Table 1.

Summary of the four RCTs examining the efficacy of PPI therapy in infants with GERD

Parameter	Esomeprazole28	Lansoprazole29	Pantoprazole30	Omeprazole31
Control group	Placebo	Placebo	Placebo	Dosing range
Blinding	Double	Double	Double	Single
Length of randomized phase in weeks	4	4	4	8
Open-label phase to identify PPI responders	Yes (2 weeks)	No	Yes (4 weeks)	No
Age in months	1–12	1–12	1–12	0–24
N	40	80	50	35
GERD symptoms definition	Vomiting Regurgitation Irritability Supraesophageal disturbance Respiratory disturbance Feeding difficulty	Crying Fussiness Irritability	Vomiting Regurgitation Spitting up Irritability Fussiness Feeding refusal Choking Gagging	Vomiting Regurgitation
Primary end point	Time from randomization to discontinuation due to symptom worsening, perceived by parent and physician	Proportion of infants with ≥50% reduction in Physician Global Assessment of GERD-related symptoms	Proportion of infants who withdrew due to “lack of efficacy,” perceived by physician and/or worsening esophagitis on endoscopy	Change from baseline in daily symptoms based on Physician Global Assessment and parent perception
Primary end point efficacy result	Hazard ratio = 0.69 95% CI [0.35–1.35] P = 0.275	PPI: 54% Placebo: 54% P = 1.000	PPI: 12% Placebo: 11% P = 1.000	P > 0.50 in all dosing-group comparisons

CI, confidence interval; GERD, gastroesophageal reflux disease; PPI, proton pump inhibitor; RCT, randomized controlled trial.

Data from refs. 27–31.