None listed
Conditions
Brief summary
During periods of acute illness in term (= 37 weeks’ gestation) and late preterm infants (between 34 to 37 weeks’ gestation), provision of sufficient enteral nutrition is unachievable, which necessitates the use of parenteral nutrition (PN). PN involves the administration of glucose, amino acids, lipids and various micronutrients. More than 200 babies receive PN in the Neonatal Intensive Care Unit (NICU) at Perth Children’s Hospital (PCH) each year, accounting for up to 1400 PNs annually. In very preterm infants (< 32 weeks’ gestation), nutrition has been extensively researched and hence there is adequate evidence recommending early commencement of PN. However, there is a lack of evidence regarding the optimal time to commence PN therapy in term and late preterm infants. Hence, there are no clinical guidelines for this population. Moreover, nutritional reserve, requirements and morbidity of very preterm infants are different to that of term and late preterm infants. Therefore, it is inappropriate to extrapolate the nutritional recommendations of very preterm infants to term and late preterm infants. The potential benefits of early amino acids include the prevention of catabolism, reduction in hypoglycaemia, improved growth and neurodevelopmental outcomes. Potential harms associated with early amino acids include hyperammonaemia, azotaemia, and metabolic acidosis. The potential benefits of early lipids include the prevention of essential fatty acid (EFA) deficiency, improve nutrition, increase long chain polyunsaturated fatty acids (LCPUFA) and improved neurodevelopmental outcomes. Potential harms associated with early lipids include increased risk of sepsis, worsening of pulmonary hypertension and respiratory function. Therefore, we plan to conduct a randomised controlled trial (RCT) that evaluates the benefits and risks of early versus late PN in term and late preterm infants by comparing relevant biochemical and clinical outcomes. We will also conduct a cost analysis of early versus late PN from a Western Australian (WA) public hospital perspective.
Interventions
‘Late Parenteral Nutrition (PN)’
Infants randomised to ‘Late PN’ will commence PN only after the completion of Day 5 (i.e.120 hours) of NICU admission.
If an infant randomised to ‘late PN’ does not require PN after Day 5, the infant will still be included as being in the ‘Late PN’ group and analysed as such.
PN will be defined as the administration of any amount of intravenous amino acids and/or lipid emulsion. Administration of PN is either via peripheral intravenous cannula or central venou
‘Late Parenteral Nutrition (PN)’ Infants randomised to ‘Late PN’ will commence PN only after the completion of Day 5 (i.e.120 hours) of NICU admission. If an infant randomised to ‘late PN’ does not require PN after Day 5, the infant will still be included as being in the ‘Late PN’ group and analysed as such. PN will be defined as the administration of any amount of intravenous amino acids and/or lipid emulsion. Administration of PN is either via peripheral intravenous cannula or central venous access device. Prescription of PN (including type of PN, dosage and rate of administration) will be determined by the treating clinician on a daily basis, depending on the infant’s clinical progress and according to the KEMH/PCH Neonatology Guidelines (Nutrition: Volume and Nutritional Requirements AND Parenteral Nutrition. All PN formulations will be prepared by the Pharmacy Department at PCH or an external compounding provider. PN may be ‘Standard PN’ or ‘Non- standard PN’. ‘Standard PN’ consists of predetermined amounts of glucose, amino acids and standard concentrations of electrolytes, trace elements, vitamins and heparin. If clinically indicated, ‘Non-standard PN’ may be ordered by the treating clinician to allow modifications. SMOF 17% consisting of soya oil (30%), medium chain triglyceride (30%), refined olive oil (25%) and fish oil (15%) will be used as the source of parenteral lipids. Both fat soluble (Soluvit N®) and water soluble vitamins (Vitalipid N®) will be added to the lipid emulsion (SMOF®). Infants randomised to the ‘early PN’ group will receive PN formulation as prescribed by the treating doctor within the 48 hours of admission to NICU. Infants randomised to the ‘late PN’ group, will receive glucose and sodium chloride solutions at a rate, as per infant’s needs up to Day 5 and then commence PN from Day 6 of admission to NICU. PN will be prescribed by NICU registrar/senior registrar/consultant and administered by NICU nursing staff according to the KEMH/PCH Neonatology Guidelines: Volume and Nutritional Requirements. Administration of PN and glucose, sodium and other electrolytes will be titrated according to routine biochemical results (examples: blood glucose, serum sodium, potassium, magnesium, calcium) by the treating clinician. All PN charts will be reviewed daily by the research team to ensure each prescription is ordered, prepared and administered correctly.
Sponsors
Perth Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 28 Days
Healthy volunteers
No
Inclusion criteria
Infants will be eligible for study inclusion it they meet all of the following inclusion criteria: (1) All term or late preterm infants, born >=34 weeks of gestation at birth until day 28 of life admitted to NICU who have high likelihood of being unable to tolerate full enteral feeds for at least three to five days and hence require parenteral nutrition (PN) (2) Informed parental/legal guardian consent
Exclusion criteria
Infants will be excluded from participation in the trial if they meet any one or more of the following exclusion criteria: (1) Infants > 28 days of life; (2) Preterm infants (born at <34 weeks of gestation); (3) Infants who received PN from a referring hospital; (4) Infants with suspected inborn error of metabolism.
Outcome results
None listed