American Academy of Pediatrics – Section on Perinatal Pediatrics

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Released July 20, 2015

Avoid routine use of anti-reflux medications for treatment of symptomatic gastroesophageal reflux disease (GERD) or for treatment of apnea and desaturation in preterm infants.

Gastroesophageal reflux is normal in infants. There is minimal evidence that reflux causes apnea and desaturation. Similarly, there is little scientific support for the use of H2 antagonists, proton-pump inhibitors, and motility agents for the treatment of symptomatic reflux. Importantly, several studies show that their use may have adverse physiologic effects as well as an association with necrotizing enterocolitis, infection and, possibly, intraventricular hemorrhage and mortality.

These items are provided solely for informational purposes and are not intended as a substitute for consultation with a medical professional. Patients with any specific questions about the items on this list or their individual situation should consult their physician.

How The List Was Created

The American Academy of Pediatrics Section on Perinatal Pediatrics (SoPPe) Executive Committee employed a national survey of representative newborn medicine providers from SoPPe and the Vermont-Oxford Network. Survey recipients were asked to consider the range of testing and treatments conducted on high and low risk newborns. They were then asked them to provide examples of tests and treatments that, in their opinion, best met any or all of the following criteria: there is evidence of lack of efficacy, there is insufficient evidence of efficacy, or the test or treatment unnecessarily utilized staffing or material resources. Among the recipients, 1047 responded with a total of 2870 suggestions of tests and treatments. These responses were then collated and presented to an expert panel of 51 individuals representing 28 national and regional stakeholder perinatal care organizations. A modified Delphi process utilizing electronic survey techniques was used to narrow the list to the Top 5 over three rounds. During the initial round, the panel reduced the top 22 general categories of tests and treatments to 13. The reintroduction of specific clinical contexts, derived from the original survey, resulted in 24 items that were reduced to 12 in the second round. In the final round, the panel was provided with GRADE (Grades of Recommendation, Assessment, Development and Evaluation) literature summaries of the top 12 to ensure that all current evidence was considered. The final list was reviewed and approved by the Academy’s Board of Directors and Executive Committee.

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Bianconi S, Gudavalli M, Sutija VG, Lopez AL, Barillas-Arias L, Ron N. Ranitidine and late-onset sepsis in the neonatal intensive care unit. J Perinat Med. 2007; 35(2):147–50.

Chung EY, Yardley J. Are there risks associated with empiric acid suppression treatment of infants and children suspected of having gastroesophageal reflux disease? Hosp Pediatr. 2013 Jan;3(1):16-23.

Guillet R, Stoll BJ, Cotten CM, Gantz M, McDonald S, Poole WK, Phelps DL; National Institute of Child Health and Human Development Neonatal Research Network. Association of H2-blocker therapy and higher incidence of necrotizing enterocolitis in very low birth weight infants. Pediatrics. 2006 Feb;117(2):e137-42.

Hibbs AM, Lorch SA. Metoclopramide for the treatment of gastroesophageal reflux disease in infants: a systematic review. Pediatrics. 2006 Aug;118(2):746-52.

Rojas MA, Efird MM, Lozano JM, Bose CL, Rojas MX, Rondón MA, Ruiz G, Piñeros JG, Rojas C, Robayo G, Hoyos A, Gosendi MH, Cruz H, O’Shea M, Leon A. Risk factors for nosocomial infections in selected neonatal intensive care units in Colombia, South America. J Perinatol. 2005 Aug;25(8):537–41.

Terrin G, Passariello A, De Curtis M, Manguso F, Salvia G, Lega L, Messina F, Paludetto R, Canani RB. Ranitidine is associated with infections, necrotizing enterocolitis, and fatal outcome in newborns. Pediatrics. 2012 Jan;129(1):e40-5.

van der Pol RJ, Smits MJ, van Wijk MP, Omari TI, Tabbers MM, Benninga MA. Efficacy of proton-pump inhibitors in children with gastroesophageal reflux disease: a systematic review. Pediatrics. 2011 May;127(5):925-35.

Wheatley E, Kennedy KA. Cross-over trial of treatment for bradycardia attributed to gastroesophageal reflux in preterm infants. J Pediatrics. 2009 Oct;155(4):516-21.