Related Experiment Videos
Growth and development until 18 months of children exposed to tocolytics indomethacin or nylidrin
T Salokorpi1, M Eronen, L von Wendt
1Department of Paediatric Neurology, University of Helsinki, Finland.
Insights
Indomethacin, a prostaglandin synthesis inhibitor, showed higher rates of poor infant outcomes compared to nylidrin. This study suggests indomethacin is not the preferred tocolytic agent due to potential neurodevelopmental concerns.
Area of Science:
- Neonatal Medicine
- Pharmacology
- Neurodevelopmental Pediatrics
Background:
- Indomethacin is an effective tocolytic agent but associated with neonatal adverse effects.
- Nylidrin, a beta-sympathomimetic, is another tocolytic option.
- Comparative effects on infant neurodevelopment remain a concern.
Purpose of the Study:
- To compare the neurodevelopmental outcomes of infants exposed in utero to indomethacin versus nylidrin.
- To evaluate the safety and efficacy of these tocolytic agents up to 18 months of age.
Main Methods:
- Randomized follow-up study of infants exposed to indomethacin or nylidrin.
- Assessment at 12 months, with detailed neurological examination at 18 months.
- Evaluation of infant outcomes including mortality, bronchopulmonary dysplasia, cerebral palsy, and retinopathy.
Main Results:
- Indomethacin group had significantly higher rates of poor outcomes (23%) at 12 months compared to nylidrin (5%).
- Infants born during tocolysis showed markedly worse outcomes with indomethacin (73%) versus nylidrin (13%).
- Neurological assessments at 18 months indicated more subnormal scores in the indomethacin group, though not statistically significant.
Conclusions:
- The increased incidence of poor outcomes and less favorable neurodevelopmental profile do not support indomethacin as the drug of choice for tocolysis.
- Further research is warranted to fully understand long-term neurodevelopmental effects.
- Risk-benefit assessment favors alternative tocolytic strategies over indomethacin.
Abstract:
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.