Inhaled nedocromil sodium in symptomatic young children born prematurely

The efficacy of a non-steroidal anti-inflammatory agent (nedocromil sodium, NS) has been assessed in young children born prematurely who had recurrent respiratory symptoms at follow-up. In a randomized, double-blind cross-over trial, either two puffs of NS (2 mg puff-1) or placebo were administered three times a day via a spacer device and face mask. Fifteen children, median gestational age 27 weeks, birthweight 1100 g and postnatal age 12 months were studied. The symptom score was lower in the last 2 weeks of the active period (median score 26) compared to the run-in period (median score 55) and the last 2 weeks of the placebo period (median score 50), P < 0.01. The maximum possible symptom score for a 2-week period was 210. Compared to the run-in period, children required fewer days of bronchodilator therapy in the last 2 weeks of the active treatment (P < 0.01), but not in the placebo period. Although results of functional residual capacity (FRC) measurements were available on only 13 of the 15 children, these did demonstrate a significant change in FRC over the active, but not the placebo, period. These data suggest that NS is a useful prophylactic agent for children born prematurely and who are symptomatic at follow-up.