Early indicators of chronic lung disease in preterm infants with respiratory distress syndrome and their inhibition by melatonin.
Level 2 - randomized trial
Controlled clinical trial with parallel control group
PubMed 15066049 · doi:10.1111/j.1600-079X.2004.00124.x
What was done
In a controlled clinical trial, 120 newborns diagnosed with respiratory distress syndrome (RDS) were allocated to either melatonin treatment (60 infants) or placebo (60 infants). Researchers evaluated serum concentrations of proinflammatory cytokines (IL-6, IL-8, TNF-alpha) and nitrite/nitrate levels, alongside incidence of chronic lung disease (CLD) and mortality.
What was found
Melatonin administration reduced serum levels of IL-6, IL-8, TNF-alpha, and nitrite/nitrate relative to placebo, though the abstract provides no specific numerical values, variances, or p-values. Eight infants in the non-melatonin group developed CLD and showed higher cytokine and nitrite/nitrate levels than those without CLD. Two infants in the control group died versus zero in the melatonin group. Melatonin was reported to be well tolerated.
Why it matters
This trial suggests that melatonin administration may downregulate systemic inflammatory and nitrosative stress markers in preterm infants with RDS, potentially lowering risks of chronic lung disease.
Limits
The abstract reports no numerical data, confidence intervals, or statistical test statistics. Details concerning randomization method, allocation concealment, and blinding are unspecified in the abstract. Clinical outcome counts were very low (eight cases of CLD, two deaths), and long-term neurodevelopmental safety was not evaluated.
Cited by
- supports Two clinical studies showed that melatonin has antioxidant and anti-inflammatory actions in newborns with respiratory distress syndrome, reducing pro-inflammatory cytokines and improving clinical outcomes.