Nebulized pentoxifylline for prevention of bronchopulmonary dysplasia in very low birth weight infants: a pilot clinical study.

Objective: To evaluate the effectiveness of nebulized pentoxifylline (PTXF) compared to intravenous dexamethasone (DX) or placebo (nebulized distilled water) for the prevention of bronchopulmonary dysplasia (BPD).

Methods: One hundred and fifty very low birth weight infants were randomly assigned to three groups. Entry criteria were the need for oxygen administration on the fourth day of life, irrespective of whether ventilatory support was required. PTXF was administered with a nebulizer every 6 hours on three consecutive days (a single course) in a dose of 20 mg/kg when infants were breathing spontaneously or 10 mg/kg when they needed ventilatory support. DX was given every 12 hours on three consecutive days in a dose of 0.25 mg/kg. Nebulized distilled water was administered with the schedule of inhalation as in the PTXF group. When the need for ventilatory support or oxygen dependency persisted, the course of both drugs and placebo administration was repeated every seven days until the diagnosis of BPD was established.

Results: Both PTXF and DX reduced the incidence of disease when compared with placebo. The respective data obtained for the PTXF-group versus the placebo group were as follows: difference in risk, 27%; OR: 0.32; CI: 0.11-0.94; p = 0.039; whereas the results for the DX-group versus the placebo group were: difference in risk, - 23%; OR: 0.39; CI: 0.14-1.14; p = 0.07.

Conclusion: Our data show that nebulized PTXF reduces the risk of BPD and may be a potential alternative to steroids in the prevention of this disease.