What's New?- August 2017

This pathway has been produced as part of the Infant Feeding pathway to ensure that support is provided to enable babies to be fed safely/appropriately.

Cow's Milk Allergy Care Pathway Overview

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Symptoms start when the infant is introduced to infant formula containing cow’s milk in their diet or sometimes if the mother is breastfeeding and having dairy foods in her diet.

Cow's Milk Protein Allergy (CMPA) affects around 5% of children under 1 year in the UK with:

  • Persistent symptoms affecting different organ systems
  • Poorly responding eczema, gastro-oesophageal reflux disease (GORD), chronic gastro symptoms (including constipation)
  • Faltering growth in addition to symptoms outlined below

(Symptoms differ if the allergy is Immunoglobin E (IgE)-mediated or non-IgE mediated).

  • Speed of onset of symptoms- acute within 2 hours after ingestion
  • Skin - erythema, itch, acute urticarial acute angio oedema
  • Gastro - oral itch, nausea, colicky pain, vomiting, diarrhoea
  • Respiratory - lower (cough, wheeze, shortness of breath), upper (nasal itch, sneezing, rhinorrhoea or congestion)
  • Other - other allergies or anaphylaxis

  • Speed of onset of symptoms - 48 hours to a week after ingestion
  • Skin - eczema
  • Gastro - reflux, loose frequent stool, blood/mucus, abdo pain, infantile colic, food refusal, constipation, perianal redness, pallor, poor growth
  • Respiratory - lower (cough, wheeze, shortness of breath)
Red Flags
  • Tiredness or lethargy
  • Fevers
  • Severe vomiting or diarrhoea,
  • Not tolerating any feeds
  • Weight loss
  • Blood in the stools
Severe IgE Cow's Milk Protein Allergy/Immediate reaction with severe respiratory and/or cyclic vomiting syndrome (CVS) signs and symptoms (Rarely a severe gastrointestinal presentation). Admit Direct to Accident & Emergency
Differential Diagnosis

  • Offer reassurance and advise parents and carers that in well infants, effortless regurgitation of feeds:
  • Is very common (it affects at least 40% of infants).
  • Usually begins before the infant is 8 weeks old.
  • May be frequent (5% of those affected have 6 or more episodes each day).
  • Usually becomes less frequent with time (it resolves in 90% of affected infants before they are 1 year of age).
  • Treatment or further investigation is not normally required.

Review infant or child if:

  • Regurgitation becomes persistently projectile — admission is required.
  • There is bile-stained vomiting or haematemesis — admission is required.
  • There are new concerns, such as signs of marked distress, feeding difficulties, or faltering growth — suggests a diagnosis of gastro-oesophageal reflux
  • There is persistent, frequent regurgitation beyond the first year of life

See GORD pathway (to be linked when published)

See Lactose Intolerance pathway (to be linked when published)

See Faltering Growth pathway (to be linked when published)
Initial Primary Care Assessment


NICE recommends further investigation with a specific IgE antibody blood test or skin prick test.

Trial elimination for for weeks of the suspected allergen is advised.  After a four week elimination confirmation is required by challenging with cow's milk protein (CMP) via standard formula milk prior to longer term treatment/prescribing.  Most infants with cow's milk protien allergy (CMPA) develop symptoms within one week of introduction of CMP-based formula.
Initial Primary Care Management

Breast milk is the ideal choice for most infants with CMPA. Mothers should be encouraged and supported to continue breastfeeding:

  • If symptoms persist in the exclusively breast-fed infant, a maternal “dairy-free” diet is indicated for a minimum trial of 2 weeks.
  • Breastfeeding mothers on a cow’s-milk-free diet may require supplementation with 1000mg calcium per day.

If formula fed:

  • Extensively hydrolysed formulae (EHF) are the first choice, unless the infant has a history of anaphylactic symptoms.
  •  10% of CMPA children are intolerant of hydrolysed formula and may require an amino acid formula.

Extensively hydrolysed formulae (EHF)

Product Presentation Price Cost/100g Cost/100kcals
Similac Alimentum 400g tin £9.10 £2.28 £0.43
Nutramigen Lipil 400g tin £10.66 £2.67 £0.57


If intolerant to hydrolysed formula and require amino acid formula

Product Presentation Price Cost/100g Cost/100kcals
Nutramigen AA 400g tin £26.27 £6.57 £1.32

When any infant formula is prescribed the guide below should be used:

Age Number of tins for 28 days
Under 6 months 13 x 400g tins or 6 x 900g tins
6-12 months 7-13 x 400g tins or 3-6 x 900g tins
Over 12 months 7 x 400g tins or 3 x 900g tins
  • Under 6 month infants will be exclusively formula fed so require greater quantities (150ml/kg/day)
  • Infants 6-12 months will be also taking some solids so less needed


  • Promote,encourage and support breastfeeding.
  • Check any formula prescribed is appropriate for the age of the infant.
  • Check the amount of formula prescribed is appropriate for the age of the infant.
  • Review any prescription where the child is over two years old, the formula has been prescribed for more than one year, or greater amounts of formula are being prescribed than would be expected.
  • Review the prescription if the patient is prescribed a formula for CMPA but able to eat any of the following foods – cow’s milk, cheese, yogurt, ice cream, custard, chocolate, cakes, cream, butter, margarine, ghee.
  • Prescribe only 1 or 2 tins/bottles initially until compliance/tolerance is established.
  • Remind parents to follow the advice given by the formula manufacturer regarding safe storage of the feed once mixed or opened.
  • Refer where appropriate to secondary or specialist care.
  • Refer where appropriate to the paediatric dietitians.
  • Seek prescribing advice if needed in primary care from the CCG Medicines Optimisation Team.
  • Seek prescribing advice if needed in secondary care from the local Hospital Medicines Information Centre.


  • Add infant formulae to the repeat prescribing template in primary care, unless a review process is established to ensure the correct product and quantity is prescribed for the age of the infant.
  • Prescribe lactose free formulae (SMA LF®, Enfamil O-Lac®) for infants with CMPA.
  • Routinely prescribe soya formula (Infasoy®, SMA Wysoy®) for those with CMPA or secondary lactose intolerance. It should not be prescribed at all in those under 6 months due to high phytoestrogen content.
  • Suggest milk and formulae made from goat’s milk, sheep’s milk or mammalian milks for those with CMPA or secondary lactose intolerance.
  • Suggest rice milk for those under 5 years due to high arsenic content.
  • Prescribe Nutriprem 2 Liquid® or SMA Gold Prem 2 Liquid® unless there is a clinical need.
  • Prescribe thickening formulae (SMA Staydown®, Enfamil AR®) with separate thickeners or in conjunction with medication such as antacids, ranitidine, or proton pump inhibitors, since the formulae need stomach acids to thicken and reduce reflux.
  • Suggest Infant Gaviscon® more than 6 times in 24 hours or where the infant has diarrhoea or a fever, due to its sodium content.
  • Prescribe low lactose/lactose free formulae in children with secondary lactose intolerance over 1 year who previously tolerated cow’s milk, since they can use lactose free products (e.g. Lactofree®) from supermarkets.

  • Encourage breast feeding whenever possible
  • Review prescription if child more than two years old, the formula has been prescribed for more than a year, or greater amounts being prescribed than expected
  • Review prescription for CMPA if can tolerate any of – cow’s milk, cheese, yogurt, ice cream, custard, chocolate cakes, cream, butter, margarine, ghee
  • Prescribe 1-2 tins initially until compliance/tolerance established
  • Do not use lactose free milks for CMPA
  • Do not use soya milk for CMPA or secondary lactose intolerance
  • Do not suggest rice milk, goat, milk, sheep milk 
  • Avoid using thicken formulas with ranitidine/PPI
  • Avoid lactose free formula in secondary lactose intolerance if more than 1 years old and previously tolerated cow’s milk as they are over-the-counter e.g. ‘Lactofree’ milk (www.lactofree.co.uk)

  1. Soya formula (Infasoy®, SMA Wysoy®) should not routinely be used for patients with CMPA. It should not be used at all for those under 6 months due to high phyto-oestrogen content. It should only be advised in patients over 6 months who do not tolerate first line EHF since there is a risk that infants with CMPA may also develop allergy to soya. It is more likely that children will tolerate soya formula from 1 year. Parents should be advised to purchase soya formula as it is a similar cost to cow’s milk formula and readily available. From 2 years supermarket calcium enriched soya or oat milk may be suitable as an alternative. Alpro® Junior 1+ soya milk may be suitable from 1 year. The paediatric dietician will advise on suitable over-the-counter products for appropriate ages.
  2. EHF and AAF have an unpleasant taste and smell, which is better tolerated by younger patients. Unless there is anaphylaxis, advise parents to introduce the new formula gradually by mixing with the usual formula in increasing quantities until the transition is complete. Serving in a closed cup or bottle or with a straw (depending on age) may improve tolerance. In some cases the formula will need to be flavoured e.g. with the minimum amount of milkshake flavouring. Care should be taken and ingredients checked in those with multiple allergies.
  3. Prescribe 1 or 2 tins initially until compliance/tolerance is established to avoid waste.
  4. Rice milk is not suitable for children under 5 years due to its arsenic content.
  5. Outgrowing CMPA – 60-75% of children outgrow CMPA by 2 years of age, rising to 85-90% of children at 3 years of age.
  6. Calcium supplementation may be needed for infants depending on volume and type of formula taken. Breast-feeding mothers on a milk free diet may also need a calcium supplement. The dietician will advise
  7. Lactose free formulae (SMA LF®, Enfamil O-Lac with LIPIL®) are not suitable for those with CMPA.
  8. Goat, sheep, and other mammalian milks are also not suitable for those with CMPA.
When to Refer

Most infants with CMPA can be managed in primary care until weaned.

Referral to a paediatric dietitian should be made prior to weaning for all infants who will require a cow’s milk free diet. Breastfeeding mothers following a milk free diet should be referred to the paediatric dietitian who will advise on both the mother’s and the child’s diet.

Refer to secondary or specialist care if any of the following apply:

  • Faltering growth with one or more gastrointestinal symptoms.
  • Acute systemic reactions or severe delayed reactions.
  • Significant atopic eczema where multiple or cross-reactive food allergies are suspected by the parent or carer
  • Possible multiple food allergies.
  • Persisting parental suspicion of food allergy despite a lack of supporting history (especially where symptoms are difficult or perplexing).
Ongoing Primary Care

Review and discontinuation of treatment and challenges with cow’s milk

  • Quantities of formula required will change with age -and/or refer to the most recent correspondence from the paediatric dietitian.
  • Avoid adding to the repeat template unless a review process is established.
  • Challenging with cow’s milk 
    • Trial of reintroduction at home after 6 months of treatment unless history of severe reaction.
    • Children with proven IgE mediated CMPA are advised to be followed up by an allergy specialist (repeat IgE blood tests or skin prick testing will be required)
    • Refer to NICE guidelines on which children should be challenged with cow’s milk in secondary care setting.
  • Prescriptions should be stopped when the child has outgrown the allergy

  • Is the patient over 2 years of age?
  • Has the formula been prescribed for more than 1 year?
  • Is the patient prescribed more than the suggested quantities of formula according to their age?
  • Is the patient prescribed a formula for CMPA but able to eat any of the following foods – cow’s milk, cheese, yogurt, ice-cream, custard, chocolate, cakes, cream, butter, margarine, ghee?

Children with multiple or severe allergies may require prescriptions beyond 2 years. This should always be at the suggestion of the paediatric dietitian. 


Patient Resources

Please see the Community Resources and Patient & Carer Information & Leaflets sections.

Resources for Professionals

National Standards

Please see the National and NICE Guidance section

There are no  significant variations from the national standards in this pathway

Other Online Resources


Pathway Leads





Sue Maxwell Infant Feeding Specialist Midwife

Gloucestershire Hospitals Foundation Trust

Dr Russell Peek Paediatrician  Gloucestershire Hospitals Foundation Trust Russell.Peek@nhs.net
Dawn Morrall Assistant Director of Maternity & Fertility Services/Lead for Midwifery Led Care Supervisor of Midwives Gloucestershire Hospitals Foundation Trust Dawn.Morrall@glos.nhs.uk
Emma Cronin-Preece Health Visitor Infant Feeding Specialist Gloucestershire Care Services emma.cronin-preece@glos-care.nhs.uk

Dr Jeremy Welch


Gloucestershire Clinical Commissioning Group


Helen Ford

Senior Commissioning Manager
Children, Young People & Maternity Commissioning team

Gloucestershire Clinical Commissioning Group


Vicky Townsend Assistant Commissioning Manager, Children,Young People and Maternity Commissioning Team Gloucestershire Clinical Commissioning Group vicky.townsend@nhs.net

Reason for Pathway Selection

This pathway has been produced as part of the Infant Feeding pathway to ensure women get the support they need to feed their babies.

Completion Date

August 2017

Review Date

July 2018