Design-Stage Trial of Gentamicin in the Uniject Device

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Acronyms and abbreviationsAHWARIBIOLCHWCMCCotrimoxazole-pDPHODSHENCFCHVFGDGMPGoNHFHIVMCHWMINIMOHPNFHPPATHPIPSBIPTSGCSHPUSAIDVDCVHWauxiliary health workeracute respiratory infectionInstituto Biologico Argentinocommunity health workerChristian Medical College and HospitalPediatric cotrimoxazoleDistrict Public Health OfficeDhaka Shishu Hospitalessential newborn carefemale community health volunteerfocus group discussionGood Manufacturing PracticeGovernment of NepalHealth facilityHuman immunodeficiency virusMaternal and child health workerMorang Innovative Neonatal InterventionMinistry of Health and PopulationNepal Family Health ProgramProgram for Appropriate Technology in Healthpost-implementationpossible severe bacterial infectionpost-trainingserum gentamicin concentrationsub-health postUnited States Agency for International Developmentvillage development committeevillage health worker(ix)
Executive SummaryThis design-stage trial was nonexperimental community research aimed toward assessing thefeasibility of gentamicin in the Uniject® device (hereafter referred to as gentamicin in Uniject)when used by female community health volunteers (FCHVs) in a peripheral care setting. Thestudy was conducted in five village development committees (VDCs) of Morang district, situatedin the eastern part of Nepal. The objectives of the study were to:• Explore the feasibility of gentamicin in Uniject in combination with oral pediatric cotrimoxazole(cotrimoxazole-p) for treatment of neonatal infection when administered at home by FCHVs.• Determine the level of motivation of FCHVs for the added responsibility.• Explore the acceptability of administration of gentamicin in Uniject by FCHVs as a treatmentfor neonatal sepsis to caretakers and community members.The study was conducted under the leadership of the Child Health Division of the Ministry ofHealth and Population (MOHP) Nepal. It was a partnership between the Child Health Division,Nepal Family Health Program II/United States Agency for International Development (USAID),PATH, and the Morang Innovative Neonatal Intervention (MINI) program. Financial support forthe program was provided by the USAID Nepal Mission, and the gentamicin in Uniject was providedby PATH. The study was approved by the MOHP Nepal, the Nepal Health Research Council, andPATH’s Research Ethics Committee. The intervention activities and tools were designed based onongoing MINI activities in Morang district. Most of the training materials used in the MINI programwere adapted by technical experts from all the organizations involved in the study. A separatetraining module, classification card, color-coded weighing scale, color-coded thermometer, pictorialtreatment register, call form, birth record form, safe-disposal box, and standard data collectionforms were used in this study.A local orientation about the study was conducted for community leaders and members in eachVDC before the intervention began. A 2-day training session was provided to health workers aboutthe use of gentamicin in Uniject, and the FCHV training curriculum was covered in 4 days. Thetrainings utilized participatory methods and opportunities for all participants to perform hands-onassessment and treatment. Fresh, whole eggplants were used to practice injection skills. A posttrainingquestionnaire was administered to all trainees to evaluate the effectiveness of the trainingcurriculum. All health workers and FCHVs took a competency certification test. Only those FCHVswho passed this certification were provided with gentamicin in Uniject to take home. All the FCHVswere again certified competent by their immediate supervisors after being observed giving all thedoses of gentamicin in Uniject to the first sick newborn after the training. After completion of thestudy, the competency certification was again performed with all the FCHVs to assess the retentionof skills in administering gentamicin in Uniject. The community health workers and caretakerswere periodically interviewed using standard forms. At the end of the study, focus group discussions(FGDs) with FCHVs in each VDC, in-depth interviews with the supervisors of FCHVs in eachcommunity, and key informant interviews with two community leaders in each VDC were conducted.Consent was obtained for each type of activity.(xi)
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: Figure 13. District Public Health A
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 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
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Design-Stage Trial of Gentamicin in the Uniject Device

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