Pediatr Gastroenterol Hepatol Nutr.  2016 Jun;19(2):104-109. 10.5223/pghn.2016.19.2.104.

Efficacy and Tolerance of a New Anti-Regurgitation Formula

• Dupont C
• Vandenplas Y
• SONAR Study Group

• KMID: 2328170
• DOI: http://doi.org/10.5223/pghn.2016.19.2.104

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.

Keyword

Gastroesophageal reflux; Infant formula

MeSH Terms

Dataset
Gastroesophageal Reflux
Humans
Infant
Infant Formula
Physiological Phenomena

Figure

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  Fig. 1 Flow diagram.

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  Fig. 2 Evolution of the daily mean number of regurgitations and Vandenplas score from inclusion to 14 days.

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  Fig. 3 Evolution of the weight for age z-score.

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