Changes

July 2024 — reviewed. A literature search was conducted in May 2024 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. The recommendations have been updated in line with current evidence in the literature. The topic structure has been amended to improve clarity and navigation. A link to the First Steps Nutrition Trust resources has been provided, which gives information about infant formula milk requirements and different anti-reflux infant formula milk available.

Update

Goals

To support primary healthcare professionals to:

• Know when to suspect a diagnosis of gastro-oesophageal reflux disease (GORD) in children.
• Accurately assess a child with suspected GORD, including for red flags suggesting a serious underlying diagnosis or complication.
• Offer appropriate reassurance, information, and advice in primary care.
• Offer management, including feeding advice and modification, a trial of thickened formula (if formula-fed), a trial of alginate therapy, and a trial of acid-suppressing therapy, if clinically indicated.
• Arrange hospital admission or referral to paediatrics or paediatric gastroenterology if clinically indicated.

Outcome measures

Audit criteria

QOF indicators

QIPP - Options for local implementation

No QIPP indicators were found during the review of this topic.

NICE quality standards

Gastro-oesophageal reflux in children and young people

• Parents and carers attending postnatal appointments are given information about gastro‑oesophageal reflux (GOR) in infants.
• Breast‑fed infants with frequent regurgitation associated with marked distress have their feeding assessed.
• Formula‑fed infants with frequent regurgitation associated with marked distress have their symptoms managed using a stepped-care approach.
• Infants with frequent regurgitation associated with marked distress have a trial of alginate therapy if first‑line management is unsuccessful.
• Infants and children are not investigated or treated for gastro‑oesophageal reflux disease (GORD) if they have no visible regurgitation and only 1 associated symptom.
• Infants and children are not prescribed acid‑suppressing drugs if visible regurgitation is an isolated symptom.
• Infants, children, and young people do not have an upper gastrointestinal contrast study to diagnose or assess the severity of GORD.
• Infants, children, and young people are not prescribed domperidone, metoclopramide, or erythromycin to manage GOR or GORD without specialist paediatric advice.
• Infants, children, and young people with vomiting or regurgitation and any 'red flag' symptoms are referred to specialist care with investigations as appropriate.

[NICE, 2016]

What is it?

• Gastro-oesophageal reflux (GOR) is the passage of gastric contents into the oesophagus. It is considered physiological in infants when symptoms are absent or not troublesome.
• Gastro-oesophageal reflux disease (GORD) in children is the presence of troublesome symptoms (for example, discomfort or pain) or complications (such as oesophagitis or pulmonary aspiration) arising from GOR.
• In adults, the term GORD usually refers specifically to reflux oesophagitis.
• Regurgitation (also known as 'posseting') is the voluntary and involuntary movement of part or all of the stomach contents up the oesophagus at least as far as the mouth and often emerging from the mouth.
  • In infants (younger than 1 year of age), regurgitation may be considered entirely normal.
  • In older children, it may be a symptom of GOR or GORD.

What causes it?

• Gastro-oesophageal reflux (GOR) occurs as a result of transient lower oesophageal sphincter relaxation [Baird, 2015; Rybak, 2017; Marsh, 2019].
  • Several anatomical and physiological features make infants younger than one year of age more prone to GOR than older children and adults. These include:
    • Short, narrow oesophagus [Baird, 2015].
    • Delayed gastric emptying [Rosen, 2018].
    • Shorter, lower oesophageal sphincter that is slightly above, rather than below, the diaphragm [Marsh, 2019; Harris, 2022].
    • Liquid diet and high caloric requirement, putting a strain on gastric capacity [Baird, 2015; Rybak, 2017].
    • Larger ratio of gastric volume to oesophageal volume [Marsh, 2019].
    • Consumption of relatively large quantities of liquid feeds [Baird, 2015; Marsh, 2019].
    • Infants are frequently recumbent [Baird, 2015; Rybak, 2017; Marsh, 2019].

What are the risk factors?

• Risk factors for developing gastro-oesophageal reflux disease (GORD) in children include [Chanchlani, 2017] [Rosen, 2018] [NICE, 2019]:
  • Preterm birth.
  • Parental history of heartburn or acid regurgitation.
  • Obesity.
  • Hiatus hernia.
  • History of congenital diaphragmatic hernia (repaired).
  • History of congenital oesophageal atresia (repaired).
  • Neurodevelopmental disorders such as cerebral palsy or genetic conditions such as Down syndrome.
  • Respiratory conditions, including asthma and cystic fibrosis.

How common is it?

It can be difficult to clinically differentiate between gastro-oesophageal reflux (GOR) and gastro-oesophageal reflux disease (GORD) in infants and children, and symptoms are often non-specific. It is, therefore, challenging to estimate the true prevalence and burden of GORD in children as it may be under or overestimated [Rosen, 2018]. Reported prevalence rates also vary depending on the study population, data collection method, and criteria used to define symptoms [Singendonk, 2019].

• A UK primary care database cross-sectional study of GORD in children found [Ruigomez, 2010a]:
  • The incidence decreased with age from 1.48 per 1000 person-years among 1-year-old children until the age of 12 years.
• A systematic review of 25 studies (n = 487,969 infants and children) found [Singendonk, 2019]:
  • In infants aged 0–18 months, GORD symptoms are present in more than 25% of infants on a daily basis, and steadily decline in frequency with almost complete resolution of symptoms at the age of 12 months.
  • In children older than 18 months, there is a wide variation in prevalence rates between different studies, with weekly symptoms present in more than 10% of children, and monthly symptoms in more than 25% of children.
• Regurgitation of feeds is common and occurs in at least 40% of infants, and usually begins before the infant is 8 weeks of age [NICE, 2019].
• Symptoms typically peak at 4–6 months, and improve by 12 months of age [Marsh, 2019].

What are the complications?

• Most children with gastro-oesophageal reflux (GOR) do not develop any complications. Possible complications of untreated or undertreated gastro-oesophageal reflux disease (GORD) include [Rosen, 2018] [NICE, 2019]:
  • Reflux oesophagitis.
  • Oesophageal stricture.
  • Recurrent aspiration pneumonia. See the CKS topic on Cough - acute with chest signs in children for more information.
  • Recurrent acute otitis media. See the CKS topic on Otitis media - acute for more information.
  • Dental erosion, particularly in a child with a neurodevelopmental disorder such as cerebral palsy.
  • Iron deficiency anaemia. See the CKS topic on Anaemia - iron deficiency for more information.
  • Faltering growth. See the CKS topic on Faltering growth for more information.
  • Rarely, apnoea or apparent life-threatening events (episodes of combinations of apnoea, colour change, change in muscle tone, choking, and gagging) [Baird, 2015].
  • GORD may negatively affect parent-infant bonding during feeding and lead to parental/carer concern [Lopez, 2020].

What is the prognosis?

The natural history of gastro-oesophageal reflux (GOR) in infants is generally a self‐limiting condition that improves with age, but symptoms may persist in some children [Lopez, 2020] [Tighe, 2023].

• The National Institute for Health and Care Excellence (NICE) guideline cites evidence from observational studies that symptoms of GOR usually begin before the age of 8 weeks and resolve before one year of age in 90% of infants [NICE, 2019].
• Improvement in regurgitation and GORD is thought to occur because of [Tighe, 2023]:
  • An increase in the length of the oesophagus.
  • An increase in tone of the lower oesophageal sphincter.
  • A more upright posture.
  • A more solid diet.
• A UK primary care database cohort study of children aged 1–17 years (n = 1242) with newly diagnosed GORD based on symptoms were followed up for a mean duration of 4 years to assess for the presence of complications [Ruigomez, 2010b]:
  • 40 children had an endoscopy-confirmed new diagnosis of reflux oesophagitis (incidence of 10.9 cases per 1000 person-years).
  • There was a two-fold increased risk of an extra-oesophageal condition such as asthma, pneumonia, cough, or chest pain compared with children with no diagnosis of GORD.
• Age of onset of GORD symptoms less than 5 years and the use of acid suppression therapy at the time of initial diagnosis may result in a worse prognosis [Rosen, 2018].

When should I suspect GORD in children?

 It may be clinically difficult to differentiate between gastro-oesophageal reflux (GOR) and gastro-oesophageal reflux disease (GORD). Symptoms of GORD vary with age, are non-specific, and there is no reliable diagnostic test.

• Suspect a diagnosis of GOR in an infant if there is effortless regurgitation of stomach contents.
• Suspect a diagnosis of GORD in an infant up to one year of age or young child if they present with visible regurgitation and one or more of the following associated symptoms:
  • Distressed behaviour such as excessive crying, crying while feeding, irritability, and/or back arching or posturing.
    • If there is associated episodic torticollis with neck extension and rotation, this may indicate Sandifer syndrome, a very rare movement disorder that causes head, neck, and back arching spasms.
  • Hoarseness and/or chronic cough.
  • A single episode of pneumonia. See the CKS topic on Cough - acute with chest signs in children for more information.
  • Unexplained feeding difficulties, such as refusing to feed, gagging, or choking.
  • Faltering growth. See the CKS topic on Faltering growth for more information.
• Be aware that children over one year of age may present with heartburn, retrosternal pain, and epigastric pain.

How should I assess a child with suspected GORD?

If a diagnosis of gastro-oesophageal reflux (GOR) or gastro-oesophageal reflux disease (GORD) is suspected in an infant or young child:

• Ask the parent(s) or carer(s) about:
  • Any symptoms, their onset and age at first presentation, duration, aggravating and relieving factors.
    • Symptoms of regurgitation and GORD usually begin before the age of 8 weeks and resolve in 90% of infants before one year of age.
    • Onset of regurgitation and/or vomiting after six months of age, or persisting after one year, may indicate an alternative diagnosis.
  • The pattern and estimated volume of regurgitation or vomiting (such as nocturnal, immediately post-prandial, long after meals, digested or undigested).
    • Regurgitation may be frequent, with 5% of affected infants having six or more episodes each day.
  • The feeding and diet history, including whether breast-, formula-, or mixed feeding, and any feeding problems, including resistance or refusal to feed or dietary restrictions.
    
    • If bottle-fed, ask about the type of formula used; how it is prepared; the size, timing, frequency, and duration of feeds; and the volume consumed over 24 hours.
    • If breastfed, ask about the timing, frequency, and duration of feeds; quality of milk supply; and any feeding problems. See the CKS topic on Breastfeeding problems for more information.
  • Wet and dirty nappy frequency and any change.
  • Any red flag features that may suggest an alternative diagnosis.
  • Any known risk factors or complications.
  • Any family history of gastrointestinal conditions or risk factors.
  • Any previous treatments or feeding interventions.
  • The impact on parents/carers, how they are coping, and the level of parental concern or distress; any perinatal mental health issues; level of social support.
• Examine the child. Be aware that examination is usually normal in a child with GOR or GORD.
  • Check temperature, fontanelle, alertness, and hydration status to assess for signs of an acute or serious condition or complication.
  • Examine the mouth for evidence of dental erosion.
  • Examine the abdomen to assess for discomfort, distension, or palpable mass, which may indicate an alternative diagnosis.
  • Examine the chest for respiratory signs such as stridor, cough, or wheeze which may be extra-oesophageal manifestations or suggest other pathology.
• Review the infant or child's neurodevelopmental history, weight, and growth.
  • Review head circumference and weight using centile charts to assess for faltering growth and any other pathology. See the CKS topic on Faltering growth for more information.
• Arrange for a feeding assessment, for example, by a health visitor, if it has not already been done.
• Be aware there is no simple, reliable, and accurate diagnostic test to confirm whether the condition is GOR or GORD.

What else might it be?

If an infant or young child has regurgitation and vomiting, the following 'red flag' features may suggest a potentially serious or life-threatening alternative diagnosis:

• Frequent, forceful (projectile) vomiting — suggests hypertrophic pyloric stenosis in infants up to two months of age.
• Bile-stained (green or yellow-green) vomit — suggests intestinal obstruction, for example, due to Hirschsprung disease, intestinal atresia, mid-gut volvulus, or intussusception.
• Abdominal distension, tenderness, or palpable mass — suggests intestinal obstruction or another acute surgical condition such as strangulated hernia or anatomic abnormality. See the CKS topic on Scrotal pain and swelling for more information.
• Blood-stained vomit (haematemesis) not caused by blood ingested from a nosebleed or cracked maternal nipple or melaena — suggests an upper gastrointestinal bleed.
• Bulging fontanelle or altered responsiveness (lethargy or irritability); rapidly increasing head circumference (more than 1 cm each week); vomiting worse in the morning or at night; persistent morning headache — suggests raised intracranial pressure (for example, caused by meningitis, hydrocephalus, or brain tumour). See the CKS topics on Meningitis - bacterial meningitis and meningococcal disease and Childhood cancers - recognition and referral for more information.
• Micro- or macrocephaly — may be associated with neurodevelopmental delay and other intracranial pathology.
• Blood in the stool — may suggest conditions such as cow's milk allergy, gastroenteritis, inflammatory bowel disease, or an acute surgical condition such as intussusception or mid-gut volvulus. See the CKS topics on Cow's milk allergy in children, Crohn's disease, Gastroenteritis, and Ulcerative colitis for more information.
• Chronic diarrhoea, may be associated with atopy — may suggest cow's milk allergy or food allergy. See the CKS topics on Cow's milk allergy in children and Food allergy for more information.
• Dysuria — suggests urinary tract infection (UTI). See the CKS topic on Urinary tract infection - children for more information.
• Appearing unwell or fever, weight loss — suggests systemic illness, infection, and/or sepsis. See the CKS topic on Feverish children - risk assessment and management and Sepsis for more information.
• Onset of regurgitation and/or vomiting after 6 months of age or persisting after one year of age — suggests another cause for symptoms, such as UTI. See the CKS topic on Urinary tract infection - children for more information.

Scenario: Management of GORD in children

From birth to 24 months.

Gaviscon® Infant

Omeprazole

Search strategy

Scope of search

A literature search was conducted for guidelines and systematic reviews on primary care management of gastro-oesophageal reflux in children.

Search dates

February 2019 - May 2024

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE (searched 11th February 2019). The search strategy was adapted to search The Cochrane Library databases. 

S12    S6 AND S11
S11    S7 OR S8 OR S9 OR S10
S10    AB ( (child* or infant or infants or infancy or baby or babies or paediatric* or pediatric* or adolescen* or boy or boys or girl or girls or young or youth*) ) OR TI ( (child* or infant or infants or infancy or baby or babies or paediatric* or pediatric* or adolescen* or boy or boys or girl or girls or young or youth*) )
S9    (MH "Pediatrics+")
S8    (MH "Infant+")
S7    (MH "Child+")
S6    S1 OR S2 OR S3 OR S4 OR S5
S5    AB ( (posseting or possetting) ) OR TI ( (posseting or possetting) )
S4    AB (regurgitation) OR TI (regurgitation)
S3    AB (gastro* N3 reflux) OR TI (gastro* N3 reflux)
S2    AB ( GORD or GERD ) OR TI ( GORD or GERD )
S1    (MH "Gastroesophageal Reflux+")

Sources of guidelines

• National Institute for Health and Care Excellence (NICE)
• Scottish Intercollegiate Guidelines Network (SIGN)
• Royal College of Physicians
• Royal College of General Practitioners
• Royal College of Nursing
• NICE Evidence
• World Health Organization
• Guidelines International Network
• TRIP database
• Agency for Healthcare Research and Quality
• Institute for Clinical Systems Improvement
• National Health and Medical Research Council (Australia)
• Royal Australian College of General Practitioners
• British Columbia Medical Association
• Canadian Medical Association
• Alberta Medical Association
• Michigan Quality Improvement Consortium
• Singapore Ministry of Health
• National Resource for Infection Control
• RefHELP NHS Lothian Referral Guidelines
• Medline (with guideline filter)
• Driver and Vehicle Licensing Agency
• NHS Health at Work (occupational health practice)

Sources of systematic reviews and meta-analyses

• The Cochrane Library:
  • Systematic reviews
  • Protocols
  • Database of Abstracts of Reviews of Effects
• Medline (with systematic review filter)
• EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

• NIHR Health Technology Assessment programme
• The Cochrane Library:
  • NHS Economic Evaluations
  • Health Technology Assessments
• Canadian Agency for Drugs and Technologies in Health
• International Network of Agencies for Health Technology Assessment

Sources of randomized controlled trials

• The Cochrane Library:
  • Central Register of Controlled Trials
• Medline (with randomized controlled trial filter)
• EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

• Bandolier
• Drug and Therapeutics Bulletin
• TRIP database
• Central Services Agency COMPASS Therapeutic Notes

Sources of national policy

• Department of Health
• Health Management Information Consortium (HMIC)

Patient experiences

• Healthtalk
• BMJ - Patient Journeys

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

• British National Formulary (BNF)
• electronic Medicines Compendium (eMC)
• European Medicines Agency (EMEA)
• LactMed
• Medicines and Healthcare products Regulatory Agency (MHRA)
• REPROTOX
• Scottish Medicines Consortium
• Stockley's Drug Interactions
• TERIS
• TOXBASE
• Micromedex
• UK Medicines Information

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

• Clinical accuracy.
• Consistency with other providers of clinical knowledge for primary care.
• Accuracy of implementation of national guidance (in particular NICE guidelines).
• Usability.

Principles of the consultation process

• The process is inclusive and any individual may participate.
• To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
• Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
• Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
• External reviewers are not paid for commenting on the draft topics.
• Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
• All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
• All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

• Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
• Stakeholders identified from the following groups are invited to review draft topics:
  • Experts in the topic area.
  • Professional organizations and societies (for example, Royal Colleges).
  • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
  • Guideline development groups where the topic is an implementation of a guideline.
  • The British National Formulary team.
  • The editorial team that develop MeReC Publications.
• Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.

Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

• Topic selection
• Scoping of topic
• Selection of clinical scenarios
• First draft internal review
• Second draft internal review
• External review
• Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

• Animal studies
• Original research is not written in English

Possible exclusions for reviewed literature:

• Sample size too small or study underpowered
• Bias evident or promotional literature
• Population not relevant
• Intervention/treatment not relevant
• Outcomes not relevant
• Outcomes have no clear evidence of clinical effectiveness
• Setting not relevant
• Not relevant to UK
• Incorrect study type
• Review article
• Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

• Feasibility
  • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
• Organizational and Financial Impact Analysis
• Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
  • Eligible population
  • Current interventions
  • Likely uptake of new intervention or recommendation
  • Cost of the current or new intervention mix
  • Impact on other costs
  • Condition-related costs
  • In-direct costs and service impacts
  • Time dependencies
• Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

• Personal financial interests
• Personal family interest
• Personal non-financial interest
• Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.