Comparison of the effect of a cornstarch thickened formula and strengthened regular formula on regurgitation, gastric emptying and weight gain in infantile regurgitation.

The purpose of this study was to evaluate the efficacy of a specially selected cornstarch-supplemented formula on clinical symptoms, gastric emptying and weight gain in infants with regurgitation. We performed a prospective randomised trial evaluating the therapeutic efficacy of two different formula feedings (cornstarch-thickened formula, group A; 25% strengthened formula, group B) in 81 young infants with regurgitation/vomiting > or = 3 times/day. A Tc-99 m milk scintigraphy was performed at inclusion and after 2 months to quantify gastric emptying time; all studied infants underwent a 2-month period of clinical follow-up evaluating regurgitation and body weight gain. At inclusion, group A and B had a similar age and weight. After the 2-month period of intervention, regurgitation and vomiting had both greater decrease (both P < 0.001 at 1 and 2 months) in group A (from a score of 4.19 +/- 1.71 to 0.93 +/- 0.42) than in group B (from a score of 4.15 +/- 1.68 to 2.89 +/- 1.16). Non-regurgitation symptoms (irritability, cough, choking, night-waking) decreased (P = 0.045 at 1 month and 0.017 at 2 months) in group A (from a score of 18 at baseline to 3 after 8 weeks) as compared to group B (from a score of 18 at baseline to 11 after 8 weeks). Weight increased more in group A (29.1 +/- 3.9 g/day over 8 weeks) versus group B (23.6 +/- 3.5 g/day over 8 weeks) (P < 0.01 at 1 and 2 months) Gastric emptying improved significantly in group A as compared with group B (all P < 0.001 for T1/2, and residual volume at 60 and 90 min). Ingested feeding volume was significantly larger in the group receiving cornstarch-thickened formula, both at 4 weeks (109.4 +/- 24.5 vs. 98.5 +/- 23.6 mL/meal) (P: 0.042) and at 8 weeks (137.6 +/- 27.9 vs. 115.7 +/- 26.5 mL/meal) (P < 0.001). Cornstarch-thickened formula feeding decreases the frequency of regurgitation/vomiting, provides better body weight gain and has an accelerated gastric emptying in comparison to a 25% strengthened regular formula in infants with regurgitation.

RCT Entities:   Population Interventions Outcomes