Growth and development until 18 months of children exposed to tocolytics indomethacin or nylidrin.

Indomethacin, a prostaglandin synthesis inhibitor, is a more efficient tocolytic than the beta-sympathomimetic nylidrin, but causes more frequent unwanted effects in the neonatal period. In order to elucidate the effects on neurodevelopment, infants randomly exposed in utero to either compound were followed up to 18 months. A total of 93 children (40 exposed to nylidrin and 53 exposed to indomethacin) were examined at the age of 12 months. A detailed neurological examination was carried out in 44 of these infants at the age of 18 months. At the age of 12 months the children in the indomethacin group showed poor outcome (death or severe BPD and/or CP and/or severe ROP) in 23% and the children in the nylidrin group in 5% (p = 0.039, Fisher Exact Test). Concerning the children born during tocolysis the corresponding figures were 73% and 13% respectively (p = 0.002, Fisher Exact Test). The growth of the children did not differ significantly between the two treatment groups. Neurological assessment at the age of 18 months revealed more subnormally scoring children in the indomethacin group, but the differences were not significant. It was concluded that the higher incidence of poor outcome and a lest favourable neurological development in the indomethacin group do not support indomethacin's position as the drug of choice for tocolysis.

RCT Entities:   Population Interventions Outcomes