Design-Stage Trial of Gentamicin in the Uniject Device

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• Semi-annual distribution of high-dose vitamin A capsules to children 6–59 months of age.• Distribution of deworming tablets to children 1–5 years old.• Provision of oral rehydration salts (and zinc in some districts) for diarrhea cases.• Iron-folate tablet distribution for pregnant women.• Provision of postpartum vitamin A.• Advice on antenatal care, breastfeeding, and infant feeding.• Immunization.• General first aid.The community trusts these health workers for advice on many health-related issues. The VHWsand MCHWs are the immediate supervisors of the FCHVs and support them in their work.Nepal’s successful community-based programs with dedicated volunteers and health facility staff,plus general systems strengthening within the MOHP, have contributed to a continued decline inthe total fertility rate and under-five mortality indicators over the past 15 years, despite the politicalinstability in the country (Figure 1). For the 5-year period preceding the 2006 Demographic andHealth Survey, the under-five mortality rate (U5MR) was 61 per 1000 live births, the infant mortalityrate (IMR) was 48 per 1000 live births, and the neonatal mortality rate (NMR) was 33 per 1000live births. Therefore, the neonatal mortality rate represented more than one-half of all deaths ofchildren younger than 5 years in the country.Figure 1. Trends in child mortality in Nepal, 1996–2006.MDG: Millennium Development Goal.Source: 2006 Demographic and Health Survey.These findings—along with earlier work for the preparation of a situational analysis of newbornhealth in 2002, the development of the National Neonatal Health Strategy in 2004, and other MOHPinitiatives—helped consolidate the growing commitment within the government and among part-Final Report(4) Gentamicin in Uniject: A Feasibility Study
ners for improving newborn health and survival. In order to achieve Millennium Development Goal4 (Reduce Child Mortality), it was apparent that the main killers of neonates (infection, birth asphyxia,and the complications of low birth weight and prematurity) must be addressed urgently.In 2004, the MOHP introduced a community-based pilot program in Morang district, a large districtin the eastern terai (flatland) of Nepal, to address the high mortality attributed to neonatal infectionsand sepsis. This initiative was implemented with technical support and oversight from the JohnSnow, Inc. (known as JSI) Research and Training Institute and funding from the Saving NewbornLives program of Save the Children with support from the Bill & Melinda Gates Foundation. TheUnited States Agency for International Development (USAID) provided additional financial andtechnical support and facilitated later expansion of the program to the whole district through theNepal Family Health Program (NFHP). It was implemented entirely through the existing publichealth system of the MOHP, under the direction of the District Public Health Office (DPHO).This pilot program was called the Morang Innovative Neonatal Intervention (MINI). The publichealth services of Morang district are coordinated through the DPHO located in the district headquarters,Biratnagar. According to the national health policy of Nepal, each of the 65 VDCs ofMorang have at least one health institution, and their distribution is as follows: 7 primary health carecenters, 10 health posts, and 49 SHPs.The FCHVs in Morang had also been previously trained on the assessment and management ofchildren with pneumonia. Since 1995, FCHVs have treated children 2 months to 5 years of agewith oral pediatric cotrimoxazole (cotrimoxazole-p) tablets for pneumonia. They are familiar withthe use of a timer to count respiratory rate and assessment of young infants for danger signs. Theyhave been trained to refer sick young infants younger than 2 months and those with “severe pneumonia”to the nearest health facility for further assessment and treatment.The MINI program trained and supported the FCHVs to visit homes in their villages within 24hours of birth to weigh the newborn, prepare a simple record of the birth, assess the neonate forany danger signs of infection, and alert the mother and caretakers to call the FCHV immediatelyfor reassessment if any danger signs occur. FCHVs also teach families about essential newborncare (ENC) and additional care needed for low weight babies. Through the MINI program, FCHVsin Morang have also been trained to identify and initiate management of both local bacterial infectionsand possible severe bacterial infections (PSBIs) in young infants (0–59 days of age).While FCHVs are not asked to attend deliveries as part of the MINI intervention, they are awareof the pregnant women in their communities, as they maintain a pregnancy surveillance registerand provide iron-folate tablets to pregnant women. During these antenatal contacts, FCHVs providecounseling on birth preparedness and recommend that women seek antenatal care from thehealth facility staff (including tetanus toxoid injections). In addition, through MINI, FCHVs talkabout ENC practices and describe the danger signs of neonatal infections, and leave colorful informationflyers with families that describe these danger signs. FCHVs also ask families to informthem immediately after the birth, so they can return to the home and conduct an initial assessmentof the newborn.Gentamicin in Uniject: A Feasibility Study(5)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: 2. Background2.1 Community-based ma
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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