Design-Stage Trial of Gentamicin in the Uniject Device

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• Afraid the family of the sick newborn would be unhappy or dissatisfied if the health of thenewborn did not improve.• Afraid that the injection would be given in the wrong location or hit the bone.• Afraid that giving seven injections would harm the newborn.• Afraid that the full treatment could not be given to the newborn because the FCHV or thenewborn was not at home.During FGDs, participants in all groups were asked about the advantages and disadvantages of thefeatures of gentamicin in Uniject. Responses are included in Table 14.Table 14. Advantages and disadvantages of gentamicin in Uniject as identified byFCHVs.AdvantageNumber of groups thatmentioned featureEasy to differentiate bycolor/select the doseNo need to mix drug ordraw syringe(5)Easy to carry (3)Safe for person injecting (3)Easy to dispose (2)Does not break (2)Easy to use/inject (2)Can be kept in bag (1)Easy to store (1)DisadvantageNumber of groups thatmentioned feature(5) Difficult to squeeze bulb (2)Not able to leave houseduring injection period(1)4.5 SupervisionSupervision was an important component of this study. All supervisors were requested to providesupervision and support to their FCHVs while giving gentamicin in Uniject. In particular, the immediatesupervisor certified the competency of the FCHV after observing the completion of treatment oftheir first case.Supervisors provided regular supervision for the first case as well as the second dose of all subsequentcases. All 33 FCHVs who treated 67 PSBI cases with gentamicin in Uniject received guidancefrom their supervisors. On average, one supervisor had to supervise six PSBI cases over thecourse of the study. The range of cases that supervisors had to monitor was from 1 to 15 over thestudy period.While analyzing the difficulties faced, one-half (n=6) of supervisors (n=12) reported facing difficultiesin supervising FCHVs giving gentamicin in Uniject, and the remaining six did not have any problems.Supervisors reported the most common problems as being managing time, transportation cost,communication cost (using their personal cell phones), and lack of simple commodities such assoap for handwashing in caretakers’ homes.Final Report(34) Gentamicin in Uniject: A Feasibility Study
During their supervision, none of thesupervisors found FCHVs making anymistakes while assessing the babies.However, 6% of FCHVs were foundmaking mistakes while giving gentamicinin Uniject. Among them, one had aproblem squeezing the bulb to inject themedicine and another faced a problemholding the baby in the right position, aswell as holding the Uniject device. Thisresulted in slight bleeding from theinjection site. When asked about the needFigure 25. Field coordinator conductingcompetency certification during training.for external supervision of FCHVs tocontinue providing services with gentamicin in Uniject, four supervisors reported that additionalsupervision was not necessary. For the remaining five supervisors, improvement of skills, filling thegap of humanresources, sharing experiences, and regular logistic supply were some of the reasons for the needfor external supervision.For the most part, supervisors observed the FCHVs giving the gentamicin in Uniject injections atleast once during the 7-day course of treatment. The FCHVs in the FGDs noted that supervisorswere amenable to conducting observation visits in the home of the newborn even on holidays suchas Saturday or when they did not have a vehicle. Some FGD participants reported that supervisorswere not able to make the visits due to political strikes, equipment failure such as flat tires on theirmotorcycles, or very long distance to the home. Other participants noted that if the supervisor wasnot able to reach the FCHV on time to observe the injection, he observed her treatment recordsand asked questions about the treatment process.Although FCHVs unanimously agreed that using gentamicin in Uniject was easy, they also appreciatedthe support given to them by their supervisors—especially during their initial use of the device.Many FGD participants stated that the presence of the supervisor helped them overcome theirinitial fear and anxiety related to the use of gentamicin in Uniject, as noted by the following participant:“Initially, I was worried that something might go wrong. But the presenceof the supervisor helped me overcome that worry.” Dainiya VDCFGD participants reported that supervisors often came for all seven doses even though the studyprotocol required them to visit only once during treatment, within 48 hours of the first dose. Thislevel of supervision reduced in some VDCs over time:“In the first case that I treated, the supervisor came for seven days. In thesecond case, he came for two times. If the supervisor is in front, then he/she will correct your mistake immediately. But without the presence ofsupervisors, we can also give injections.” Sorabhag VDCGentamicin in Uniject: A Feasibility Study(35)Final Report
Page 1: Design-Stage Trial of Gentamicinin
Page 4 and 5: Study investigatorsDr. Y. V. Pradha
Page 7 and 8: Table of contentsAcknowledgmentsiii
Page 9 and 10: Figure 13. District Public Health A
Page 11 and 12: Executive SummaryThis design-stage
Page 13 and 14: Data were collected during the inte
Page 15 and 16: 1. Introduction and rationaleEvery
Page 17 and 18: 2. Background2.1 Community-based ma
Page 19 and 20: ners for improving newborn health a
Page 21 and 22: When the FCHV assesses a youngFigur
Page 23 and 24: These studies occurred with the col
Page 25 and 26: with suspected sepsis in the neonat
Page 27 and 28: 3. Study methods3.1 Description of
Page 29 and 30: The following research objectives w
Page 31 and 32: health facility, where they receive
Page 33 and 34: community level. The trainings were
Page 35 and 36: infections, and ENC messages. The t
Page 37 and 38: Table 4. Data collection instrument
Page 39 and 40: 4. ResultsData were collected durin
Page 41 and 42: Figure 19. Knowledge on device perf
Page 43 and 44: Figure 22. Knowledge of the Uniject
Page 45 and 46: VHWs/MCHWs. Among them were 3 very
Page 47: color-coded weight category, and th
Page 51 and 52: 56% of them were able to breastfeed
Page 53 and 54: for sick young infants by FCHVs at
Page 55 and 56: 5. DiscussionThe gentamicin in Unij
Page 57 and 58: phones to contact their supervisors
Page 59 and 60: 6. Limitations of the studyAll stud
Page 61 and 62: 14. Bahamondes L, Marchi NM, de Lou
Page 63 and 64: 2007Possible Severe Bacterial Infec
Page 65 and 66: Steps for Injection:1 2Wash your ha
Page 67 and 68: Appendix CGovernment of NepalMinist
Page 69 and 70: Government of NepalMinistry of Heal
Page 71 and 72: Consent from guardian Yes NoWeight
Page 73 and 74: Appendix EPreparing for trainingDPH

Design-Stage Trial of Gentamicin in the Uniject Device

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