Efficacy and Tolerance of a New Anti-Regurgitation Formula.
10.5223/pghn.2016.19.2.104
- Author:
Christophe DUPONT
1
;
Yvan VANDENPLAS
Author Information
1. Department of Paediatric Gastroenterology Hepatology and Nutrition, Hôpital Necker Enfants Malades, Paris, France.
- Publication Type:Original Article
- Keywords:
Gastroesophageal reflux;
Infant formula
- MeSH:
Dataset;
Gastroesophageal Reflux;
Humans;
Infant;
Infant Formula;
Physiological Phenomena
- From:Pediatric Gastroenterology, Hepatology & Nutrition
2016;19(2):104-109
- CountryRepublic of Korea
- Language:English
-
Abstract:
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±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.