Gitto · American journal of perinatology 2004 · Placebo-controlled clinical trial · n=?

Oxidative and inflammatory parameters in respiratory distress syndrome of preterm newborns: beneficial effects of melatonin.

Cited 163 times in the scientific literature.

Level 2 - randomized trial

Placebo-controlled clinical trial evaluating a pharmacological intervention.

PubMed 15168319 · doi:10.1055/s-2004-828610 · record verified 2026-08-30

What was done

Preterm newborns with radiographically confirmed grade III or IV respiratory distress syndrome (RDS) diagnosed within the first 6 hours of life were assigned to receive treatment with either the antioxidant melatonin or a placebo. Blood samples were collected prior to treatment (from umbilical cord or peripheral vein) and at 24 hours, 72 hours, and 7 days after starting treatment to measure inflammatory cytokines (interleukin-6, interleukin-8, tumor necrosis factor alpha) and oxidative stress markers (nitrite/nitrate levels).

What was found

The abstract does not provide numerical values, sample sizes, or p-values. It reports that compared to melatonin-treated infants, untreated infants had significantly higher concentrations of IL-6, IL-8, and TNF-alpha at 24 hours, 72 hours, and 7 days. Nitrite/nitrate levels were also higher at all time points in untreated infants and continued to rise, whereas levels decreased significantly following melatonin treatment.

Why it matters

This study provides evidence that melatonin may attenuate systemic inflammation and reactive nitrogen/oxygen species pathways in severe neonatal respiratory distress syndrome.

Limits

The abstract omits total sample size, participant baseline characteristics, exact biomarker concentrations, effect sizes, variance, and p-values. It focuses solely on biochemical surrogate markers without reporting clinical outcomes such as mortality, duration of mechanical ventilation, or bronchopulmonary dysplasia.

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