Nebulized Pentoxifylline for Reducing the Duration of Oxygen Supplementation in Extremely Preterm Neonates
Sven M. Schulzke, Mangesh Deshmukh, Elizabeth A. Nathan, Dorota A. Doherty, Sanjay K. Patole
DOI:
http://dx.doi.org/10.1016/j.jpeds.2015.01.040 Abstract
Objective
To evaluate the efficacy and safety of nebulized pentoxifylline for reducing the duration of oxygen supplementation in extremely preterm neonates at high risk of bronchopulmonary dysplasia (BPD).
Study design
Single-center, randomized, double-blind, placebo-controlled trial was conducted. Infants of 230to 276weeks' gestational age requiring mechanical ventilation or ≥30% supplemental oxygen on continuous positive airway pressure at 72-168hours were randomized to receive 20mg/kg (1mL/kg) nebulized pentoxifylline or an equal volume of normal saline placebo every 6hours for 10 consecutive days via a vibrating mesh nebulizer. The primary outcome was the duration of oxygen supplementation at 40weeks' postmenstrual age. We used Cox proportional hazards regression modeling to yze outcomes.
Results
All infants had adequate data for ysis of the primary outcome. Intention-to-treat ysis revealed no differences in duration of oxygen supplementation at 40weeks' postmenstrual age between pentoxifylline (n = 41) and placebo (n = 40) groups (median 2262 vs 2160hours, adjusted hazard ratio: 1.14, 95% CI 0.72-1.80,P= .63). There was no difference in mortality and further secondary outcomes. No adverse effects were noted.
Conclusions
Nebulized pentoxifylline is safe but did not reduce the duration of oxygen supplementation in extremely preterm infants at high risk of BPD. Dose-ranging studies and large, well-designed clinical trials are required to determine whether the use of nebulized or systemic pentoxifylline as a prophylactic therapy offers all but relevant benefits for prevention of BPD.
