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Gastro-oesophageal reflux (GOR) is a common problem in infants, affecting nearly half of babies under the age of one. It normally starts within the first eight weeks of life, with preterm infants and those with neurodevelopmental disorders at a highly increased risk of being affected. GOR involves the regurgitation of foods from the stomach into the oesophagus and often out of the mouth, especially after feeding. Babies with reflux may often be hard to comfort and may refuse feeding, and parents/caregivers can become very concerned about the impact on their baby’s overall health.

In a small proportion of infants, reflux is associated with ‘marked distress’ or may lead to complications that need clinical management (e.g. oesophagitis or pulmonary aspiration) where it is called gastro-oesophageal reflux disease (GORD).

The term ‘marked distress’ is defined as substantial pain or discomfort that is judged to be outside the infant’s normal range. This judgement should be made by an appropriately trained healthcare professional, based on an assessment of parent reports and the infant’s clinical background.

  • About the patient

    Lucia is seven weeks old and has been regurgitating food gently after feeding for the past two weeks. She has been crying more than usual and has been refusing feeding, which has made her parents extremely worried and anxious for a clinical intervention.

  • Treatment goals

    The main aims of treatment are to alleviate the infant’s symptoms, promote normal growth and prevent complications, while addressing the parent/caregiver’s concerns. Nine out of ten cases of GOR will resolve by 12 months without treatment but, in infants with marked distress (GORD), pharmacological intervention may be indicated.

  • Challenges faced

    1. The main challenge of managing infants with GOR is identifying whether they have marked distress. This will determine the diagnosis of GOR or GORD and hence the treatment. What warrants marked distress will be individual to each infant and judgement should be made in the context of that infant’s typical behaviour. For instance, prolonged periods of crying may be normal for some infants but for others it is a rare event indicating they are in discomfort.

    2. Some infants with a non-IgE-mediated cow’s milk protein allergy present with symptoms that are difficult to distinguish from GOR and GORD. Other conditions that can present with reflux-like symptoms and are worth considering when making a diagnosis include acute gastroenteritis, intestinal obstruction, pyloric stenosis and infections.

    3. Parents/caregivers and clinicians can be overwhelmed by the large amounts of information in the public domain on the topic of reflux and it can be challenging to identify reliable clinical information. Clinicians need to take extra care to educate parents/caregivers about reflux and communicate treatment decisions to parents/caregivers in terms they can understand.

    4. It is of vital importance to identify red flag symptoms which can be indicative of a more serious condition that may warrant referral (depending on clinical judgement):

      • Forceful vomiting
      • Blood in vomit or stool
      • Failure to thrive
      • Frequent prolonged crying
      • Abdominal distension, tenderness, or palpable mass
      • Bulging fontanelle or altered responsiveness
      • Rapidly increasing head circumference
      • Bile-stained vomit
      • Atopy
      • Symptoms of urinary tract infection
      • Fever
      • Chronic diarrhoea
      • Onset of symptoms after 6 months of age or continued symptoms beyond one year old

  • Consultation advice

    The first step in a consultation should be a detailed discussion with Lucia’s parents/caregivers on her symptoms and symptom history. This should include a detailed feeding history and an evaluation of risk factors for GORD (e.g. premature birth). During the history taking, it is important to establish whether Lucia’s behaviour would qualify as ‘marked distress’ compared to her usual behaviour, while remaining on the lookout for any red flags which might be indicative of conditions other than GOR and GORD.

    Lucia’s main symptom is regurgitation of food and it is important to establish whether this is of serious clinical concern. If regurgitation is frequent and forceful (projectile), blood-stained, bile-stained or worse in the mornings you should seek urgent specialist help for further investigation. Another key point in the history taking and examination is determining whether Lucia is failing to thrive. Centile charts can be useful for assessing growth, however it is important to consider her growth rates in the context of her clinical history and socio-economic background. This investigation reveals that, despite being reluctant to feed, Lucia’s growth rate is in the normal range.

    • When should I prescribe treatments?

    If an infant’s symptoms are consistent with GOR, reassure the patients how common reflux is and that it will likely resolve without treatment. However, Lucia’s crying is more frequent than usual and would therefore qualify as marked distress. Consequently, her symptoms are more consistent with a diagnosis of GORD and you should consider treatment.

    Treating GORD in breastfed infants

    You should offer breastfeeding mothers an assessment with a Health Visitor or a Breastfeeding Councillor who will address any feeding issues. However, the symptoms of infant gastro-intestinal reflux are rarely severe enough to warrant cessation of breastfeeding.

    Treating GORD in formula-fed infants

    In children who must be formula-fed*, use a stepped care approach to treatment:

    1. Review feeding history
    2. Then advise the caregivers to reduce feed volumes if they are excessive for the infant’s weight
    3. Then offer a trial of smaller, more frequent feeds, unless feeds are already small and frequent
    4. Then offer a trial of a thickened formula (if they do not want to switch formula, caregivers can add a thickening agent to the feed, which has the same effect)

    Lastly, you should advise Lucia’s parents and carers that they should return for review if:

    • - Lucia’s regurgitation becomes more violent
    • - Lucia’s vomit contains bile or blood
    • - There are new concerns, such as marked distress, feeding difficulties or faltering growth
    • - Symptoms continue beyond the first year of life

    *Breastfeeding is the best feeding method for infants and is strongly recommended where possible.

    • When should I prescribe alginates?
    • NICE recommends alginates as the first-line pharmacological intervention for treating GORD in infants. If Lucia shows no improvement following alterations to her feeding, she should be prescribed a 1–2 week trial of an infant-appropriate alginate. Compared to thickened feeds, alginates have the advantages of adjustable dosing based on the infant’s size and appropriateness for both breastfed and bottle-fed infants. In an infant setting it is important to check the prescribing information of medications for the appropriate dosing.

    • When should I prescribe acid suppressing drugs?
    • If Lucia’s reflux does not desist following dietary interventions or alginate therapy, then consider stepping up her treatment to H2RA or PPI therapy for 4 weeks. Clinicians should be cognisant of the potential risks when escalating treatment. According to NICE, there is no evidence that acid-suppressing drugs are effective at reducing regurgitation in infants and, while they are generally well tolerated, they have potential adverse effects (such as acute gastroenteritis and pneumonia) and should only be used when absolutely necessary. If there is no response to acid-supressing drugs or the symptoms recur on stopping treatment, then Lucia should be referred to a specialist.

    • What about infants presenting with more severe symptoms? (see red flags)
    • Itching, flushing, atopic dermatitis, diarrhoea or constipation may indicate a possible cow’s milk allergy. Taking a detailed allergy-focussed clinical history and family history will allow clinicians to identify whether the infant is at increased risk of allergies. If you suspect the infant may have a cow’s milk allergy, consider further testing or a 2–6 week trial eliminating cow’s milk from the infant’s diet. Always seek advice from a paediatric specialist, who can provide advice on timings of elimination and reintroduction, nutrition and follow-up. Bottle-fed infants may be switched to a hypoallergenic formula and, in some cases, breastfed infants may benefit from elimination of cow’s milk from the maternal diet.

      If the infant’s symptoms do not improve despite these dietary changes then they should be referred to a specialist for further assessment.

  • Resources

    • Canani RB, Cirillo P, Roggero P, et al. Therapy with gastric acidity inhibitors increases the risk of acute gastroenteritis and community-acquired pneumonia in children. Pediatrics. 2006;117(5):e817–20.
    • Drug and Therapeutics Bulletin. 2010. Managing gastro-oesophageal reflux in infants. BMJ. 2010; 341.
    • Forum health products limited. Gaviscon infant – Summary of product characteristics (SmPC). 2015. [accessed August 2019].
    • NICE. Cow’s milk protein allergy in children [CKS]. June 2015.
    • NICE. Gastro-oesophageal reflux disease in children and young people: diagnosis and management [NG1]. January 2015.
    • NICE. Gastro-oesophageal reflux in children and young people [QS112]. January 2016.
    • NICE. GORD in children [CKS]. March 2015.
    • NICE. Reflux, regurgitation and heartburn in babies, children and young people [Information for the public]. January 2015.
    • Venter C, Brown T, Meyer R, et al. Better recognition, diagnosis and management of non‑IgE‑mediated cow’s milk allergy in infancy: iMAP—an international interpretation of the MAP (Milk Allergy in Primary Care) guideline. Clin Transl Allergy. 2017;7:26.
    • Venter C, Brown T, Shah N, et al. Diagnosis and management of non-IgE-mediated cow's milk allergy in infancy - a UK primary care practical guide. Clin Transl Allergy. 2013;3(1):23.

This content hub is funded by RB. The view and opinions presented here represent those of the doctors and do not reflect those of RB.

Date of preparation: August 2019

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