Efficacy of a Pre-thickened Infant Formula: A Multicenter,Double-Blid,Randomized,Placebo-Controlled Parallel Group Trial in 104 Infants with Symptomatic Gastroesophageal Reflux
Restricted accessResearch articleFirst published online July, 2003
Efficacy of a Pre-thickened Infant Formula: A Multicenter,Double-Blid,Randomized,Placebo-Controlled Parallel Group Trial in 104 Infants with Symptomatic Gastroesophageal Reflux
To evaluate a pre-thickened formula (Enfamil AR1/2) for regurgitant gastroesophageal reflux, 104 infants were enrolled in a 5-week, multi center, double-blind, randomized, place bo controlled parallel group trial. The Enfamil AR group showed greater symptom reduction by the end of the first week: percent feedings with any regurgitation (p=0.045), total regurgitation volume score (p=0.035), and percent feedings with choke-gag-cough (p=0.004). The most symptomatic infants at baseline had a reduction in trouble sleeping significantly with Enfamil AR by the end of the study (p=0.030). This formula flows through a standard nipple, reduces regurgitation and choking-gagging-coughing within a week, and improves sleep in the most symptomatic babies by 5 weeks, without causing constipation.
Get full access to this article
View all access options for this article.
References
1.
1. Orenstein S, Shalaby T, Cohn J.Reflux symptoms in 100 normal infants: diagnostic validity of the Infant Gastroesophageal Reflux Questionnaire. Clin Pediatr1996;35:607-614.
2.
2. Nelson SP, Chen EH, Syniar GM, Christoffel KK, the Pediatric Practice Research Group. Prevalence of symptoms of gastroesophageal reflux during infancy: a pediatric practice-based survey. Arch Pediatr Adolesc Med. 1997;151:569-572.
3.
3. Sutphen JL, Dillard VL. Effect of feeding volume on early postcibal gastroesophageal reflux in infants. J Pediatr Gastroenterol Nutr1988;7:185-188.
4.
4. Sutphen JL, Dillard VL. Dietary caloric density and osmolality influence gastroesophageal reflux in infants. Gastroenterology. 1989;97:601-604.
5.
5. Siegal M, Krantz, B, Lebenthal E.Effect of fat and carbohydrate composition on the gastric emptying of isocaloric feedings in premature infants. Gastroenterology. 1985;89:785-790.
6.
6. Rudolph CD, Mazur LJ, Liptak GS, et al. Guidelines for evaluation and treatment of gastroesophageal reflux in infants and children. J Pediatr Gastroenterol Nutr2001;32:S1-S31.
7.
7. Vandenplas Y.Current concepts and issues in the management of regurgitation of infants: a reappraisal. Management guidelines from a working party. Acta Paediatr1996;85:531-534.
8.
8. Vandenplas Y, Ashkenazi A, Belli D, et al. A proposition for the diagnosis and treatment of gastro-oesophageal reflux disease in children: a report from a working group on gastrooesophageal reflux disease. Eur J Pediatr. 1993;157:704-711.
9.
9. Shalaby TM, Orenstein SR. Efficacy of conservative therapy in infants with gastroesophageal reflux disease referred by pediatricians to pediatric gastroenterologists. Gastroenterology. 2001;120:A49-A49.
10.
10. Carroll A, Garrison M, Christakis D.A systematic review of nonpharmacological and nonsurgical therapies for gastroesophageal reflux in infants. Arch Pediatr Adolesc Med. 2002;156:109-113.
11.
11. Orenstein SR, Magill HL, Brooks P.Thickening of infant feedings for therapy of gastroesophageal reflux. J Pediatr1987;110:181-186.
12.
12. Carre W.Management of gastro-oe-sophageal reflux. Arch Dis Child. 1985;60:71-75.
13.
13. Vandenplas Y, Sacre L.Milk-thickening agents as a treatment for gastroesophageal reflux. Clin Pediatr. 1987;26:66-68.
14.
14. Greally P, Hampton FJ, Mac Fadyen UM, Simpson H.Gaviscon and Carobel compared with cisapride in gastrooesophageal reflux. Arch Dis Child. 1992;67:618-621.
15.
15. Borrelli O, Slavia G, Campanozzi A, et al. Use of a new thickened formula for the treatment of symptomatic gastrooesophageal reflux in infants. Ital J Gastroenterol Hepatol. 1997;29:237-242.
16.
16. Bosscher D, Van Caille-Bertrand M, Van Dyck K, Robberecht H, Van Cauwenbergh R, Deelstra H.Thickening infant formula with digestible and indigestible carbohydrate: availability of cacitum, iron, and zinc in vitro. J Pediatr Gastroenterol Nutr. 2000;30:373-378.
17.
17. Savino F, Muratore M, Silvestro L, Oggero R, Mostert M.Allergy to carob gum in an infant. J Pediatr Gastroenterol Nutr1999;29:475-476.
18.
18. Berenberg W, Neuhauser EBD. Cardio-esophageal relaxation (chalasia) as a cause of vomiting in infants. Pediatrics. 1950;5:414-420.
19.
19. Carre IJ. Postural treatment of children with a partial thoracic stomach ("hiatal hernia"). Arch Dis Child. 1960;35:569-580.
20.
20. Carre IJ. The Therapeutic and Diagnostic V4alue of Thickened Milk Feeds in Vomiting Babies. In International Congress of Pediatrics, 11th. Tokyo: University of Tokyo Press, 1965.
21.
21. Bailey DJ, Andres JM, Danek GD, Pineiro CVM. Lack of efficacy of thickened feeding as treatment for gastroesophageal reflux. J Pediatr. 1987;110:187-189.
22.
22. Vandenplas Y, Hachimi-Idrissi S, Casteels A, Mahler T, Loeb H.A clinical trial with an "antiregurgitation" formula. Eur J Pediate1994;153:419-423.
23.
23. Baldassarre M, Franco MT, Crudele A, et al. Effetto di una formula ad elevata viscosita (Enfamil pre-gel, Mead Johnson) nel lattante con reflusso gastroesofageo sintomatico. Riv Ital Pediatr2001;27:137-141.
24.
24. Moran JR, Mehra S, Kalhan SC, Harris CL, Merkel KL. Growth of term infants receiving a prethickened formula. Pediatr Res. 1999;45:114A-114A.
25.
25. Tolia V, Wuerth A, Shashidhar HS, Peters JM, Lin CH. A prospective study with an antiregurgitation (AR) formula in infants with gastroesophageal reflux (GER) symptoms. Gastrointest Endosc. 1999;49:AB186-AB189.
26.
26. Kazlow P, Deckelbaum RJ. Gastroesophageal reflux: lessons from children (selected summaries). Gastroenterology. 1988;94:1231-1232.
27.
27. Prather CM, Thomforde GM, Camilleri M.Increased viscosity accelerates gastric emptying of liquids and solid particles by stimulating proximal antral motility. Gastroenterology. 1992;103:1377-1377.
28.
28. Cichero JAY, Jackson O, Halley PJ, Murdoch BE. How thick is thick? Multicenter study of the rheological and material property characteristics of mealtime fluids and videofluoroscopy fluids. Dysphagia. 2000;15:188-200.
29.
29. Khoshoo V, Ross G, Brown S, Edell D.Smaller volume, thickened formulas in the management of gastroesophageal reflux in thriving infants. J Pediatr Gastroenterol Nutr. 2000;31:554-556.
30.
30. Ramenofsky ML, Leape LL. Continuous upper esophageal p H monitoringin infants and children with gastroesophageal reflux, pneumonia, and apneic spells.J Pediatr Surg. 1981;16:374-378.
31.
31. Shulman R, Boutton T, Klein P.Impactof dietary cereal on nutrient absorption and fecal nitrogen loss in formulafed infants.J Pediatr1991;118:39-43.
32.
32. Lifschitz C, Torun B, Chew F, Boutton T, Garza C, Klein P.Absorption of carbon 13-labeled rice in milk by infants during acute gastroenteritis. J Pediatr1991;118:526-530.
33.
33. Kramer MS, Barr RG, Leduc DG, Boisjoly C, Mc Vey-White L, Pless IB. Determinants of weight and adiposity in the first year of life. J Pediatr. 1985;106:10-14.
34.
34. Dantas RO, Dodds WJ, Massey BT, Kern MK. The effect of highvs lowdensity barium preparations on the quantitative features of swallowing. AJR1989;153:1191-1195.
35.
35. Li M, Brasseur J, Kern M, Dodds W.Viscosity measurements of barium sulfate mixtures for use in motility studies of the pharynx and esophagus. Dysphagia. 1992;7:17-30.
36.
36. Orenstein SR, Shalaby TM, Putnam PE. Thickened feedings as a cause of increased coughing when used as therapy for gastroesophageal reflux in infants.J Pediatr1992;121:913-915.
37.
37. Orenstein S, Shalaby T, Orenstein D, Putnam P.Thickening of feedings with rice cereal to treat infantile regurgitation does not increase coughing in infants with respiratory disease. Gastroenterology. 1994;106:A153-A153.
38.
38. Khoshoo V, Ross G, Kelly B, Edell D, Brown S.Benefits of thickened feeds in previously healthy infants with respiratory syncytial viral bronchiolitis. Pediatr Pulmonol. 2001;31:301-302.
39.
39. Keane K, Charney E, Straus J, Roberts K.Do solids help baby sleep through the night? (abstr). Am J Dis Child. 1988;142:404-405.
40.
40. Macknin ML, Vander Brug Medendorp S.Infant sleep and bedtime cereal. Am J Dis Child. 1989;143:1066-1068.
41.
41. Ghaem M, Armstrong K, Trocki O, Cleghorn G, Patrick M, Shepherd R.The sleep patterns of infants and young children with gastro-oe-sophageal reflux. J Paediatr Child Health. 1998;34:160-163.
42.
42. De Vizia B, Ciccimarra F, De Cicco N, Auricchio S.Digestibility of starches in infants and children. J Pediatr. 1975;86:50-55.
