21 research outputs found

    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.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
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