Effect of antireflux medication, placebo and infant mental health intervention on persistent crying: a randomized clinical trial.

To assess the effect of medical antireflux treatment, and of an infant mental health consultation (IMHC), on persistent crying in infants and maternal distress. Infants under 9 months of age with persistent crying, and their mothers, were enrolled in a randomized placebo-controlled trial. At enrollment, a questionnaire on demographic and clinical details was completed by mothers, and maternal distress was measured (Experience of Motherhood Questionnaire; EMQ). Oesophageal 24-h pH monitoring was performed in all infants on day 2. At week 4, the cry chart and EMQ were repeated in conjunction with a final interview. One hundred and three infants (56 under 3 months of age; 55 male) who were randomized to active medication (ranitidine plus cisapride; n = 34), placebo (n = 29) or IMHC (n = 40) completed the trial. There was a significant reduction in crying duration from baseline to week 4 (253 +/- 96.5 min vs 159 +/- 92.3 min per 24 h; P < 0.001), without differences between treatment groups (AVOVA: F = 0.75; P = 0.48). There was a modest improvement in EMQ scores from 44.9 +/- 8.6 at day 1 to 42.8 +/- 9.4 at week 4; P = 0.006. The improvement in maternal stress was similar in all treatment groups (Kruskal-Wallis chi2 = 0.354; P = 0.84), but subsequent admission to a mother-infant unit was significantly less frequent in the IMHC group (P < 0.05). Antireflux medications and IMHC were not superior to placebo in treating infants with persistent crying. Although the reduction in maternal distress was similar in all treatment groups, the individualized IMHC reduced the need for subsequent admission to a mother-infant unit.