• PN is the provision of nutrients through intravenous administration including amino acids, glucose, lipids, electrolytes, vitamins and trace elements

• Using PN allows the provision of optimal nutrition early in life, which minimises growth failure and associated neuro-cognitive defects

• It is preferable for PN to be administered via central intravenous access

• Most babies who need PN can and should receive standard PN bags

• Bespoke scratch PN may be used in exceptional circumstances Requests for PN must be communicated to pharmacy by 10am to ensure sufficient stock

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Abbreviations

Scope of document

Parenteral Nutrition (PN) is an essential aspect of neonatal care by which an infant’s nutritional requirements can be met intravenously. Using PN allows the provision of optimal nutrition early in life, which minimises growth failure and associated neuro-cognitive defects.

Infants may require PN because of prematurity and the inability of the immature gut to digest sufficient milk, or because they cannot tolerate enteral feeds due to congenital/ acquired gut disorders, necrotising enterocolitis (NEC) or post-surgery.

Using a standardised approach to the provision of neonatal PN offers several advantages:

• Nutrient delivery in line with national and international guidance (NICE, BAPM, ESPGHAN).

• Availability of ready-made standard PN formulations avoids delays in initiation and administration.

• Minimised risk of errors in prescribing and compounding.

The following guideline has been developed to provide information on the use of PN, including how to prescribe, monitor and utilise PN in appropriate patients.

Definitions

PARENTERAL NUTRITION (PN): the provision of nutrients through the intravenous route including amino acids, glucose, lipids, electrolytes, vitamins and trace elements. PN should be given centrally via a central venous line where possible. Infants may also receive enteral feeds whilst PN is infusing, as they endeavour to build up their enteral feed tolerance, whilst PN is weaned.

TOTAL PARENTERAL NUTRITION (TPN): the patient’s complete nutritional needs are provided intravenously (all macro and micronutrients), and nutrition is not given by any other route other than intravenously.

SCRATCH BAGS: These are bespoke formulations for specific patients. These are only used in exceptional circumstances when the stock PN bags are not suitable for the needs of the patient.

Responsibilities

The consultant reviews infant and assesses if PN is required on the daily ward round. Thereafter, PN prescriptions are prescribed by the medical team or ward pharmacist (if an independent prescriber and competent in prescribing PN for infants) and biochemistry, body weight and fluid balance are reviewed appropriately.

The ward pharmacist must ensure the stock PN is always available and provide support and advice on prescribing.

The ward dietitian provides advice on the individual nutritional needs of babies if ‘scratch’ bags are required, working alongside the ward pharmacist and medical team with the prescription and ordering of PN.

Following NICE guidance:

Absolute indications – PN should be initiated for

1. All preterm infants born before 31+0 weeks or with birthweight less than 1500g.

2. Failure to establish enteral nutrition by day 5 of life (regardless of gestation or birthweight).

3. Preterm or term infants who are unlikely to establish sufficient enteral feeding, for example, infants with:

   1. a congenital gut disorder

   2. a critical illness.

Relative indications – Consider initiating PN for

1. Preterm infants born at or after 31+0 weeks or with birthweight greater than 1500g in whom there is insufficient progress with enteral feeding by 72 hours of life.

2. Preterm infants who develop an inability to tolerate enteral feeds and are unlikely to restart enteral feeds within 48 hours.

3. Term infants who develop an inability to tolerate enteral feeds and are unlikely to restart enteral feeds within 72 hours.

Cautions – Discuss with the responsible consultant and (if possible) a neonatal pharmacist before prescribing

1. Significant renal impairment/renal failure.

2. Suspicion of a metabolic disorder.

3. Significant septicaemia.

4. Hyperbilirubinemia requiring exchange transfusion.

Review the following NICE algorithms for further details.

Neonatal parenteral nutrition for preterm babies, up to 28 days after their due birth date

NG154 Neonatal parenteral nutrition for preterm babies, up to 28 days after their due birth date algorithm

Neonatal parenteral nutrition for term babies, up to 28 days after their birth

NG154 Neonatal parenteral nutrition for term babies, up to 28 days after their birth algorithm

The standard PN formulations stocked at FHFT are presented as a separate aqueous solution in an infusion bag and the fat/ lipid emulsion is supplied in a bag/ syringe as follows:

The aqueous solution comprises of glucose, amino acids, electrolytes, minerals and trace elements (if peditrace is added) and the lipid emulsion contains both fat- and water-soluble vitamins (if provided as an outsourced syringe).

Most compounded PN is unlicensed and supplied by companies who hold a 'manufacturing specials (MS) license'. PN is classed as unlicensed if it is a ‘scratch’ bag or a standard licenced bag with additions e.g., vitamins/minerals. All the stock neonatal PN preparations at FHFT are unlicensed and require a ‘quality check’ when dispensed in pharmacy.

PN formulations used at FHFT are provided by pharmacy via an external licensed aseptic unit (ITH Pharma).

See appendix for ITH Pharma product specifications for each aqueous infusion bag and lipid syringe. Product specifications list the major constituents per product.

Nutritional breakdown of PN Glucose 10% with electrolytes (trace elements not listed):

PN VOLUME PRESCRIBING INFORMATION

Day 1 (0-24 hours of life): 60mL/kg/day aqueous solution + 5mL/kg/day lipid

Day 2 (24-48 hours of life): 90mL/kg/day aqueous solution + 10mL/kg/day lipid

Day 3 (48-72 hours of life): 120mL/kg/day aqueous solution + 17mL/kg/day lipid

Day 4 (72 hours of life onwards): 150mL/kg/day aqueous solution + 17mL/kg/day lipid

The volume of lipid is ‘extra’ to total fluid allowance

When baby is taking 90ml/kg/day or more of milk (usually day 4 of standard feeding regime as per Milk Feeding in Preterm Infants guideline) please half the lipid infusion rate to 8.5ml/kg/day.

Aqueous infusion bags

• Day 1 (0-24 hours of life) PN should be prescribed as glucose 10% electrolyte-free

• Day 2 (24-48 hours of life) PN should be prescribed as glucose 10% with electrolytes

• Day 3 (48 hours of life) onwards PN should be prescribed as glucose 10% with electrolytes and peditrace

Glucose 10% with electrolytes and peditrace should be ordered by the ward pharmacist by 10am Monday to Friday. If not available, continue with glucose 10% with electrolytes and discuss with the ward pharmacist as soon as possible.

Intralipid bags/ lipid syringes

• Lipid syringes should be ordered by the ward pharmacist by 10am Monday to Friday

• If lipid syringes are not available, the lipid emulsion can be provided from intralipid 20% bags which are ward stock. The required volume should be drawn up into a 30mL syringe by nurses for administration via a syringe infusion pump. Only one withdrawal should be made from the intralipid 20% bag and then discarded.

For adequate nutrition provision, it is important that the lipid always runs alongside the aqueous solution.

Scratch bag PN

Scratch PN may also be appropriate where infants have electrolyte requirements that cannot be met with stock PN. However, this should only be used in exceptional circumstances

If appropriate, requests must be made to the pharmacist before 10am Monday to Friday.

It should be ordered and prescribed in conjunction with the consultant, ward pharmacist and dietitian.

Stability of PN

PN stability for standard and bespoke bags is provided by ITH Pharma prior to placing the order.

For scratch PN, the current portal for ordering includes a matrix approach, where all starting materials (amino acid and lipid solutions) are within pre-defined limits in order to assure stability.

ITH Pharma will offer warnings where combinations of ingredients show formulation instability.

Orders will not be accepted on the ITH Pharma portal unless PN meets stability requirements.

The responsibility for the stability of scratch bag PN, that is purchased from ITH Pharma, lies with the pharmacist responsible for prescription verification and ordering of the PN.

The pharmacist will advise the doctor and dietitian of any changes that need to be made to the prescription, due to stability issues and the prescription will be amended, signed and verified accordingly.

Step-by-step guide for Epic prescribing:

1. Order search ‘TPN’

   

2. Select neonatal => standard and you will be presented with the below options.

You will be prompted to select a choice of lipid.

Please check with the nurses what is available before proceeding and select accordingly.

3. When prescribing ensure the following boxes are completed accurately:

• Dose (= total daily fluid allowance for infant)

• Weight (always working with the biggest weight)

• Prescription start time (check with the nurses)

• Duration (will always be 24 hours)

• Infusion site (central or peripheral)

4. Prescribe the lipid syringe/ intralipid bag in the same way.

5. Doctor/ independent prescribing pharmacist should sign the new orders for the nurse to administer. Note that the orders will be linked together automatically using the TPN panel.

Light protection

Both the aqueous bag and lipid syringe must always be protected from UV light (during storage and administration) to prevent photodegradation and oxidation of PN components.

During PN administration, the PN bag and syringe must be covered by a light-protective bag and amber infusion lines must be used to connect the PN bags through the infusion pumps to the IV access device.

Filter

PN must be administered via a filter to reduce the risk of harmful events that can occur if PN is contaminated with particulate matter, microorganisms or precipitates.

• The aqueous solution must be administered via a 0.2-micron filter

• The lipid emulsion must be administered via a 1.2 – 1.5-micron filter

• The use of filters integrated into giving sets is preferable to separate filters, where these are available.

• PN filters and administration sets should be changed with each PN change.

IV access

Use a central venous catheter to administer neonatal PN.

Only consider using peripheral venous access if:

• It would avoid a delay in starting PN

• It would avoid interruption in PN delivery

• Central venous access is impractical

• Glucose concentration of the PN is ≤10%

Consider requesting surgical insertion of a central venous catheter if:

• Long term PN in anticipated

• Non-surgical insertion is not possible

All stock neonatal PN formulations (aqueous bags and lipid bags/ syringes) stocked at FHFT are safe for both peripheral and central administration.

Infusion duration

The total duration of each PN infusion (aqueous and lipid) should NOT exceed 24 hours.

Safety & error prevention

PN infusion set up, attachment of the giving set and connection to the infant must be performed using full aseptic non-touch technique.

Every time a line is manipulated there is a risk of line related infection. This risk is SIGNIFICANTLY INCREASED by reconnecting PN lines. If PN is disconnected, discard the bag.

All PN must be checked against the prescription and fluid requirements by two registered nurses, one of whom must be qualified in the neonatal speciality. Both nurses must remain present until the PN infusions are set up in infusion devices and lines are connected to the infant.

Safety checks must be undertaken at the point of administration of PN for:

• PN type matches the prescription

• Date of infusion matches the prescription

• Rate of infusion matches the prescription

• The PN has not expired, and will not expire during the planned infusion time

• The appearance of the PN solutions (for discolouration or precipitation)

Particular attention must be paid to ensure that the aqueous and lipid infusions are being delivered via the correct infusion pump and at the correct rate.

Flow rates of aqueous and lipid infusions are controlled by separate infusion pumps. There have been documented instances where the rates/pumps have been confused resulting in significant over-infusion of lipids, and under infusion of aqueous PN.

To prevent this, set the infusion pumps on the same pole-mount, with the top/higher pump always assigned to deliver aqueous PN at the higher rate and the bottom/lower pump assigned to deliver the lipid PN at the lower rate.

Infants receiving PN require monitoring of various parameters to assess effectiveness and prevent or detect complications. The recommended parameters and frequency of monitoring are summarised in the table below.

For laboratory investigations, use minimum blood volumes and co-ordinate the timing of blood tests to minimise blood samples.

* These parameters may require more frequent monitoring based on previous abnormal results or the infant’s clinical condition.

For infants on long-term PN, measure trace elements (copper, zinc, selenium, manganese), iron status & vitamins A, D & E on day 28 and then monthly for the duration of PN. Blood samples for monitoring of trace element levels should not be taken while the infant has active infection or inflammation, the results will not be a true reflection of trace element status. Some trace elements are acute phase reactants, and the impact of the acute phase response on their serum levels is described below.

As enteral feeds increase, the aqueous infusion rates should be weaned to maintain the same total fluid intake. Lipid rates are maintained at the same rate throughout the weaning process.

Once enteral feeds are providing between 120- 150mL/kg/day of the total fluid intake, PN may be stopped. The decision to stop PN should be based on assessment of the individual infant’s nutritional status, fluid balance and growth parameters.

Glucose Control

Hyperglycaemia and (less commonly) hypoglycaemia may occur while an infant is receiving PN.

Follow the neonatal unit guidelines for the management of either, but also consider the following:

• For infants with hyperglycaemia while receiving PN, it may be beneficial for growth to use insulin to control the blood glucose levels rather than reducing the PN delivery.

• For infants with hypoglycaemia, confirm no mechanical problems are impeding the delivery of the aqueous PN. If hypoglycaemia persists, requiring additional high-concentration glucose infusions alongside PN, additional investigations may be warranted to identify or rule out underlying causes.

Infection

Catheter-related bloodstream infections (CRBSI) are a recognised risk and complication of PN administration. Use aseptic non-touch technique when handling central lines and avoid co-infusion of medications to minimise risk of CRBSI.

If a change in clinical or biochemical status raises concern over a potential CRBSI, take paired blood cultures simultaneously from both the central venous catheter and a peripheral vein (or separate venous access) before starting antibiotic therapy.

Liver Disease

Intestinal Failure-Associated Liver Disease (IFALD) is a serious complication of prolonged PN use. Additional risk factors for IFLAD include prematurity, jejunal atresia, necrotising enterocolitis (which may lead to short gut and/or dysmotility), intestinal failure, intolerance of enteral intake, sepsis and surgical conditions such as gastroschisis.

Infants on the neonatal unit with IFALD should be discussed with gastroenterology at the tertiary unit, who will advise on management strategies. These may include additional medication, a reduction in lipid dose or reducing the PN infusion time (‘cyclical PN’).

Elevated Triglycerides

Incremental introduction of lipid dose may reduce the risks of hypertriglyceridemia; however close monitoring is still required. If hypertriglyceridemia is left untreated infants could potentially develop complications, such as pancreatitis and lipid pneumonitis, and neurological changes, such as kernicterus.

Monitoring should start from Day 3 of PN.

• Target serum triglyceride level: ≤2.8mmol/L

• If serum triglyceride level is between 2.9 mmol/L and 3.9 mmol/L, then reduce infusion rate of lipid to previous infusion rate and recheck in 48 hours

• On rechecking, if serum triglyceride level has fallen back to ≤2.8mmol/L, then increase infusion rate of lipid again to the next rate up and resume usual monitoring

• If serum triglyceride level is ≥4 mmol/L, then reduce infusion rate of lipid to 5mL/kg/day AND seek tertiary advice 

Metabolic Bone Disease

Prolonged PN use is a risk factor for the development of metabolic bone disease of prematurity, due to the inability to provide calcium and phosphate in sufficient quantities through PN. Refer to the tertiary unit specific Metabolic Bone Disease guideline for advice on screening, monitoring and management of metabolic bone disease.

Glucose 10% electrolyte-free

Glucose 10% with electrolytes

Glucose 10% with electrolytes and peditrace

Lipid syringe