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Design-Stage Trial of Gentamicin in the Uniject Device

Design-Stage Trial of Gentamicin in the Uniject Device

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observation <strong>of</strong> <strong>the</strong> FCHVs giv<strong>in</strong>g gentamic<strong>in</strong> <strong>in</strong> <strong>Uniject</strong>. Additionally, 14 call forms were given forregular gentamic<strong>in</strong> <strong>in</strong>jections for babies who weighed more than 3.5 kg, and 1 was referred afternot giv<strong>in</strong>g consent for treatment by <strong>the</strong> FCHV. All 33 first cases treated by FCHVs were supervisedeveryday for 7 days by <strong>the</strong>ir immediate supervisors, and <strong>the</strong> rema<strong>in</strong><strong>in</strong>g 34 cases were all supervisedfor <strong>the</strong> second dose. In all 67 cases, <strong>the</strong> FCHVs followed <strong>the</strong> correct disposal <strong>of</strong> used gentamic<strong>in</strong><strong>in</strong> <strong>Uniject</strong> devices by plac<strong>in</strong>g <strong>the</strong>m <strong>in</strong> <strong>the</strong> disposal box without recapp<strong>in</strong>g and by return<strong>in</strong>g <strong>the</strong> fulldisposal boxes to <strong>the</strong>ir respective supervisors.Tim<strong>in</strong>g <strong>of</strong> care for PBSIAround 82% <strong>of</strong> sick young <strong>in</strong>fants received <strong>the</strong>ir first dose <strong>of</strong> gentamic<strong>in</strong> <strong>in</strong> <strong>Uniject</strong> on <strong>the</strong> sameday as <strong>the</strong>ir first contact with <strong>the</strong> FCHV/VHW/MCHW/HF. The median time for <strong>the</strong> first visitprovided by <strong>the</strong> FCHVs for sick young <strong>in</strong>fants and <strong>the</strong> gap between <strong>the</strong> onset <strong>of</strong> illness and <strong>the</strong> firstdose <strong>of</strong> gentamic<strong>in</strong> <strong>in</strong> <strong>Uniject</strong> was 2 days (Table 13). This suggests that FCHVs were able to<strong>in</strong>itiate treatment for PSBI immediately upon <strong>the</strong>ir first visit. Accord<strong>in</strong>g to <strong>the</strong> caretaker <strong>in</strong>terviews,<strong>the</strong> median time lag between <strong>the</strong> first dose <strong>of</strong> cotrimoxazole-p and <strong>the</strong> first dose <strong>of</strong> gentamic<strong>in</strong> <strong>in</strong><strong>Uniject</strong> was 6.5 hours, due to <strong>the</strong> study requirement that supervisors be present at <strong>the</strong> time <strong>of</strong><strong>in</strong>jection <strong>of</strong> <strong>the</strong> first case.Table 13. Tim<strong>in</strong>g <strong>of</strong> care for PSBI by FCHVs.Median days <strong>of</strong> FCHV first visit for all young <strong>in</strong>fants*Median days <strong>of</strong> onset <strong>of</strong> illness to FCHV first visit for sick babies*Median days <strong>of</strong> illness to first dose <strong>of</strong> gentamic<strong>in</strong> <strong>in</strong> <strong>Uniject</strong>*Median time lag between cotrimoxazole-p and first dose <strong>of</strong>gentamic<strong>in</strong> <strong>in</strong> <strong>Uniject</strong>**2 days (m<strong>in</strong>imum 0, maximum 59 days)2 days (m<strong>in</strong>imum 0, maximum 9 days)2 days (m<strong>in</strong>imum 0, maximum 9 days)6.5 hours (m<strong>in</strong>imum 1, max 24 hours)4.4 Ease <strong>of</strong> use <strong>of</strong> <strong>the</strong> gentamic<strong>in</strong> <strong>in</strong> <strong>Uniject</strong> device by FCHVsAmong <strong>the</strong> 45 FCHVs, 40 FCHVs (89%) reported that activation <strong>of</strong> <strong>the</strong> gentamic<strong>in</strong> <strong>in</strong> <strong>Uniject</strong>device was easy and <strong>the</strong> rema<strong>in</strong><strong>in</strong>g 5 FCHVs (11%) found it acceptable. None <strong>of</strong> <strong>the</strong> FCHVsreported activation <strong>of</strong> gentamic<strong>in</strong> <strong>in</strong> <strong>Uniject</strong> was difficult. Similarly, 35 FCHVs (78%) found it easyto give gentamic<strong>in</strong> <strong>in</strong> <strong>Uniject</strong>, 9 (20%) felt it was acceptable, and 1 FCHV reported difficultieswhile giv<strong>in</strong>g gentamic<strong>in</strong> <strong>in</strong> <strong>Uniject</strong>. Eighty percent (n=36) <strong>of</strong> <strong>the</strong> FCHVs liked <strong>the</strong> gentamic<strong>in</strong> <strong>in</strong><strong>Uniject</strong> device very much, while 16% (n=7) liked it but had some problems, and 4% (n=2) did notlike <strong>the</strong> device.Among <strong>the</strong> 45 FCHVs, 43 reported that <strong>the</strong>y did not face any difficulties while giv<strong>in</strong>g gentamic<strong>in</strong> <strong>in</strong><strong>Uniject</strong> <strong>in</strong> <strong>the</strong> eggplant dur<strong>in</strong>g tra<strong>in</strong><strong>in</strong>g. However, among <strong>the</strong> 33 FCHVs who used gentamic<strong>in</strong> <strong>in</strong><strong>Uniject</strong> for treat<strong>in</strong>g young <strong>in</strong>fants, 2 FCHVs reported that <strong>the</strong>y had difficulty squeez<strong>in</strong>g <strong>the</strong> bulb to<strong>in</strong>ject <strong>the</strong> entire dose <strong>of</strong> medic<strong>in</strong>e; <strong>the</strong>y also faced problems while try<strong>in</strong>g to hold <strong>the</strong> baby <strong>in</strong> <strong>the</strong>correct position.FCHVs <strong>in</strong> all five FGDs expressed confidence <strong>in</strong> <strong>the</strong>ir selection <strong>of</strong> <strong>the</strong> correct dose <strong>of</strong> gentamic<strong>in</strong><strong>in</strong> <strong>Uniject</strong>. Select<strong>in</strong>g <strong>the</strong> correct dose required <strong>the</strong> FCHVs to weigh <strong>the</strong> baby, identify <strong>the</strong> newborn’sF<strong>in</strong>al Report(32) <strong>Gentamic<strong>in</strong></strong> <strong>in</strong> <strong>Uniject</strong>: A Feasibility Study

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