Pentoxifylline for the prevention of infants BPD New Cochrane review

Schulzke SM, Kaempfen S, Patole SK24 Novem­ber 2014

Babies who are born ear­ly (preterm) often suf­fer from long-last­ing breath­ing prob­lems known as bron­chopul­monary dys­pla­sia, which can lead to poor health in child­hood and adult­hood. Drugs that act on the body’s self-defense sys­tem may help to low­er the risk of long-last­ing breath­ing prob­lems. Pen­tox­i­fylline is one such drug. The main aim of this review was to find out whether pen­tox­i­fylline com­pared with place­bo (an inac­tive drug) or no drug offers impor­tant advan­tages to babies born ear­ly. Only one study of mod­er­ate size and qual­i­ty was iden­ti­fied in this review. This study did not show strong evi­dence that pen­tox­i­fylline offers impor­tant advan­tages to babies born ear­ly. We have there­fore been unable to deter­mine the effects of pen­tox­i­fylline in pre­vent­ing long-last­ing breath­ing prob­lems in babies born ear­ly. Future high-qual­i­ty stud­ies are need­ed to answer this ques­tion.

Back­ground: 

Bron­chopul­monary dys­pla­sia (BPD) is a com­mon com­pli­ca­tion in preterm infants. BPD is asso­ci­at­ed with poor long-term res­pi­ra­to­ry and neu­rode­vel­op­men­tal out­come and increased mor­tal­i­ty. The pro­phy­lac­tic use of agents that mod­u­late inflam­ma­tion such as pen­tox­i­fylline, a syn­thet­ic methylx­an­thine and phos­pho­di­esterase inhibitor, may reduce the inci­dence of BPD.

Objec­tives: 

The pri­ma­ry objec­tive of this review was to deter­mine the effect of pen­tox­i­fylline on the inci­dence of BPD, death pri­or to 36 weeks post­men­stru­al age (PMA), and BPD or death pri­or to 36 weeks PMA in preterm neonates.

Main results: 

We iden­ti­fied one ran­domised clin­i­cal tri­al eli­gi­ble for inclu­sion in this review. This study com­pared the use of neb­u­lised pen­tox­i­fylline ver­sus place­bo for pre­ven­tion of BPD in 100 preterm infants and was at high risk of bias due to lack of blind­ing of inter­ven­tion and out­come asses­sors, and incom­plete out­come data. There was no sta­tis­ti­cal­ly sig­nif­i­cant effect of neb­u­lised pen­tox­i­fylline ver­sus place­bo on indi­vid­ual out­comes of BPD at 36 weeks PMA or on death pri­or to 36 weeks PMA. There was no sig­nif­i­cant effect of neb­u­lised pen­tox­i­fylline on intra­ven­tric­u­lar haem­or­rhage, periven­tric­u­lar leuko­ma­la­cia, sep­sis, or patent duc­tus arte­rio­sus (PDA) requir­ing lig­a­tion. The study did not report any of the oth­er sec­ondary out­comes con­sid­ered for this review. Report­ing of adverse events was very lim­it­ed and did not allow for reli­able judge­ment on the inci­dence of such events. No long-term out­comes were report­ed.

Authors’ con­clu­sions: 

There is insuf­fi­cient evi­dence to deter­mine the safe­ty and effi­ca­cy of pen­tox­i­fylline for pre­ven­tion of BPD in preterm neonates. We encour­age researchers to con­duct clin­i­cal tri­als to con­firm or refute the role of pen­tox­i­fylline for pre­ven­tion of BPD in preterm neonates. These tri­als should report on clin­i­cal­ly impor­tant out­comes and, ide­al­ly, on long-term neu­rode­vel­op­men­tal out­come.