BACKGROUND:Regurgitation is frequent in infants. We evaluated changes in regurgitation among patient groups fed standard formula, standard formula subsequently thickened with cereal, or formula manufactured with bean gum as a thickening agent. PATIENTS AND METHODS: A prospective, blinded, randomised 1-month intervention trial evaluating the efficacy of parental reassurance of the regurgitating child in combination with 3 formula interventions--standard infant formula (group A); 5 g of rice cereal added to 100 mL standard formula (group B); and formula manufactured with bean gum as a thickening agent (group C)--was performed in 60 infants presenting with more than 4 episodes of regurgitation and/or vomiting per day during the week before inclusion. Formula intake, infant comfort, stool aspects, and weight gain were evaluated. All of the infants and data recorded by parents in a diary were evaluated weekly by a blinded health care professional. RESULTS: At baseline, groups A, B, and C were similar for all of the parameters. After the 1-month intervention, regurgitation/vomiting decreased significantly in all 3 groups (P < 0.0005). Although the decrease was largest in group C (-4.2 +/- 2.1 episodes/day), the incidence did not differ significantly with groups A or B. At no evaluation interval was there a difference in volume of formula intake, infant comfort, stool frequency, or aspect. After 1 month, weight gain was significantly greater in group C compared with group A (19.9% vs 16.4%; P < 0.001). CONCLUSIONS:Thickening of formula decreases regurgitation, but not significantly. Parental reassurance remains the cornerstone of the treatment of infant regurgitation.
RCT Entities:
BACKGROUND: Regurgitation is frequent in infants. We evaluated changes in regurgitation among patient groups fed standard formula, standard formula subsequently thickened with cereal, or formula manufactured with bean gum as a thickening agent. PATIENTS AND METHODS: A prospective, blinded, randomised 1-month intervention trial evaluating the efficacy of parental reassurance of the regurgitating child in combination with 3 formula interventions--standard infant formula (group A); 5 g of rice cereal added to 100 mL standard formula (group B); and formula manufactured with bean gum as a thickening agent (group C)--was performed in 60 infants presenting with more than 4 episodes of regurgitation and/or vomiting per day during the week before inclusion. Formula intake, infant comfort, stool aspects, and weight gain were evaluated. All of the infants and data recorded by parents in a diary were evaluated weekly by a blinded health care professional. RESULTS: At baseline, groups A, B, and C were similar for all of the parameters. After the 1-month intervention, regurgitation/vomiting decreased significantly in all 3 groups (P < 0.0005). Although the decrease was largest in group C (-4.2 +/- 2.1 episodes/day), the incidence did not differ significantly with groups A or B. At no evaluation interval was there a difference in volume of formula intake, infant comfort, stool frequency, or aspect. After 1 month, weight gain was significantly greater in group C compared with group A (19.9% vs 16.4%; P < 0.001). CONCLUSIONS: Thickening of formula decreases regurgitation, but not significantly. Parental reassurance remains the cornerstone of the treatment of infant regurgitation.