The following guidance is based on the best available evidence. The full guideline gives details of the methods and the evidence used to develop the guidance.
People have the right to be involved in discussions and make informed decisions about their care, as described in NICE's information on making decisions about your care.
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Infants, children and young people are defined as follows:
infants: under 1 year
children: 1 to under 12 years
young people: 12 to under 18 years.
Gastro‑oesophageal reflux (GOR) is 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 occurs more frequently after feeds/meals. In many infants, GOR is associated with a tendency to 'overt regurgitation' – the visible regurgitation of feeds.
Gastro‑oesophageal reflux disease (GORD) refers to gastro‑oesophageal reflux that causes symptoms (for example, discomfort or pain) severe enough to merit medical treatment, or to gastro‑oesophageal reflux‑associated complications (such as oesophagitis or pulmonary aspiration). In adults, the term GORD is often used more narrowly, referring specifically to reflux oesophagitis.
Marked distress There is very limited evidence, and no objective or widely accepted clinical definition, for what constitutes 'marked distress' in infants and children who are unable to adequately communicate (expressively) their sensory emotions. In this guideline, 'marked distress' refers to an outward demonstration of pain or unhappiness that is outside what is considered to be the normal range by an appropriately trained, competent healthcare professional, based on a thorough assessment. This assessment should include a careful analysis of the description offered by the parents or carers in the clinical context of the individual child.
Occult reflux refers to the movement of part or all of the stomach contents up the oesophagus, but not to the extent that it enters the mouth or is obvious to the child, parents or carers, or observing healthcare professional. There is no obvious, visible regurgitation or vomiting. It is sometimes referred to as silent reflux.
Overt regurgitation refers tothe voluntary or involuntary movement of part or all of the stomach contents up the oesophagus at least to the mouth, and often emerging from the mouth. Regurgitation is in principle clinically observable, so is an overt phenomenon, although lesser degrees of regurgitation into the mouth might be overlooked.
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. In this guideline this is most likely to be 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.
Recognise regurgitation of feeds as a common and normal occurrence in infants that:
is due to gastro‑oesophageal reflux (GOR) – a normal physiological process in infancy
does not usually need any investigation or treatment
is managed by advising and reassuring parents and carers.
Be aware that in a small proportion of infants, GOR 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 (GORD).
Give advice about GOR and reassure 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 old)
does not usually need further investigation or treatment.
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 (green or yellow‑green) vomiting or haematemesis (blood in vomit)
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.
In infants, children and young people with vomiting or regurgitation, look out for the 'red flags' in table 1, which may suggest disorders other than GOR. Investigate or refer using clinical judgement.
| Gastrointestinal symptoms and signs | Possible diagnostic implications | Suggested actions |
|---|---|---|
|
Frequent, forceful (projectile) vomiting |
May suggest hypertrophic pyloric stenosis in infants up to 2 months old |
Paediatric surgery referral |
|
Bile‑stained (green or yellow‑green) vomit |
May suggest intestinal obstruction |
Paediatric surgery referral |
|
Haematemesis (blood in vomit) with the exception of swallowed blood, for example, following a nose bleed or ingested blood from a cracked nipple in some breast‑fed infants |
May suggest an important and potentially serious bleed from the oesophagus, stomach or upper gut |
Specialist referral |
|
Onset of regurgitation and/or vomiting after 6 months old or persisting after 1 year old |
Late onset suggests a cause other than reflux, for example a urinary tract infection (also see the NICE guideline on urinary tract infection in under 16s) Persistence suggests an alternative diagnosis |
Urine microbiology investigation Specialist referral |
|
Blood in stool |
May suggest a variety of conditions, including bacterial gastroenteritis, infant cows' milk protein allergy (also see the NICE guideline on food allergy in under 19s) or an acute surgical condition |
Stool microbiology investigation Specialist referral |
|
Abdominal distension, tenderness or palpable mass |
May suggest intestinal obstruction or another acute surgical condition |
Paediatric surgery referral |
|
Chronic diarrhoea |
May suggest cows' milk protein allergy (also see the NICE guideline on food allergy in under 19s) |
Specialist referral |
| Systemic symptoms and signs | Possible diagnostic implications | Suggested actions |
|---|---|---|
|
Appearing unwell Fever |
May suggest infection (also see the NICE guideline on fever in under 5s) |
Clinical assessment and urine microbiology investigation Specialist referral |
|
Dysuria |
May suggest urinary tract infection (also see the NICE guideline on urinary tract infection in under 16s) |
Clinical assessment and urine microbiology investigation Specialist referral |
|
Bulging fontanelle |
May suggest raised intracranial pressure, for example, due to meningitis (also see the NICE guideline on bacterial meningitis and meningococcal disease) |
Specialist referral |
|
Rapidly increasing head circumference (more than 1 cm per week) Persistent morning headache, and vomiting worse in the morning |
May suggest raised intracranial pressure, for example, due to hydrocephalus or a brain tumour |
Specialist referral |
|
Altered responsiveness, for example, lethargy or irritability |
May suggest an illness such as meningitis (also see the NICE guideline on bacterial meningitis and meningococcal disease) |
Specialist referral |
|
Infants and children with, or at high risk of, atopy |
May suggest cows' milk protein allergy (also see the NICE guideline on food allergy in under 19s) |
Specialist referral |
Do not routinely investigate or treat for GOR if an infant or child without overt regurgitation presents with only 1 of the following:
unexplained feeding difficulties (for example, refusing to feed, gagging or choking)
distressed behaviour
faltering growth
chronic cough
hoarseness
a single episode of pneumonia.
Consider referring infants and children with persistent back arching or features of Sandifer's syndrome (episodic torticollis with neck extension and rotation) for specialist assessment.
Recognise the following as possible complications of GOR in infants, children and young people:
reflux oesophagitis
recurrent aspiration pneumonia
frequent otitis media (for example, more than 3 episodes in 6 months)
dental erosion in a child or young person with a neurodisability, in particular cerebral palsy.
Recognise the following as possible symptoms of GOR in children and young people:
heartburn
retrosternal pain
epigastric pain.
Be aware that GOR is more common in children and young people with asthma, but it has not been shown to cause or worsen it.
Be aware that some symptoms of a non‑IgE‑mediated cows' milk protein allergy can be similar to the symptoms of GORD, especially in infants with atopic symptoms, signs and/or a family history. If a non‑IgE‑mediated cows' milk protein allergy is suspected, see the NICE guideline on food allergy in under 19s.
When deciding whether to investigate or treat, take into account that the following are associated with an increased prevalence of GORD:
premature birth
parental history of heartburn or acid regurgitation
obesity
hiatus hernia
history of congenital diaphragmatic hernia (repaired)
history of congenital oesophageal atresia (repaired)
a neurodisability.
GOR only rarely causes episodes of apnoea or apparent life‑threatening events (ALTEs), but consider referral for specialist investigations if it is suspected as a possible factor following a general paediatric assessment.
For children and young people who are obese and have heartburn or acid regurgitation, advise them and their parents or carers (as appropriate) that losing weight may improve their symptoms (also see the NICE guideline on obesity).
Do not offer an upper gastrointestinal (GI) contrast study to diagnose or assess the severity of GORD in infants, children and young people.
Perform an urgent (same day) upper GI 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 due to mid‑gut volvulus.
Consider an upper GI contrast study for children and young people with a history of bile‑stained vomiting, particularly if it is persistent or recurrent.
Offer an upper GI contrast study for children and young people with a history of GORD presenting with dysphagia.
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.
Arrange a specialist hospital assessment for infants, children and young people for a possible upper GI 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 1 year old
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 therapy or is refractory to medical therapy
feeding aversion and a history of regurgitation
unexplained iron‑deficiency anaemia
a suspected diagnosis of Sandifer's syndrome.
Consider performing an oesophageal pH study (or combined oesophageal pH and impedance monitoring if available) in infants, children and young people with:
suspected recurrent aspiration pneumonia
unexplained apnoeas
unexplained non‑epileptic seizure‑like events
unexplained upper airway inflammation
dental erosion associated with a neurodisability
frequent otitis media
a possible need for fundoplication (see the recommendations in the section on surgery for GORD)
a suspected diagnosis of Sandifer's syndrome.
Consider performing an oesophageal pH study without impedance monitoring in infants, children and young people if, using clinical judgement, it is thought necessary to ensure effective acid suppression.
Investigate the possibility of a urinary tract infection in infants with regurgitation if there is:
faltering growth
late onset (after the infant is 8 weeks old)
frequent regurgitation and marked distress.
Do not use positional management to treat GOR in sleeping infants. In line with NHS advice on sudden infant death syndrome (SIDS), infants should be placed on their back when sleeping.
In breast‑fed infants with frequent regurgitation associated with marked distress, ensure that a person with appropriate expertise and training carries out a breastfeeding assessment.
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 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, cornstarch, locust bean gum or carob bean gum).
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 to 2 weeks. If the alginate therapy is successful continue with it, but try stopping it at intervals to see if the infant has recovered.
In formula‑fed infants, if the stepped‑care approach is unsuccessful (see the recommendation on stepped-care approach for formula-fed infants with frequent regurgitation associated with marked distress), stop the thickened formula and offer alginate therapy for a trial period of 1 to 2 weeks. If the alginate therapy is successful continue with it, but try stopping it at intervals to see if the infant has recovered.
Not all PPIs and H2RAs are licensed for use in children and those that are licensed vary in the age that they are licensed from. For licensing and prescribing information see the individual SPCs and BNF for children. MHRA drug safety updates have been issued for PPIs, covering hypomagnesaemia, the increased risk of fracture with long-term use and very low risk of subacute cutaneous lupus erythematosus.
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 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.
Consider a 4‑week trial of a PPI or H2RA 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
recur after stopping the treatment.
When choosing between PPIs and H2RAs, take into account:
the availability of age‑appropriate preparations
the preference of the parent (or carer), child or young person (as appropriate)
local procurement costs.
Offer PPI or H2RA treatment to infants, children and young people with endoscopy‑proven reflux oesophagitis, and consider repeat endoscopic examinations as necessary to guide subsequent treatment.
Do not offer metoclopramide, domperidone or erythromycin to treat GOR or GORD unless all the following conditions are met:
the potential benefits outweigh the risk of adverse events
other interventions have been tried
there is specialist paediatric healthcare professional agreement for its use.
Metoclopramide, domperidone and erythromycin are not licensed for use in children. Metoclopramide is contraindicated in infants, and should only be prescribed for short-term use (up to 5 days). For licensing and prescribing information see the individual SPCs and BNF for children. MHRA drug safety updates have been issued covering risk of cardiac side effects with domperidone and:
Only consider enteral tube feeding to promote weight gain in infants and children with overt regurgitation and faltering growth if:
other explanations for poor weight gain have been explored and/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 it as soon as possible
an exit strategy, if appropriate, to stop it as soon as possible.
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.
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.
Offer an upper GI endoscopy with oesophageal biopsies for infants, children and young people before deciding whether to offer fundoplication for presumed GORD.
Consider performing other investigations such as an oesophageal pH study (or combined oesophageal pH and impedance monitoring if available) and an upper GI contrast study for infants, children and young people before deciding whether to offer fundoplication.
Consider fundoplication in infants, children and young people with severe, intractable GORD if:
appropriate medical treatment has been unsuccessful or
feeding regimens to manage GORD prove impractical, for example, in the case of long‑term, continuous, thickened enteral tube feeding.