DOI QR코드

DOI QR Code

Efficacy and Tolerance of a New Anti-Regurgitation Formula

  • 투고 : 2016.01.20
  • 심사 : 2016.02.29
  • 발행 : 2016.06.30

초록

Purpose: Regurgitation is a common physiological phenomenon in infants. The aim of the present study was to evaluate the efficacy of a new anti-regurgitation (AR) formula (Novalac), thickened with an innovative complex including fibres, on the daily number of regurgitations and to assess its impact on stool consistency and frequency. Methods: Infants younger than five months, presenting at least 5 regurgitations per day were recruited in this trial. The efficacy of the new formula on regurgitation (daily number and Vandenplas score), stool frequency and consistency were assessed at day 14 and 90. Growth data were recorded at each study visit. Results: Ninety babies (mean age $9.6{\pm}5.8weeks$) were included in the full analysis data set. The mean number of regurgitation episodes at inclusion was $7.3{\pm}3.4$. In all infants, regurgitations improved after 2 weeks. The daily number of regurgitations decreased significantly ($-6.3{\pm}3.3$, p<0.001) including in those previously fed a thickened formula ($-6.2{\pm}3.0$, p<0.001). There was no significant change in stool consistency at day 14. After 3 months, 97.5% of infants had formed or soft stools. Growth was appropriate with a slight increase of weight-for-age z-score (from $-0.5{\pm}1.0$ to $-0.1{\pm}0.9$) and no change of weight-for length z-score ($-0.1{\pm}1.1$ to $-0.1{\pm}-1.1$). Conclusion: The new AR formula thickened with an innovative complex is very effective in reducing the daily number of regurgitations without having a negative impact on stools consistency.

키워드

참고문헌

  1. Vandenplas Y, Rudolph CD, Di Lorenzo C, Hassall E, Liptak G, Mazur L, et al. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr 2009;49:498-547. https://doi.org/10.1097/01.mpg.0000361306.15727.54
  2. Martin AJ, Pratt N, Kennedy JD, Ryan P, Ruffin RE, Miles H, et al. Natural history and familial relationships of infant spilling to 9 years of age. Pediatrics 2002;109:1061-7. https://doi.org/10.1542/peds.109.6.1061
  3. Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during infancy. A pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med 1997;151:569-72. https://doi.org/10.1001/archpedi.1997.02170430035007
  4. Vandenplas Y, Abkari A, Bellaiche M, Benninga M, Chouraqui JP, Cokura F, et al. Prevalence and health outcomes of functional gastrointestinal symptoms in infants from birth to 12 months of age. J Pediatr Gastroenterol Nutr 2015;61:531-7. https://doi.org/10.1097/MPG.0000000000000949
  5. Vandenplas Y, Lifshitz JZ, Orenstein S, Lifschitz CH, Shepherd RW, Casaubon PR, et al. Nutritional management of regurgitation in infants. J Am Coll Nutr 1998;17:308-16. https://doi.org/10.1080/07315724.1998.10718767
  6. Vandenplas Y, Gutierrez-Castrellon P, Velasco-Benitez C, Palacios J, Jaen D, Ribeiro H, et al. Practical algorithms for managing common gastrointestinal symptoms in infants. Nutrition 2013;29:184-94. https://doi.org/10.1016/j.nut.2012.08.008
  7. Wenzl TG, Schneider S, Scheele F, Silny J, Heimann G, Skopnik H. Effects of thickened feeding on gastroesophageal reflux in infants: a placebo-controlled crossover study using intraluminal impedance. Pediatrics 2003;111:e355-9. https://doi.org/10.1542/peds.111.4.e355
  8. Vandenplas Y, Hachimi-Idrissi S, Casteels A, Mahler T, Loeb H. A clinical trial with an "anti-regurgitation" formula. Eur J Pediatr 1994;153:419-23.
  9. Iacono G, Vetrano S, Cataldo F, Ziino O, Russo A, Lorello D, et al. Clinical trial with thickened feeding for treatment of regurgitation in infants. Dig Liver Dis 2002;34:532-3.
  10. Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol 1997;32:920-4. https://doi.org/10.3109/00365529709011203
  11. World Health Organization.WHO Multicentre Growth Reference Study Group: WHO Child Growth Standards: length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: methods and development. Geneva: World Health Organization; 2006. Available from: http://www.who.int/childgrowth/standards/en/.
  12. Horvath A, Dziechciarz P, Szajewska H. The effect of thickened-feed interventions on gastroesophageal reflux in infants: systematic review and meta-analysis of randomized, controlled trials. Pediatrics 2008;122: e1268-77. https://doi.org/10.1542/peds.2008-1900
  13. Vandenplas Y, De Greef E, Hauser B; Paradice Study Group. Safety and tolerance of a new extensively hydrolyzed rice protein-based formula in the management of infants with cow's milk protein allergy. Eur J Pediatr 2014;173:1209-16. https://doi.org/10.1007/s00431-014-2308-4
  14. Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, et al. Safety of a new amino acid formula in infants allergic to cow's milk and intolerant to hydrolysates. J Pediatr Gastroenterol Nutr 2015;61: 456-63. https://doi.org/10.1097/MPG.0000000000000803

피인용 문헌

  1. Hypoallergenicity of a thickened hydrolyzed formula in children with cow’s milk allergy vol.7, pp.16, 2016, https://doi.org/10.12998/wjcc.v7.i16.2256
  2. Different thickening complexes with pectin in infant anti‐regurgitation formula vol.109, pp.3, 2020, https://doi.org/10.1111/apa.15015
  3. Effectiveness and Tolerance of a Locust Bean Gum-Thickened Formula: A Real-Life Study vol.23, pp.6, 2016, https://doi.org/10.5223/pghn.2020.23.6.511
  4. Opinion on the re‐evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives in foods for infants below 16 weeks of age and follow‐up of their re‐evaluation as vol.19, pp.1, 2016, https://doi.org/10.2903/j.efsa.2021.6387