Help parents cope with infant GORD without PPIs

Published in Health News and Evidence

Date published: About this date

Clinical content may change after this date. This information is not intended as a substitute for medical advice from a qualified health professional. Health professionals should rely on their own expertise and enquiries when providing medical advice or treatment.

Practice points | Excessive crying — a common problem in new babies | Differentiating between GOR and GORD in infants | PPIs not useful for treating symptoms of infant GORD | Information for parents | Information resources for GPs | References


Crying, irritability and reflux are common and normal behaviours for infants in the first few months of life, but excessive crying, difficulty feeding and chronic vomiting are concerning for new parents.

These symptoms are frequently but incorrectly attributed to GORD, but it is important to differentiate between symptoms of uncomplicated reflux (GOR) and disease (GORD).

Use of PPIs in the management of infants with excessive crying who are thought to have GORD is generally not supported by evidence, as PPIs do not reduce the associated symptoms.

Help new parents cope by advising non-drug treatment options that may improve symptoms of reflux in infants.

Practice points

  • Infants with uncomplicated reflux who are thriving do not require drug treatment.1
  • Advise conservative treatment (feeding modifications, positioning and avoid exposure to tobacco smoke) to reduce risk of reflux in infants.
  • If all other measures have failed and reflux symptoms are problematic or associated with complications, consider trialing PPIs.1 However, there is no strong evidence that PPIs will improve the symptoms of GORD in infants.
  • Seek specialist opinion if:
    • you suspect the infant may have eosinophilic oesophagitis, milk protein allergy, apnoea or aspiration
    • complications arise such as failing to thrive, difficulty swallowing or haematemesis.1,2
  • Consider eliminating dairy products or changing formula in infants with GORD suspected to be associated with cows' milk protein allergy before referral for specialist assessment.2

Excessive crying — a common problem in new babies

Many new parents seek advice from their GP and other health professionals about their new baby's excessive or inconsolable crying in the first few months after birth.

Crying, feeding and sleeping problems are usually related and are distressing for parents as they struggle with the demands of parenthood along with sleep deprivation.3

Excessive crying is reported by parents in about one in five infants at 2 months of age.4 Many more parents also report unsettled behaviour and cite this as the reason for starting formula or complementary feeds.5,6

Although problem crying usually resolves without any long-term complications, it may have implications for the future health and wellbeing of both the mother and child.

Excessive crying increases the risk of premature cessation of breastfeeding and postnatal depression in the mother, and subsequent behavioural problems in the child.3,4,7,8

Is excessive crying caused by reflux?

Excessive crying, fussing and frequent night waking are perceived by many parents to indicate that their baby is not receiving adequate breast milk or that they have acid reflux.5,6

Crying and uncomplicated GOR occur commonly in all infants and may occur simultaneously, but are not necessarily related.

Chronic vomiting and/or regurgitation occur frequently in infants but are usually self-limiting. Most problems with excessive crying, irritability and uncomplicated reflux resolve by 2 years of age.9,10

Differentiating between GOR and GORD in infants

Vomiting or spilling due to reflux of gastric contents is considered a normal pattern of infancy that usually resolves over time. Normal infant GOR occurs in about 40% of babies and is most prominent at four months of age.11 It occurs more frequently with the high levels of sympathetic nervous system arousal associated with excessive crying.11

GORD is distinct from, and much rarer than, normal infant reflux; however, the similarities between the two can lead to confusion. Symptoms are often non-specific and may vary widely from regurgitation to excessive crying and respiratory symptoms.

Excessive crying, irritability and vomiting are frequently attributed to GORD rather than considered as a normal aspect of infancy. Frequent regurgitation (more than five times a day) and persistent feeding difficulties are the most specific clinical indicators of GORD.

Some cases of GORD in infants cause troublesome symptoms and/or complications. Prolonged GORD can cause severe complications such as eosophagitis and failure to thrive.12

In recent years there has been an increase in use of PPIs in infants with excessive crying or irritability in the first few months of life.13,14 However, evidence suggests that acidpeptic or allergic GORD is very rarely a cause of excessive crying or irritability in infants.15,16

Excessive crying, irritability and/or vomiting are non-specific symptoms and may result from other conditions, including food allergy, infections and neurological disease.1

If cows' milk protein allergy or eosinophilic oesophagitis are suspected, refer to a paediatrician. Early identification and treatment of eosinophilic oesophagitis can prevent serious complications that may occur later.2

Normal infant GORGORD
The passage of gastric contents into the oesophagus (with or without regurgitation and vomiting) lasting < 3 minutes in the postprandial period, with few or no symptoms2Troublesome symptoms and/or complications of reflux, such as failure to thrive, haematemesis, refusal to eat, sleeping problems, chronic respiratory disorders, oesophagitis, stricture, anaemia or apnoea, which may appear life threatening2

PPIs not useful for treating symptoms of infant GORD

Infants diagnosed with GORD are often treated with PPIs or other anti-secretory medicines. But a recent systematic review of clinical trials demonstrated that GORD is very rarely a cause of excessive crying or irritability in infants, and PPIs are no better than placebo at relieving symptoms.12 Gastric acid is buffered for 2 hours after feeds of either breast milk or formula, and buffered refluxate is not irritative of oesophageal mucosa.9,17

Advise parents to use conservative treatment (feeding modifications, positioning and avoidance of tobacco smoke) to reduce the risk of reflux in infants.18

Lack of evidence for use of PPIs in infants

PPIs (omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) are used to suppress gastric acid production for conditions such as dyspepsia, GORD, stress ulcer prophylaxis, laryngopharyngeal reflux, duodenal ulceration, and Helicobacter pylori infection.19

The efficacy of PPIs in clinical trials is usually measured against two outcomes — reduction in gastric acidity and symptom reduction. PPIs effectively reduce gastric acid in all age groups, including infants.

However, evidence suggests that PPIs are not effective for infants in relieving the signs and symptoms of GORD traditionally attributed to acid reflux, such as irritablility, crying and fussing.12,20,21

Evidence snapshot

  • A recent systematic review including five placebo-controlled trials in infants aged 1–12 months with GORD concluded that PPIs were not effective in reducing GORD symptoms of feeding-related crying or infant irritability.12
  • In 162 infants aged 1–12 months there was no difference in the efficacy of lansoprazole or placebo in alleviating symptoms attributed to GORD, including; crying, regurgitation, feeding difficulties, back arching, coughing and wheezing.21
  • Clinical trials investigating the effects of esomeprazole and omeprazole on infant irritability and reflux found that, while treatment groups had reduced oesophageal acid exposure, there was no difference in symptoms of irritability or crying.20,22

Potential harms of PPIs in infants

Although short-term use of PPIs appears to be well tolerated, evidence to support long-term safety is lacking.2,12

Little is known about the adverse effects of PPIs in infants. Due to their accepted safety profile in adults, any apparent side effects are often not attributed to the drug.

Most reported adverse effects of PPIs in infants are mild to moderate. They include upper respiratory infection, cough, headache, constipation and diarrhoea.12,23,24

Use of PPIs in infants may increase risk of infection and may be associated with development of allergic disease such as eosinophilic oesophagitis later in life.21,25

Because PPIs are no better than placebo for relieving symptoms of GORD, exposing an infant to even a modest risk of medication side effect is considered inappropriate.12,24

Information for parents

Educating, guiding and supporting parents can help them manage healthy thriving infants with symptoms of uncomplicated reflux.

  • Infant crying generally increases at age 2 weeks, peaks at around 6–8 weeks and usually reduces as infants get older.26
  • Reflux and regurgitation are normal infant behaviours that occur because the infant ingests large quantities of milk relative to their stomach size. Reflux is common and usually uncomplicated, and most symptoms will improve as the infant grows and the digestive system matures.
  • In infants with uncomplicated GOR, consider non-drug options such as:
    • thickening feeds (e.g. with rice cereal, corn starch, guar gum or commercial food thickeners, or using anti-reflux formula) — this may reduce overt regurgitation but not reflux episodes.
    • adopting smaller but more frequent feeding.
    • adjusting sleep position or elevating the head of the cot — placing the baby on their side may reduce reflux but is only appropriate when the baby is awake and closely observed, due to the risk of sudden infant death syndrome.

However, there is little evidence that any of these strategies reduces the frequency of reflux episodes.1

Patient information resources

The Royal Children's Hospital Melbourne: Reflux GOR fact sheet27

Information resources for GPs

  1. Australian Therapeutic Guidelines. Children with gastro-oesophageal reflux. 2013. (accessed 19 July 2013).
  2. Allen K, Ho SS. Gastro-oesophageal reflux in children—what's the worry? Aust Fam Physician 2012;41:268-72. [PubMed]
  3. Hemmi MH, Wolke D, Schneider S. Associations between problems with crying, sleeping and/or feeding in infancy and long-term behavioural outcomes in childhood: a meta-analysis. Arch Dis Child 2011;96:622-9. [PubMed]
  4. Wake M, Morton-Allen E, Poulakis Z, et al. Prevalence, stability, and outcomes of cry-fuss and sleep problems in the first 2 years of life: prospective community-based study. Pediatrics 2006;117:836-42. [PubMed]
  5. Li R, Fein SB, Chen J, et al. Why mothers stop breastfeeding: mothers' self-reported reasons for stopping during the first year. Pediatrics 2008;122 Suppl 2:S69-76. [PubMed]
  6. Odom EC, Li R, Scanlon KS, et al. Reasons for earlier than desired cessation of breastfeeding. Pediatrics 2013;131:e726-32. [PubMed]
  7. Brown M, Heine RG, Jordan B. Health and well-being in school-age children following persistent crying in infancy. J Paediatr Child Health 2009;45:254-62. [PubMed]
  8. Vik T, Grote V, Escribano J, et al. Infantile colic, prolonged crying and maternal postnatal depression. Acta Paediatr 2009;98:1344-8. [PubMed]
  9. Fike FB, Mortellaro VE, Pettiford JN, et al. Diagnosis of gastroesophageal reflux disease in infants. Pediatr Surg Int 2011;27:791-7. [PubMed]
  10. Heine RG, Jordan B, Lubitz L, et al. Clinical predictors of pathological gastro-oesophageal reflux in infants with persistent distress. J Paediatr Child Health 2006;42:134-9. [PubMed]
  11. Fleisher DR. Functional vomiting disorders in infancy: innocent vomiting, nervous vomiting, and infant rumination syndrome. J Pediatr 1994;125:S84-94. [PubMed]
  12. van der Pol RJ, Smits MJ, van Wijk MP, et al. Efficacy of proton-pump inhibitors in children with gastroesophageal reflux disease: a systematic review. Pediatrics 2011;127:925-35. [PubMed]
  13. Barron JJ, Tan H, Spalding J, et al. Proton pump inhibitor utilization patterns in infants. J Pediatr Gastroenterol Nutr 2007;45:421-7. [PubMed]
  14. Diaz DM, Winter HS, Colletti RB, et al. Knowledge, attitudes and practice styles of North American pediatricians regarding gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr 2007;45:56-64. [PubMed]
  15. Hassall E. Over-prescription of acid-suppressing medications in infants: how it came about, why it's wrong, and what to do about it. J Pediatr 2012;160:193-8. [PubMed]
  16. Sherman PM, Hassall E, Fagundes-Neto U, et al. A global, evidence-based consensus on the definition of gastroesophageal reflux disease in the pediatric population. Am J Gastroenterol 2009;104:1278-95; quiz 96. [PubMed]
  17. Orenstein SR, Hassall E. Infants and proton pump inhibitors: tribulations, no trials. J Pediatr Gastroenterol Nutr 2007;45:395-8. [PubMed]
  18. Orenstein SR, McGowan JD. Efficacy of conservative therapy as taught in the primary care setting for symptoms suggesting infant gastroesophageal reflux. J Pediatr 2008;152:310-4. [PubMed]
  19. Mezoff EA, Cohen MB. Acid Suppression and the Risk of Clostridium difficile Infection. J Pediatr 2013. [PubMed]
  20. Davidson G, Wenzl TG, Thomson M, et al. Efficacy and Safety of Once-Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease in Neonatal Patients. J Pediatr 2013. [PubMed]
  21. Orenstein SR, Hassall E, Furmaga-Jablonska W, et al. Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease. J Pediatr 2009;154:514-20 e4. [PubMed]
  22. Omari TI, Haslam RR, Lundborg P, et al. Effect of omeprazole on acid gastroesophageal reflux and gastric acidity in preterm infants with pathological acid reflux. J Pediatr Gastroenterol Nutr 2007;44:41-4. [PubMed]
  23. Hassall E, Kerr W, El-Serag HB. Characteristics of children receiving proton pump inhibitors continuously for up to 11 years duration. J Pediatr 2007;150:262-7, 7 e1. [PubMed]
  24. Chen IL, Gao WY, Johnson AP, et al. Proton pump inhibitor use in infants: FDA reviewer experience. J Pediatr Gastroenterol Nutr 2012;54:8-14. [PubMed]
  25. Merwat SN, Spechler SJ. Might the use of acid-suppressive medications predispose to the development of eosinophilic esophagitis? Am J Gastroenterol 2009;104:1897-902. [PubMed]
  26. Michelsson K, Rinne A, Paajanen S. Crying, feeding and sleeping patterns in 1 to 12-month-old infants. Child Care Health Dev 1990;16:99-111. [PubMed]
  27. The Royal Children's Hospital Melbourne. Reflux GOR 2012. (accessed 5 August 2013).
  28. Australasian Society of Clinical Immunology and Allergy. Health professional information. 2013. (accessed 5 August 2013).
  29. SIDS and kids. Health professional information 2013. (accessed 2 August).