Effect of extra intravenous (IV) nutrition compared to standard IV nutrition on growth in moderately preterm babies
A randomised controlled trial comparing the effect on growth of peripheral parenteral nutrition versus 10% glucose during the transition to enteral feeds in moderately preterm infants. The P-PN Study
Women's and Children's Health Network
90 participants
Sep 13, 2016
Interventional
Conditions
Summary
Many babies are born early for a variety of reasons. These premature babies have more problems with growth and later development than other babies born at term. Babies born between 6 and 10 weeks early miss out on the important nutrition from the placenta. In addition, these newborn babies often lose further weight in the first week of life. Despite these recognised problems there is very little research about how best to address these issues. At present, these babies receive a simple sugar and water solution through an IV line whilst building up oral feeds with either breast milk or artificial formula. As a result many babies lose weight but also protein and fat as the simple sugar and water solution is unable to provide these babies with the more complex mixture of dietary supplementation they require. It is the purpose of this study to provide premature babies born between 6 and 10 weeks early with a more complex dietary infusion delivered through an IV line to improve their nutrition and reduce weight loss after premature birth. Ninety babies will be enrolled in the study with each having an equal chance of receiving either the routine sugar and water IV solution or a combined solution of sugar, protein, fat and water also through an IV line. The baby’s growth will be monitored up to three weeks of age. This study will provide important information about how best to improve the nutrition in premature babies, which we hope will also improve their longer term outcomes.
Eligibility
Plain Language Summary
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Interventions
Peripherally administered intravenous peripheral parenteral nutrition (amino acid, glucose 8% and lipids). The P-PN Study solution will be prepared by Baxter and consist of Primene 30g/L, glucose 80g/L and Heparin 500IU/L. It will be administered at maxmimum rate of 100mL/kg/d, which will give a maximum protein dose of 3 g/kg/d. The lipid solution is a 17% fat emulsion with added vitamins for injection (SMOFlipid 20% 15ml, Vitalipid N Infant 4ml and Soluvit N 1ml per 20ml. (Fresenius Kabi) It will be manufactured on site at WCH Sterile Manufacturing Pharmacy. It will be administered at a dose of lipid of 2 g/kg/d. The study and standard solutions will be administered as continuous IV infusions. When consent, and randomisation has been confirmed, the study fluids will be commenced or the standard fluid will be continued. The lipid infusion will cease when feeds are 100mL/kg/d, and the P-PN Study fluid will cease when the feeds are 100mL/kg/d. Registered nurses or Registered Midwifes from the Neonatal Unit will administer the study fluids. The study will occur in the Neonatal intensive care unit (NICU) or special care baby unit (SCBU) at the Women's and Children's Hospital, Adelaide. The study IV solutions will commence at a total of 45-60mLkg/d and increase 10-15mL/kg/d until full enteral feeds are established. At the clinician's discretion the study fluids will be titrated if there is feed intolerance, or evidence of fluid/nutrition/electrolyte disturbance - for example - fluid overload, increased fluid need, lipid intolerance, hypoglycaemia, or hyperglycaemia. Protocol adherence checked daily by research nurse
Locations(2)
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ACTRN12616000925448