about 1 kg (2 lbs) less than that of a full-term healthy baby. Food is initially provided as flud called parenteral nutrition (PN) that's given into a vein. As extremely preterm babies may have other medical problems, traditionally, the amount of nutrition provided in this way has been gradually increased in a cautious, stepwise manner. This means that it takes several days to reach the full recommended nutritional intake to enable them to grow.Though necessary, PN has complications, especially if used for a long time. One complication is damage to the liver. The type of fat used in PN may affect this. We believe that a better approach might be to give preterm babies the recommended amount of nutrition straight away without the stepwise approach, and to use a new type of fat (SMOF lipid) that contains soybean oil, olive and fish oil rather than the fat we currently use which has soybean oil alone (Intralipid). Although all these approaches to feeding are used by doctors in day to day practice, we do not know for sure if one has benefit over the other in preterm babies. Before this can be introduced into everyday practice as recommendations we need to make sure this approach is beneficial.The purpose of this study is to improve the growth and health of preterm babies. We will do this by: 1) comparing ??immediate? introduction of Parenteral Nutrition with ??stepwise? introduction2) comparing the currently used fat in PN, with a newer type of fat that we hope is less harmful to the liver.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0707/88

• Date of REC Opinion

  8 Dec 2009

• REC opinion

  Further Information Favourable Opinion