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Cromolyn sodium for the prevention of chronic lung disease in preterm infantsNg GY, Ohlsson A
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SummaryCromolyn sodium administered in the first few days of life has not been shown to prevent chronic lung disease in preterm infantsPreterm babies (babies born before 37 weeks gestation) often need to be given oxygen for lung problems for many weeks because of chronic lung disease. This is due, in part, to inflammation (swelling) within the lungs. Theoretically, cromolyn sodium is a drug that might help prevent this inflammation. It is relatively safe and adverse effects are rare. It can be given by nebuliser or aerosol inhaler in the first few days, in an attempt to prevent chronic lung disease. However, the review of trials found no strong evidence that cromolyn sodium can prevent or reduce chronic lung disease and further research does not seem to be justified.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2008 Issue 3, Copyright © 2008 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
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April 23. 2001 AbstractBackgroundChronic lung disease (CLD) frequently occurs in preterm infants (< 37 weeks gestational age) and has a multifactorial etiology including inflammation. Cromolyn sodium is a mast cell stabiliser that inhibits neutrophil activation and neutrophil chemotaxis. Therefore, it is possible that cromolyn sodium might have a role in the prevention of CLD. ObjectivesTo assess the effect of prophylactic administration of cromolyn sodium on the incidence of CLD, mortality or the combined outcome of mortality or CLD at 28 days of life, in preterm infants. Search strategyThe search strategy of the Cochrane Neonatal Review Group was used to identify studies. Searches were made of MEDLINE, EMBASE, CINAHL up to and including April 2006, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2006), personal files and reference lists of identified trials. Selection criteriaRandomised or quasi-randomised controlled clinical trials involving preterm infants. Initiation of cromolyn sodium administration during the first two weeks of life. The intervention had to include administration of cromolyn sodium by nebulizer or metered dose inhaler with or without spacer device, versus placebo or no intervention. Eligible studies had to include at least one of the following outcomes: overall mortality, CLD at 28 days, CLD at 36 weeks postmenstrual age, or the combined outcome mortality or CLD at 28 days. Secondary outcomes included number of days on oxygen, number of days on mechanical ventilation, patent ductus arteriosus (PDA), air leaks [pulmonary interstitial emphysema (PIE), pneumothorax], any grade of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), sepsis and adverse effects due to cromolyn sodium. Data collection and analysisThe standard method for the Cochrane Collaboration as described in the Cochrane Collaboration handbook was used. Both investigators extracted and assessed all data for each study. Any disagreement was resolved by discussion. Relative risk (RR) and risk difference (RD) with 95% confidence intervals (CI) are reported for dichotomous outcomes and weighted mean difference (WMD) for continuous data. Number needed to treat was not calculated since no outcome showed a statistically significant RD. A fixed effect model was used for meta-analysis. Heterogeneity was examined using the I2 statistic. Main resultsTwo eligible studies were identified with small numbers of infants enrolled. Prophylaxis with cromolyn sodium did not result in a statistically significant effect on the combined outcome, death or CLD at 28 days [typical RR 1.05 (95% CI 0.73, 1.52); typical RD 0.03 (95% CI -0.20, 0.27)], CLD at 28 days [typical RR 0.93 (95% CI 0.53, 1.64; typical RD -0.03 (95% CI -0.27, 0.20)], CLD at 36 weeks postmenstrual age [RR 1.25 (95% CI 0.43, 3.63); RD 0.08 (95% CI -0.29, 0.44)], CLD in survivors at 28 days [typical RR 0.97 (95% CI 0.58, 1.63); typical RD -0.02 (95% CI -0.29, 0.26)] or CLD in survivors at 36 weeks postmenstrual age [RR 1.04 (95% CI 0.38, 2.87); RD 0.02 (95% CI -0.40, 0.43)]. Prophylaxis with cromolyn sodium did not show a statistically significant difference in overall neonatal mortality [typical RR 1.31 (95% CI 0.52, 3.29); typical RD 0.06 (95% CI -0.13, 0.26)]. There were no statistically significant differences in the incidence of air leaks, NEC, IVH, sepsis, days on mechanical ventilation or PDA. No side effects were noted. Authors' conclusionsThere is currently no evidence from randomized trials that cromolyn sodium has a role in the prevention of CLD. Cromolyn sodium cannot be recommended for the prevention of CLD in preterm infants. Additional clinical trials do not appear to be justified using the protocols for drug administration that are presently used, unless a more efficient type of delivery device than the jet nebulizer is employed. |