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Paediatric reflux disease guidance
The text below aims to give a brief introduction to paediatric gastroeosophageal reflux; it is largely based on guidance contained within NICE Guideline NG1: Gastro-oesophageal reflux disease in children and young people: diagnosis and management (published January 2015). The text has been developed in collaboration with local specialist opinion.
Gastroeosophageal reflux is the effortless retrograde passage of small volumes of gastric contents into the oesophagus or oropharynx. This is a physiological event which occurs in virtually everyone, most frequently after eating. In many infants, gastroeosophageal reflux is associated with a tendency to 'overt regurgitation' – the visible regurgitation of feeds. In contrast, gastro-oesophageal reflux disease (GORD) occurs when the effect leads to symptoms severe enough to merit medical treatment, for example discomfort or pain, or to gastro-oesophageal reflux-associated complications such as oesophagitis or pulmonary aspiration.
Regurgitation of food and fluids is very common in infants and is usually benign. It does not usually need any investigation or treatment and is managed by advising and reassuring parents and carers. In a small proportion of infants it may be associated with signs of distress or may lead to certain recognised complications that need clinical management (GORD).
Regurgitation usually begins before the infant is 8 weeks old, and usually resolves between 6 and 12 months. Some symptoms of a non-IgE-mediated cow's milk protein allergy can be similar to the symptoms of GORD, especially in infants with atopic symptoms, signs and/or a family history. Cow's milk protein allergy should be considered if a child with gastroeosophageal reflux shows any sign of back arching, faltering growth, excessive crying/screaming and constipation/liquid stool, or eczema. If suspected, refer to 'Formulas for the treatment of cow's milk allergy' and NICE Clinical Guideline CG116: Food allergy in under 19s: assessment and diagnosis (February 2011).
When reassuring parents and carers about regurgitation, advise them that they should return for review if any of the following occur:
- the regurgitation becomes persistently projectile
- there is bile-stained vomiting or haematemesis
- there are new concerns, such as signs of marked distress, feeding difficulties or faltering growth
- there is persistent, frequent regurgitation beyond the first year of life.
Infants and children are not investigated or treated for gastro‑oesophageal reflux if they have no visible regurgitation and only 1 associated symptom. Excessive gastro‑oesophageal reflux disease can cause symptoms which include poor weight gain, refusal to feed, pain, apnoea and cough/aspiration. These symptoms are unusual and more common in infants and children with underlying neurological disease.
Where infants and children have symptoms over and above simple regurgitation, a secondary care opinion may be considered.
Initial management of regurgitation in infants
Advise on simple measures and reassure parents that although distasteful, the condition is not harmful and will improve. Positioning (upright) after feeds may help however do not use positional management to treat in sleeping infants. In line with NICE advice, infants should be placed on their back when sleeping.
In breast-fed infants with frequent regurgitation associated with marked distress that continues despite a breastfeeding assessment and advice, consider alginate therapy for a trial period of 1–2 weeks. If the alginate therapy is successful continue with it, but try stopping it at intervals to see if the infant has recovered. Parents and carers should be advised regarding the challenges associated with administering Gaviscon Infant to breast fed infants; guidance relating to the preparation and administration of Gaviscon Infant may be found here.
In formula-fed infants with frequent regurgitation associated with marked distress, use the following stepped-care approach:
- Review the feeding history, then
- Reduce the feed volumes (to maximum 150ml/kg/day) only if excessive for the infant's weight, then
- Offer a trial of smaller, more frequent feeds (while maintaining an appropriate total daily amount of milk) unless the feeds are already small and frequent, then
- Offer a trial of thickened formula (for example, containing rice starch, corn starch, locust bean gum or carob bean gum). These can be purchased at a similar cost to standard formula.
- Note that if parents are happy with the current formula, addition of a thickener may be considered before switching to a pre-thickened product.
If the stepped-care approach is unsuccessful, stop the thickened formula and offer alginate therapy for a trial period of 1–2 weeks. If the alginate therapy is successful continue with it, but try stopping it at intervals to see if the infant has recovered.
Pharmacological treatment of GORD
Ranitidine: The European Medicines Agency has recommended a precautionary suspension of the licences for all ranitidine medicines (30 April 2020). See section 1.3.1 H2-receptor antagonists for further information
Medication is only of variable effectiveness in reducing vomiting. Gaviscon Infant is safe and can be tried first line; it should not be used with other preparations containing thickening agents (thickened feeds or added thickeners) due to the risk of bezoar formation.
Do not offer acid-suppressing drugs, such as proton pump inhibitors (PPIs) or H2 receptor antagonists (H2RAs), to treat overt regurgitation in infants and children occurring as an isolated symptom.
Consider a 4-week trial of a PPI or H2RA (not ranitidine, see above) for those who are unable to tell you about their symptoms (for example, infants and young children, and those with a neurodisability associated with expressive communication difficulties) who have overt regurgitation with 1 or more of the following:
- Unexplained feeding difficulties (for example, refusing feeds, gagging or choking)
- Distressed behaviour
- Faltering growth
Children with neurological disorders/ disability may be receiving treatment via a gastrostomy. Specialist advice should be sought regarding change in formulations which may be needed for administration via this route in order to avoid blocking the tube.
Consider a 4-week trial of a PPI or H2RA (not ranitidine, see above) for children and young people with persistent heartburn, retrosternal or epigastric pain.
Assess the response to the 4-week trial of the PPI or H2RA, and consider referral to a specialist for possible endoscopy if the symptoms do not resolve or they recur after stopping the treatment.
When choosing between PPIs and H2RAs, take into account the availability and licensing of medications, and the preference of the parent (or carer), child or young person. The European Medicines Agency has recommended a precautionary suspension of the licences for all ranitidine medicines (30 April 2020). See section 1.3.1 H2-receptor antagonists for further information.
The use of PPIs and H2RAs has been suggested to be a risk factor for the development of C. difficile-associated disease. All acid-blocking medicines may reduce the absorption of vitamin B12 due to hypo- or achlorhydria. Monitoring may be considered in patients with reduced body stores or risk factors for reduced dietary vitamin B12 absorption on long-term therapy (paediatric patients who remain on PPIs for more than 2 years).
Please see section 1.3 Antisecretory drugs and mucosal protectants
Do not offer metoclopramide, domperidone or erythromycin to treat gastroeosophageal reflux without seeking specialist advice and taking into account their potential to cause adverse events.
MHRA Drug Safety Update (December 2014): Metoclopramide: risk of neurological adverse effects. Metoclopramide is contraindicated in children under 1 year of age and should only be prescribed for short term use (up to five days).
MHRA Drug Safety Update (December 2019): Domperidone for nausea and vomiting: lack of efficacy in children; reminder of contraindications in adults and adolescents - includes prescribing for children under 12 years of age for gastrokinetic effects in conditions over than nausea and vomiting
MHRA Drug Safety Update (December 2020): Erythromycin: update on known risk of infantile hypertrophic pyloric stenosis
Note that some liquid preparations contain significant amounts of alcohol acting as a solvent, the intake of which must be minimised in the paediatric population. Please consult individual product literature for excipient information (note that liquid PPIs are non-formulary items).
