Gastro-oesophageal reflux disease in children: NICE guidance



## Diagnosing and investigating gastro-oesophageal reflux disease
- Recognise regurgitation of feeds as a common and normal occurrence in infants and that it: -Is caused by gastro-oesophageal reflux-a normal physiological process in infancy (the box outlines the definitions of gastro-oesophageal reflux and GORD used in this guideline) -Does not usually need any investigation or treatment -Is managed by advising and reassuring parents and carers.
[Based on high, moderate, and low quality evidence from observational studies and on the experience and opinion of the Guideline Development Group .]
- Be aware that in a small proportion of infants, gastro-oesophageal reflux may be associated with signs of distress or may lead to certain recognised complications that need clinical management. This is known as gastro-oesophageal reflux disease. [Based on the experience and opinion of the - Give advice about gastro-oesophageal reflux, and reassure parents and carers that in well infants effortless regurgitation of feeds: -Is common (affects at least 40% of infants) -Usually begins before the infant is 8 weeks old -May be frequent (5% of those affected have six or more episodes a day)
The bottom line - Frequent, effortless regurgitation of feeds is common during early infancy. Although worrying for parents, it usually resolves by the age of 1 year and usually does not need investigation or specific treatment. Effective management requires detailed, repeated, and confident reassurance
- For infants and children who present with regurgitation or vomiting, actively look out for "red flags" (such as projectile vomiting, bile stained vomiting, haematemesis, blood in stool, abdominal distension, or systemic features) that may suggest more serious conditions
- Consider simple cheap interventions, such as minor feed modifications or thickening agents, when possible and avoid acid suppressing drugs in isolated overt regurgitation
- Do not use upper gastrointestinal contrast radiology to diagnose or assess the severity of gastro-oesophageal reflux disease. This test is indicated for other reasons such as dysphagia or unexplained bile stained vomiting

## Definitions used in the guideline
Gastro-oesophageal reflux: The passage of gastric contents into the oesophagus. It is a common physiological event that can happen at all ages from infancy to old age and is often asymptomatic. It is more common after feeds or meals. In many infants it is associated with a tendency to "overt regurgitation"-the visible regurgitation of feeds.
Gastro-oesophageal reflux disease: Gastro-oesophageal reflux that causes symptoms (for example, discomfort or pain) severe enough to merit medical treatment or that has associated complications (such as oesophagitis or pulmonary aspiration). In adults, the term is often used more narrowly, referring specifically to reflux oesophagitis.

## Marked distress:
There is limited evidence, and no objective or widely accepted clinical definition, for what constitutes marked distress in infants and children who cannot adequately communicate their sensory emotions. In this guideline, marked distress refers to an outward demonstration of pain or unhappiness outside of that considered to be the normal range by an appropriately trained competent healthcare professional on the basis of a thorough assessment. This assessment should include a careful analysis of the description offered by the parents or carers of the individual child.
[Based on high, moderate, and low quality evidence from observational studies.]
- When reassuring parents and carers about regurgitation, advise them that they should return for review if any of the following occur: -Regurgitation becomes persistently projectile -There is bile stained (green or yellow-green) vomiting or haematemesis (blood in vomit) -There are new concerns, such as signs of marked distress (box), feeding difficulties, or faltering growth -There is persistent frequent regurgitation beyond the first year of life.
[Based on moderate and low quality evidence from observational studies and on the experience and opinion of the GDG.]
- In infants, children, and young people with vomiting or regurgitation, look out for "red flag" symptoms (table) that may suggest disorders other than gastro-oesophageal reflux. - Arrange an urgent specialist hospital assessment to take place on the same day for infants younger than 2 months with progressively worsening or forceful vomiting of feeds to assess them for possible hypertrophic pyloric stenosis.
[Based on the experience and opinion of the GDG.]
- For recommendations relating to the indications for endoscopy and oesophageal pH study or impedance monitoring, see the further information box.
- Investigate the possibility of a urinary tract infection in infants with regurgitation if there is: -Faltering growth -Late onset of regurgitation (after age 8 weeks)
-Frequent regurgitation and marked distress.
[Based on the experience and opinion of the Initial management of gastro-oesophageal reflux and GORD - For further recommendations on enteral tube feeding and surgery see the further information box.

## Overcoming barriers
It can be difficult to persuade families that distressing and disabling symptoms (such as frequent and severe vomiting in thriving infants) will almost certainly improve with time but can be helped by relatively minor interventions, rather than referral for unnecessary tests or the use of drugs with no confirmed effect. This guideline offers clear direction as to when and how families can be appropriately reassured and provides links to downloadable information for parents. However, for different clinical presentations or evolving symptoms, especially potentially serious red flag presentations, the guideline recommends actions that are clearly necessary by way of investigation, treatment, and referral.

## Further information on the guidance
A gastro-oesophageal reflux disease (GORD) pathway that visually represents all of the recommendations is available on the National Institute for Health and Care Excellence (NICE) pathways website (http://pathways.nice.org.uk/pathways/dyspepsia-and-gastro-oesophageal-reflux-disease). NICE pathways are for health and social care professionals, public health experts, commissioners or providers of health and social care services, and members of the public. Audit and costing tools to support implementation are also available (www.nice.org.uk/guidance/NG1/resources). Parents, children, and young people can also be directed to corresponding NICE information for the public (www.nice.org.uk/guidance/NG1/informationforpublic).

# Methods
This guidance was developed by the National Collaborating Centre for Women's and Children's Health in accordance with NICE guideline development methods (www.nice.org.uk/guidelinesmanual). The Guideline Development Group (GDG) comprised two paediatric gastroenterologists (including the chair); a paediatrician; a neonatologist; a consultant in paediatric neurodisability; a paediatric surgeon; two general practitioners; an advanced paediatric nurse practitioner; a paediatric dietitian; a health visitor; lay members with experience of caring for such infants, children, or young people; and experts in guideline methodology. There was also a pharmacist as an "invited expert." The GDG identified relevant clinical questions, collected and appraised clinical evidence, and where possible evaluated the cost effectiveness of proposed interventions. The draft guideline underwent a public consultation and a validation process in which stakeholder organisations were invited to comment; all comments were considered when producing the final version of the guideline.
NICE has produced four different versions of the guideline: a full version containing all the evidence, the process undertaken to develop the recommendations, and all the recommendations; a version containing a list of all the recommendations, known as the "NICE guideline"; a version for patients and the public (www.nice.org. uk/guidance/NG1/informationforpublic); and a web version of the care pathway (the "NICE pathway"). All these versions are available from the NICE website (www. nice.org.uk/guidance/NG1). Implementation tools will also be available from the NICE website. The guideline will be reviewed for update in two years' time as part of the NICE guideline development programme.

# Future research
A prospective cohort study to evaluate the diagnostic accuracy of symptoms associated with GORD in infants, children, and young people with complex severe neurodisability to detect GORD (diagnosed as reflux oesophagitis identified by endoscopy and oesophageal pH monitoring).
A randomised controlled trial in formula fed infants with suspected GORD that compares the effects of an extensively hydrolysed formula feed versus a placebo milk substitute on clinical symptoms and the results of objective measurements (endoscopy and oesophageal pH monitoring).
A prospective evaluation of objective symptom profiles, oesophageal pH monitoring, and upper gastrointestinal endoscopy before and after fundoplication surgery in children with GORD.

## Further recommendations
Gastrointestinal contrast study [Based on high, moderate, and low quality evidence from observational studies and on the experience and opinion of the GDG.]
- Consider performing an oesophageal pH study without impedance monitoring in infants, children, and young people if, using clinical judgment, this is thought necessary to ensure effective acid suppression. [Based on the experience and opinion of the Enteral tube feeding for GORD
- Consider enteral tube feeding to promote weight gain in infants and children with overt regurgitation and faltering growth only if: -Other explanations for poor weight gain have been explored or -Recommended feeding and medical management of overt regurgitation is unsuccessful. - Before starting enteral tube feeding for infants and children with faltering growth associated with overt regurgitation, agree in advance: -A specific individualised nutrition plan -A strategy to reduce enteral tube feeding as soon as possible -An exit strategy, if appropriate, to stop enteral tube feeding as soon as possible.
[Based on the experience and opinion of the GDG.]
- In infants and children receiving enteral tube feeding for faltering growth associated with overt regurgitation: -Provide oral stimulation, continuing oral feeding as tolerated -Follow the nutrition plan, ensuring that the intended target weight is achieved and that appropriate weight gain is sustained -Reduce and stop enteral tube feeding as soon as possible.
[Based on the experience and opinion of the GDG.]
- Consider jejunal feeding for infants, children, and young people: -Who need enteral tube feeding but who cannot tolerate intragastric feeds because of regurgitation or -If reflux related pulmonary aspiration is a concern.
[Based on the experience and opinion of the Investigations before surgery Haematemesis (blood in vomit) with the exception of obviously swallowed blood (for example, after a nose bleed or ingested blood from a cracked nipple in breastfed infants) Urine microbiology investigation 2 Late onset suggests a cause other than reflux, such as a urinary tract infection (also see National Institute for Health and Care Excellence (NICE) clinical guideline on urinary tract infection in children 2 ). Persistence suggests an alternative diagnosis Onset of regurgitation or vomiting (or both) after age 6 months or persisting after age 1 year Stool microbiological investigation and specialist referral 3 May suggest a variety of conditions, including bacterial gastroenteritis, infant cows' milk protein allergy (also see NICE clinical guideline on food allergy in children and young people 3 ), or an acute surgical condition

## Suggested action* possible diagnostic implication symptom or sign
Specialist referral May suggest raised intracranial pressure-for example, owing to hydrocephalus or a brain tumour Rapidly increasing head circumference (more than 1 cm/week); persistent morning headache and vomiting worse in the morning Specialist referral 5 May suggest raised intracranial pressure-for example, owing to meningitis (also see NICE clinical guideline on bacterial meningitis and meningococcal septicaemia 5 ) Altered responsiveness-for example, lethargy or irritability Trial of cows' milk exclusion and specialist referral 3 May suggest cows' milk protein allergy (also see NICE clinical guideline on food allergy in children and young people 3 )
Infants and children with, or at high risk of, atopy *Specialist refers to a paediatrician with the skills, experience, and competency necessary to deal with the particular clinical concern that has been identified by the referring healthcare professional, usually a consultant general paediatrician. Depending on the clinical circumstances, specialist may also refer to a paediatric surgeon, paediatric gastroenterologist, or a doctor with the equivalent skills and competency.
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[fig] : Do not offer an upper gastrointestinal contrast study to diagnose or assess the severity of GORD in infants, children, and young people. [Based on the experience and opinion of theGDG.] Perform an urgent (same day) upper gastrointestinal contrast study for infants with unexplained bile stained vomiting. Explain to the parents and carers that this is needed to rule out serious disorders such as intestinal obstruction caused by midgut volvulus.[Based on the experience and opinion of the GDG.] Consider an upper gastrointestinal contrast study for children and young people with a history of bile stained vomiting, particularly if it is persistent or recurrent. [Based on the experience and opinion of the GDG.] Offer an upper gastrointestinal contrast study for children and young people with a history of GORD who present with dysphagia. [Based on the experience and opinion of the GDG.] Endoscopy and oesophageal pH or impedance monitoring Refer infants, children, and young people to a specialist for a possible upper gastrointestinal endoscopy with biopsies if there is: -Haematemesis (blood stained vomit) not caused by swallowed blood (assessment to take place on the same day if clinically indicated; also see table 1) -Melaena (black, foul smelling stool) (assessment to take place on the same day if clinically indicated; also see table 1) -Dysphagia (assessment to take place on the same day if clinically indicated) -No improvement in regurgitation after age 1 year -Persistent faltering growth associated with overt regurgitation -Unexplained distress in children and young people with communication difficulties -Retrosternal, epigastric, or upper abdominal pain that needs ongoing medical treatment or is refractory to medical treatment -Feeding aversion and a history of regurgitation -Unexplained iron deficiency anaemia -A referral for fundoplication -Back arching or features of Sandifer's syndrome.[Based on high, moderate, and low quality evidence from observational studies and on the experience and opinion of the GDG.] Consider performing an oesophageal pH study (or combined oesophageal pH and impedance monitoring if available) in infants, children, possible need for fundoplication (see second point under "Investigations for surgery") -A suspected diagnosis of Sandifer's syndrome. [/fig]
[table] Table Table 1|: "Red flag" symptoms suggesting conditions other than gastro-oesophageal reflux in infants and children Suggested action* Possible diagnostic implication Symptom or sign Gastrointestinal Paediatric surgery referral May suggest hypertrophic pyloric stenosis in infants up to 2 months old Frequent, forceful (projectile) vomiting Paediatric surgery referral May suggest intestinal obstruction Bile stained (green or yellow-green) vomit Specialist referral for investigation May suggest an important and potentially serious bleed from the oesophagus, stomach, or upper gut [/table]