Design-Stage Trial of Gentamicin in the Uniject Device

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Morang was the most suitable site for this design-stage feasibility study due to the existing MINIprogram and research infrastructure. The FCHVs were already familiar with the techniques fordiagnosis and management of neonatal sepsis, so only the use of the device needed to be added asa new skill, along with correct disposal and recording of services. Further, the MINI office andinfrastructure were already in place in the district headquarters, Biratnagar, to create a naturalbase for the study. The MINI database could be utilized to determine the VDCs with large numbersof births, and the existing data management systems ensured good-quality data. In addition, closemonitoring and supervision of the study were possible due to the presence of the MINI fieldstaff.Five VDCs in Morang district with high birth rates and political stability were selected for inclusionin the study (Table 2). Selection of VDCs was purposive. Those with a high volume of PSBIepisodes—as seen in the MINI database—were selected in order to maximize the likelihood ofhaving adequate cases and also to vary the geographic settings. The five VDCs selected wereDainiya, Sorabhag, Govindapur, Madhumalla, and Hatimuda (Figure 9).Table 2. VDC characteristics.Estimated totalpopulationEstimated populationyounger than 1 yearEstimated populationyounger than 5 yearsEstimated MWRApopulationEstimated expectedpregnanciesDainiya Sorabhag Govindapur Madhumalla Hatimuda14333 12168 17746 22799 9398331 281 410 527 2171744 1481 2159 2774 11432747 2332 3401 4369 1801549 466 680 874 360MWRA: married women of reproductive age.Source: Morang DPHO, 2009.3.2 Research questions and objectivesThe primary research question of the study: Is gentamicin in Uniject, in combination with oralcotrimoxazole and an appropriate scale, a feasible option for the treatment of neonatal sepsis whenadministered at home by FCHVs?Secondary research questions:• Will the FCHVs be motivated and able to continue to use this treatment modality in a programsetting, as it will require a larger time commitment than their current responsibilities?• Will the administration of gentamicin in Uniject by FCHVs as a treatment for neonatal sepsis beacceptable to community members?Final Report(14) Gentamicin in Uniject: A Feasibility Study
The following research objectives were established:1. Evaluate health worker comprehension of training materials on the use of the gentamicin inUniject device in combination with an appropriate scale, including choosing the correct doseand dosing schedule and adhering to the correct dosing schedule.2. Assess performance of gentamicin in Uniject characteristics, such as ease of use, dose accuracy,safety, and ease of disposal among health workers.3. Assess acceptability of using gentamicin in Uniject by health workers and the community.3.3 Study designThis was a post-test study only, a nonexperimental research design aimed toward assessing thefeasibility of the gentamicin in Uniject device when used by FCHVs in a peripheral care setting.Newborn infants up to 59 days of age who weighed less than 3500 grams and who were suspectedof having PSBI as per the standardized diagnostic protocol/algorithm were treated with gentamicinand oral cotrimoxazole-p as per the MINI program standard of practice. In this study, the gentamicinwas delivered via the Uniject device by FCHVs under supervision of a health worker (MCHW,VHW, or health facility in-charge).The primary unit of analysis was the FCHVs. Additional study participants included newborn infantswho were treated with gentamicin in Uniject, caretakers of infants who were treated with gentamicinin Uniject, and community leaders.Eligibility inclusion criteria for the four groups of participants (health workers, sick young infants,caretakers of sick young infants, and local community leaders) were as follows:1. Health providers, designated FCHVs, VHWs, MCHWs, or health facility workers who weretrained on the use of gentamicin in Uniject and who were working in the MINI program areaduring the study period. The term “community health worker” (CHW) was used collectively torefer to FCHVs, VHWs, or MCHWs.2. Newborn infants up to 59 days who weighed less than 3500 grams and were suspected ofhaving PSBI per standardized diagnostic protocol.3. Adult (age 18 or older) responsible for the care of the enrolled young infant.4. Adult (age 18 or older) who was a member in a community group in the VDC where theintervention was taking place.Feasibility of the use of gentamicin in Uniject by FCHVs to treat sick young infants at home wasassessed by collecting data related to device performance, acceptability, indication accuracy, safety,and disposal. Both quantitative and qualitative data were collected using mixed methods.Gentamicin in Uniject: A Feasibility Study(15)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: 3. Study methods3.1 Description of
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 and 48: color-coded weight category, and th
Page 49 and 50: During their supervision, none of t
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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