The effect of sodium cromoglycate on upper and lower respiratory symptoms in children born prematurely.

The aims of this study were to assess whether sodium cromoglycate (SCG) was an effective prophylaxis against both upper and lower respiratory tract signs and to determine factors which affected the site and magnitude of the response to SCG. Sixteen children born prematurely were entered into a randomised placebo-controlled trial at 15 months of age (range 4-31 months). The patients received, in random order, either 3 weeks' treatment with SCG (5 mg) or placebo, both given four times a day by inhalation via a spacer device. Parents were asked to record the occurrence and severity of their child's upper respiratory tract signs; sneezing and runny nose and lower respiratory tract signs; day and night time cough and wheeze. During the active compared to the placebo period there was an overall reduction of 47% and 53% in upper and lower respiratory tract signs, respectively. The magnitude of response to SCG as assessed by either the change in upper or lower respiratory tract signs was not significantly related to the patient's gestational or postnatal age, the occurrence of neonatal chronic lung disease, family history of atopy or the order in which the therapy was administered. We conclude that inhaled SCG may be a useful prophylaxis for both upper and lower respiratory tract signs for children born prematurely and less than 3 years of age.

RCT Entities:   Population Interventions Outcomes