N-acetylcysteine does not prevent bronchopulmonary dysplasia in immature infants: a randomized controlled trial☆

Abstract 

Objective

To evaluate whether N-acetylcysteine (NAC) infusion during the first week of life reduces the risk of death or bronchopulmonary dysplasia (BPD) in infants with extremely low birth weight.

Study design

In a Nordic multicenter, double-blind trial, infants (n=391) weighing 500 to 999 g and on ventilator or nasal continuous positive airway pressure were randomized before the age of 36 hours to receive NAC 16 to 32 mg/kg/d (n=194) or placebo (n=197) intravenously for 6 days. Primary end points were death or BPD, defined as supplementary oxygen requirement at 36 weeks' gestational age.

Results

There was no difference in the combined incidence of the primary end points death or BPD, 51% vs. 49%, between the NAC group and control group. Also similar was the incidence of BPD in survivors at 36 weeks' gestational age, 40% vs. 40%, and the mean oxygen requirement at the age of 28 days, 31.2% vs. 30.7%, respectively. The severity of BPD was similar in both groups.

Conclusions

A 6-day course of intravenous N-acetylcysteine at the dosage used does not prevent BPD or death in infants with extremely low birth weight.

Abbreviations:  BPD, Bronchopulmonary dysplasia, IVH, Intraventricular hemorrhage, NAC, N-acetylcysteine, NEC, Necrotizing enterocolitis, PVL, Periventricular leukomalacia, ROP, Retinopathy of prematurity