Efficacy and Tolerance of a New Anti-Regurgitation Formula
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Purpose: Regurgitation is a common physiological phenomenon in infants. The aim of the present study was to eval-uate 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 con-sistency were assessed at day 14 and 90. Growth data were recorded at each study visit.Results: Ninety babies (mean age 9.6±5.8 weeks) were included in the full analysis data set. The mean number of regurgitation episodes at inclusion was 7.3±3.4. In all infants, regurgitations improved after 2 weeks. The daily number of regurgitations decreased significantly (−6.3±3.3, p＜0.001) including in those previously fed a thickened formula (−6.2±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±1.0 to −0.1±0.9) and no change of weight-for length z-score (−0.1±1.1 to −0.1±−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.
Abstract
Purpose: Regurgitation is a common physiological phenomenon in infants. The aim of the present study was to eval-uate 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 con-sistency were assessed at day 14 and 90. Growth data were recorded at each study visit.Results: Ninety babies (mean age 9.6±5.8 weeks) were included in the full analysis data set. The mean number of regurgitation episodes at inclusion was 7.3±3.4. In all infants, regurgitations improved after 2 weeks. The daily number of regurgitations decreased significantly (−6.3±3.3, p＜0.001) including in those previously fed a thickened formula (−6.2±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±1.0 to −0.1±0.9) and no change of weight-for length z-score (−0.1±1.1 to −0.1±−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.
참고문헌 (14)
- Vandenplas Y, "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, 49, pp.498~547 (2009)
- Martin AJ, "Natural history and familial relationships of infant spilling to 9 years of age", Pediatrics, 109, pp.1061~1067 (2002)
- Nelson SP, "Prevalence of symptoms of gastroesophageal reflux during infancy. A pediatric practice-based survey. Pediatric Practice Research Group", Arch Pediatr Adolesc Med, 151, pp.569~572 (1997)
- Vandenplas Y, "Prevalence and health outcomes of functional gastrointestinal symptoms in infants from birth to 12 months of age", J Pediatr Gastroenterol Nutr, 61, pp.531~537 (2015)
- Vandenplas Y, "Nutritional management of regurgitation in infants", J Am Coll Nutr, 17, pp.308~316 (1998)
- Vandenplas Y, "Practical algorithms for managing common gastrointestinal symptoms in infants", Nutrition, 29, pp.184~194 (2013)
- Wenzl TG, "Effects of thickened feeding on gastroesophageal reflux in infants: a placebo-controlled crossover study using intraluminal impedance", Pediatrics, 111, pp.e355~e359 (2003)
- Vandenplas Y, "A clinical trial with an "anti-regurgitation" formula", Eur J Pediatr, 153, pp.419~423 (1994)
- Iacono G, "Clinical trial with thickened feeding for treatment of regurgitation in infants", Dig Liver Dis, 34, pp.532~533 (2002)
- Lewis SJ, "Stool form scale as a useful guide to intestinal transit time", Scand J Gastroenterol, 32, pp.920~924 (1997)
- "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" (2006)[URL]
- Horvath A, "The effect of thickened-feed interventions on gastroesophageal reflux in infants: systematic review and meta-analysis of randomized, controlled trials", Pediatrics, 122, pp.e1268~e1277 (2008)
- Vandenplas Y, "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, 173, pp.1209~1216 (2014)
- Dupont C, "Safety of a new amino acid formula in infants allergic to cow’s milk and intolerant to hydrolysates", J Pediatr Gastroenterol Nutr, 61, pp.456~463 (2015)