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Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial)
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  • Published on:
    PreROP Trial - Intention to treat analysis and Hypoglycemia monitoring
    • Kishore P Sanghvi, Neonatologist Jaslok Hospital And Research Centre, Mumbai
    • Other Contributors:
      • Nandkishore S Kabra, Neonatologist

    Dear Editor
    We genuinely appreciate the readers keen interest in our paper and critical comments.1 Here are our clarifications regarding their comments.
    1. The readers have perhaps misunderstood the concept of “intention to treat analysis” and “per protocol analysis”.2 Infants were analysed as they were randomized in their respective groups (intention to treat analysis). Per protocol analysis excludes the patients who deviate from the protocol. In our study, we needed to exclude the infants who were lost to follow-up and therefore their outcomes were not known. We did not exclude them because there was a protocol deviation or violation.
    2. Blood dextrose levels were monitored as per unit protocol and once stable on full enteral feeds they were done once a week along with weekly routine blood evaluations up to discharge. No additional testing for blood sugars was done for the study.
    3. We believe that propranolol at lower doses of 0.5mg/kg/dose 12 hourly is unlikely to affect the normal vascularization in other organs. This drug has been previously used in newborns including preterm newborns for different indications. Till date there have been no reports of deranged neuro-developmental outcome attributed to propranolol. However, we agree with the readers thoughts that long term neuro-developmental outcome would have been useful but this was beyond the scope of this study.
    4. In our study, for babies born at 31-32 weeks post menstrual age the...

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    Conflict of Interest:
    None declared.
  • Published on:
    Letter to editor
    • Prathik Bandya, Assistant professor of Neonatology Indira Gandhi Institute of Child Health, Bangalore
    • Other Contributors:
      • Tapas Bandyopadhyay, Assistant Professor of Neonatology

    Dear Sir/Madam,
    We read with great interest the article by Sanghvi et al1 titled “Sanghvi KP, Kabra NS, Padhi P, Singh U, Dash SK, Avasthi BS. Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial). Arch Dis Child Fetal Neonatal Ed. 2017 Jan 13. pii: fetalneonatal-2016-311548. doi: 10.1136/archdischild-2016-311548. [Epub ahead of print]” published in your journal which concluded that prophylactic propranolol in the prescribed dose of 1 mg/kg/day showed a decreasing trend in all outcomes of ROP though statistically not significant. We appreciate that it was a double blinded study which tried to see the effect of propranolol prophylaxis on ROP prevention in lower doses without any serious adverse events.

    This trial was need based and addressed a very important and clinically relevant issue. However, we would like to address a few important concerns which came to our notice while reading through the article.

    The authors state that the analysis was planned according to intention to treat(ITT) analysis, but if we see the final analysis in flow diagram, the babies which were lost to follow up are not included in the analysis. Thus, it is not a ITT but a per protocol analysis.2

    The babies received study drug till 37 weeks or till complete vasularization of retina. Were blood dextrose levels monitored till this time? If the response is yes, then this would expose these tiny neonates to unnecessary daily pricks and pa...

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    Conflict of Interest:
    None declared.