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Paschal Mdoe,1 Venkatesh Mannar,2 Museveni Justine,1 Godfrey Guga,1 Rose Gadiye,1 Vincent Assey,3 Caroline Kimathi,1 Fatma Abdallah,3 John Paschal,1 Estomih Mduma,1 Levente Diosady2 1Department of Obstetrics and Gynecology, Haydom Lutheran Hospital, Manyara, Tanzania; 2Department of Food Engineering, University of Toronto, Toronto, ON, Canada; 3Department of Food and Nutrition, Tanzania Food and Nutrition Center, Dar Es Salaam, TanzaniaCorrespondence: Paschal Mdoe, P.O. Box 9000, Manyara, Tanzania, Tel +255754429346, Email pfmdoe@gmail.comBackground: Micronutrients (iron, iodine, vitamin B12 and folate) deficiency is prevalent globally affecting more than two billion people majority being from low- and middle-income countries. Women of reproductive age are in an increased risk of iron deficiency. About 29.4% of women aged 15– 49 years worldwide are estimated to be affected by iron deficiency. Food fortification with micronutrients is important in addressing micronutrients deficiency.Aim: To evaluate if the quadruple fortified with iodine, iron, vitamin B12, and folic acid (QFS), will be more effective in improving the hemoglobin level of women aged 18 to 49 years compared to the double fortified with iodine and iron (DFS) and iodized salt in rural Tanzania.Methods: A double-blinded three-arm randomized controlled trial was conducted between July 2020 and December 2021 at the Haydom Lutheran Hospital catchment area. We randomized women aged 18– 49 years with haemoglobin between 8 and 12 g/dl who were neither pregnant nor lactating into three groups 55 Iodized salts (IS), 57 Double fortified salt (DFS), and 57 quadruple fortified salt (QFS). The participants used study salt for 10 months.Results: Over the ten months of use of study salts, the overall mean haemoglobin level of women was significantly higher in QFS by 0.43g/dl compared to IS. The ferritin levels were significantly higher in QFS and DFS by 9.60ng/mL and 9.09ng/mL, respectively, compared to IS. Vitamin B12 was insignificantly higher in QFS by 52.19pg/mL compared to DFS, and folate concentration were insignificantly higher in QFS by 7.57nmoL/L and 4.51nmoL/L compared to DFS and IS groups, respectively.Conclusion: Salt fortification with iron, iodine, folate, and Vitamin B12 is feasible and has the potential to increase the serum ferritin, Vitamin B12 and folate levels with subsequent improvement of haemoglobin levels of individuals with relatively low haemoglobin.ClinicalTrial.org Number: NCT04404751.Keywords: iron-deficiency anemia, iodine, iron, vitamin B12, folate

Abstract Background The stillbirth rate in Tanzania remains high. Greater engagement with antenatal care may help to reduce stillbirths. We investigated which characteristics of antenatal care clinics are preferred by pregnant women in Tanzania. Methods We conducted an unlabelled discrete choice experiment (DCE) with think-aloud interviews. Participants were pregnant women, regardless of parity/gestation, from the Mwanza and Manyara regions of Tanzania. We asked participants to choose which of two hypothetical antenatal clinics they would rather attend. Clinics were described in terms of transport mode, cleanliness, comfort, visit content, and staff attitude. Each participant made 12 choices during the experiment, and a purposively selected sub-set simultaneously verbalised the rationale for their choices. We analysed DCE responses using a multinomial logit model adjusted for study region, and think-aloud data using the Framework approach. Results We recruited 251 participants split evenly between the 2 geographical regions. Staff attitude was the most important attribute in clinic choice and dominated the think-aloud narratives. Other significant attributes were mode of transport (walking was preferred) and content of clinic visit (preference was stronger with each additional element of care provided). Cleanliness of the clinic was not a significant attribute overall and the think-aloud exercise identified a willingness to trade-off cleanliness and comfort for respectful care. Conclusion Women would prefer to attend a clinic with kind staff which they can access easily. This study suggests that exploration of barriers to providing respectful care, and enabling staff to deliver it, are important areas for future investment. The DCE shows us what average preferences are; antenatal care that is aligned with identified preferences should increase uptake and engagement versus care which does not acknowledge them.

This study intended to evaluate the larvicidal activity of Feronia limonia leaf essential oil against the wild population of Anopheles arabiensis Patton larvae in laboratory and semi-field environments. Larvae mortality was observed after 12, 24, 48, and 72 hours of exposure. In laboratory condition, the essential oil showed good larvicidal activity against An. arabiensis (LC50 = 85.61 and LC95 = 138.03 ppm (after 12 hours); LC50 = 65.53 and LC95 = 117.95 ppm (after 24 hours); LC50 = 32.18 and LC95 = 84.59 ppm (after 48 hours); LC50 = 8.03 and LC95 = 60.45 ppm (after 72 hours), while in semi-field experiments, larvicidal activity was (LC50 = 91.89 and LC95 = 134.93 ppm (after 12 hours); LC50 = 83.34 and LC95 = 109.81 ppm (after 24 hours); LC50 = 66.78 and LC95 = 109.81 (after 28 hours); LC50 = 47.64 and 90.67 ppm (after 72 hours). These results give an insight on the future use of F. limonia essential oils for mosquitoes control.

BackgroundClear evidence exists that perinatal audit and feedback can lead to important improvements in practice. The death audit can lead to the identification of existing potential delays which are the decision to seek medical care, reaching an appropriate facility, and receiving timely adequate care at the facility. Such an audit potentially initiates a positive discussion, which may foster the implementation of changes that aims at saving more lives.ObjectiveTo review the perinatal deaths case notes and identify potential gaps in care provision and health-seeking behavior to foster best practice.MethodsThe stillbirths and neonatal death case notes that occurred between January 2019 and May 2020 at the hospital were reviewed using an adapted WHO checklist. The completed review case notes were entered into an electronic system and a quality control check-up was done. Data were analysed descriptively, and findings were presented in tables.ResultsThere were 4,898 births, and 1,175 neonatal admissions, out of these there were 135 recorded stillbirths (2.8%) and 201(4.1% of the total hospital births) early neonatal deaths. Out of the 1,175 neonates, 635 (54%) were born within the hospital and 540 (46%) were admitted from other facilities and home deliveries. In total 86 stillbirths and 140 early neonatal deaths case notes were retrieved and audited. Out of 86 stillbirths' case notes audited, 30 (34.9%) seemed to have died during labor, and of these 5 had audible fetal heart rate during admission. Apgar scores less than 7 at 5 minutes, prematurity, and meconium aspiration were the top three recorded causes of neonatal deaths. Inadequate/late antenatal care visits and home delivery were the maternal factors likely to have contributed to perinatal deaths. Inadequate labor monitoring (12%) and documentation (62%) were among the providers' factors likely to have contributed to perinatal deaths.ConclusionThis audit shows that there are high rates of preventable intrapartum stillbirths and early neonatal deaths. Both women and providers' factors were found to have contributed to the stillbirths and neonatal deaths. There is a need to encourage women to adequately attend antenatal care, utilize health facilities during birth, and improve maternity and neonatal care at the health facilities.

Newborn mortality is a global challenge with around 2.4 million neonatal deaths in 2019. One third of these occur within the first-and-only day of life with labour complications and birth asphyxia being the primary causes. Existing guidelines for newborn resuscitation are based on limited scientific evidence, and evidens based research is sought for. To increase our knowledge on resuscitation of newborns, it is crucial to first quantify what is currently being done in terms of therapeutic activities, such as ventilation and stimulation, and how they affect resuscitation outcomes. In the current study, the therapeutic activities during newborn resuscitation are quantified by estimating a timeline describing the start and stop of activities. The proposed approach is combining methods using both video and time series data recorded during resuscitation, where the predictions are based on the available sources. From video the activity recognition is done by a 3D CNN method. For the signal data feature extraction is performed on ECG and accelerometer signals and thereafter machine learning is done to perform stimulation detection. We show that best results are achieved with all signals and video available, for the activity "stimulation" we get an AUC of 0.86, sensitivity of 82.32%, specificity of 82.23%, and precision of 57.59%. If only signals or video is available we still get good results with AUC at 0.80, and 0.84 respectively. • Improved method for estimating when stimulation occurs during newborn resuscitation. • Combining signal- and video-based methods to improve performance. • An important step in understanding the newborn resuscitation process. [ABSTRACT FROM AUTHOR]

Abstract Breast cancer (BC) screening plays a major role in the prevention of BC through early detection and timely treatment. This study aims to determine the level of uptake of BC screening and associated factors. A community-based analytical cross-sectional study was conducted in Dodoma City, Tanzania from July to December 2020. The study included women aged 8 years and above without a known history of breast cancer. Multivariable logistic regression was used to determine the socio-demographic factors associated with BC screening. P value

Abstract Background People living with HIV (PLWH) are at a higher risk for developing diabetes and hypertension. Often services are separate for HIV and non-communicable diseases (NCDs), but how this impacts NCD care among PLWH is unknown. We aimed to understand the barriers and facilitators for prevention, early diagnosis and safe effective care for diabetes and hypertension among PLWH. Methods Semi-structured interviews (SSIs) were conducted with 10 healthcare professionals (HCPs) that care for PLWH, 10 HCPs that care for people with diabetes and hypertension and 16 PLWH with a comorbidity of diabetes and/or hypertension. Participants were recruited from two healthcare facilities in Dodoma, Tanzania and purposively sampled based on age and sex. Interviews were conducted in Swahili using pre-developed topic guides, audio recorded then translated verbatim into English. An inductive thematic analysis was conducted using The Framework Method. Results Three themes were found: organisational/healthcare system factors, individual factors and syndemic factors. Organisational/healthcare system factors comprised the only facilitators for prevention (education on lifestyle behaviours and counselling on adherence), but included the most barriers overall: fragmented services, no protocol for NCD screening and lack of access to diagnostic equipment were barriers for early diagnosis whereas the former plus lack of continuity of NCD care were barriers for safe effective care. Individual factors comprised four sub-themes, three of which were considered facilitators: HCPs’ knowledge of NCDs for early diagnosis, self-monitoring of NCDs for safe effective care and HCPs’ personal practice for both early diagnosis and safe effective care. HCPs’ knowledge was simultaneously a barrier for prevention and PLWH knowledge was a barrier for prevention and safe effective care. Syndemic factors comprised three sub-themes; all were barriers for prevention, early diagnosis and/or safe effective care: poverty and mental health of PLWH and HIV stigma. Conclusions Organisational/healthcare system, individual and syndemic factors were found to be interlinked with barriers and facilitators that contribute to the prevention, early diagnosis and safe effective care of diabetes and hypertension among PLWH in Tanzania; these findings can inform future initiatives for making small and large health system changes to improve the health of aging PLWH.

Abstract Aim To describe home‐based care and practices recommended for mothers after caesarean section (CS), existing in the literature. Design Systematic review. Methods This integrative literature review was conducted by using Google Scholar, PubMed and Hinari databases from its inception to June 2021. The search included research articles, protocols and guidelines that describe home care practice after CS and assessed for their quality. Synthesis of recommendations from the included literature was classified based on the type of study design, and the review was guided by methodology registered in Prospero (ID CRD42021276905). Results A total of 681 literatures were found, and 12 met the criteria. Recommended home care components were divided into four major categories; wound care practice (wound cleaning, drying and bandage change); nutrition (high‐protein diet, vitamin C, fibre and balanced diet); exercise (pelvic floor muscle, walking and breathing exercise) and hygiene (bathing and wearing clean clothes). There was limited literature addressing the components of perineal care and home environment. Varying recommendations were found regarding wound cleaning and dressing in the studies done in low‐ and high‐income countries.

Access to water is arguably the most crucial, yet underappreciated determinant of household income for pastoralist households in semiarid regions. This study examined the influence of water access for livestock on pastoralists’ household income in the semi-arid areas of Monduli District in Tanzania. The study employed a cross-sectional research design, in which primary data were collected using a semi-structured questionnaire from 367 randomly selected households. Quantitative data were analysed using the Statistical Package for Social Sciences (SPSS) version 20, whereby both descriptive statistics (frequencies and percentages) were determined. A multinomial logistic regression model was applied to examine the influence of water access to livestock on the household income of pastoralists. The findings indicate that household size (p=0.001) and levels of water access for livestock, namely medium (p=0.000) and high (p=0.006), influenced pastoralists’ household income, while maintaining a low level of water access for livestock as the reference category. The study concluded that the higher the level of water access for livestock, the higher is the household income. This study recommends that the Government of Tanzania and the Monduli District Council establish programs to boost pastoralist income by improving communal access to livestock water sources.

Timely diagnosis and management of diabetes and hypertension among people living with HIV (PLWH) is imperative; however, many barriers exist within the current model of care for these comorbidities. We aimed to understand how HIV, diabetes, and hypertension care should be delivered and the associated barriers and facilitators for the preferred delivery approach. We conducted semi-structured interviews with 16 PLWH with comorbidities of diabetes and/or hypertension (referred to hereafter as non-communicable diseases [NCDs]), 10 healthcare professionals (HCPs) that provide care for NCDs, and 10 HCPs that provide care for HIV. Participants were recruited from two healthcare facilities in Dodoma, Tanzania and interviewed in Swahili. Interviews were audio recorded, transcribed verbatim and translated into English. We used the differentiated service delivery building blocks as a framework to determine where, who, what and when care should be provided. We applied the Theoretical Domains Framework (TDF) to HCP transcripts to determine barriers and facilitators for the preferred integration approach. There was a consensus among participants that all care for NCDs should be provided for PLWH at HIV clinics (known as care and treatment centres [CTCs]) by either CTC doctors or NCD specialists. Participants preferred flexible follow-up care for NCDs and for it to be aligned with HIV follow-up appointments. The main barriers were mapped to the TDF domains of environmental context and resources, and social influences; the former included the lack of NCD medications, NCD diagnostic equipment, space, staff and guidelines whereas the latter included negative influences from peers and traditional healers. Several facilitators were mentioned regarding CTC HCPs' knowledge, skills, optimism and beliefs regarding their capabilities to care for PLWH with NCDs. The preferred integration approach should be tested, utilising the enabling factors described. The barriers described must be addressed with or without integration to achieve optimal care for PLWH with NCDs.

Background: Caesarean section (CS) deliveries are increasing and mothers are commonly discharged home early to continue with care. At home, mothers should be knowledgeable about how to take care of themselves and their babies. Studies have reported non-uniform antenatal health education and existing postnatal guidelines merely provide information about home care after CS. Exploration of the content of post-CS will provide input to standard and comprehensive post-CS home care guidelines to be used by nurse-midwives in educating post-CS mothers. Objective: To explore the content of home-based care education after caesarean section provided by Nurse Midwives in Maternity Units in Dodoma, Tanzania. Methodology: An exploratory qualitative study using in-depth interviews was conducted with 14 nurse midwives working in the maternity unit and 11 post-CS mothers attending their post-natal clinic at Makole Health Centre. Qualitative content analysis was used to generate themes that describe information about care of mothers at home after hospital discharge, provided by nurse midwives. Results: The study found that information about nutrition, maternal and newborn hygiene and caesarean wound care at home were the main components of health education provided to post-CS mothers. However, non-uniform and contradicting instructions were provided to post-CS mothers. Conclusion: This study reported non-uniform and contradicting health information provided by nurse-midwives on home care after CS. Even though nurse midwives recognize the importance of providing health education to post-CS mothers, a standard and practical home care guideline should be developed to guide health education and care of post-CS mothers at home to promote recovery.

Abstract Background Food fortification with micronutrients is an insufficiently used technology in developing countries. Salt is consumed in small, constant daily amounts by most people globally. Salt has been instrumental in delivering iodine to a wide population globally through fortification. There is a proven effective technology for fortifying iodinated salt with iron, folate, and Vitamin B12. Findings have shown that both Double (Iodine and iron) fortified salt (DFS) and quadruple (iron, iodine, folate, and vitamin B12) fortified salt (QFS) are effective in raising hemoglobin levels. Aim To assess the acceptability and gauge consumers’ willingness to use double-fortified and quadruple-fortified salt formulations. Methods We conducted an observational study involving 300 households at Haydom Lutheran Hospital catchment area in Northern rural Tanzania between October 2021 and April 2022. Each household was supplied with one type of salt (iodized salt (IS), DFS or QFS) for cooking common family dishes for one week. Thereafter, at least two adult members of the family who used the dishes cooked with study salt were interviewed using the adopted 5-point Hedonic scale. Results A total of 899 individuals were interviewed after using study salt for one week: 286 IS, 305 DFS, and 308 QFS. The overall acceptability for the salts was QFS (82%), DFS (78%), and IS (79%). The mean sensory (taste, color and appearance) scores of the QFS (1.7) and DFS (1.7) were comparable to standard iodized salt (1.6). Conclusion Quadruple-fortified salt and double-fortified salt are equally acceptable and have similar sensory scores as standard iodized salt when used to cook commonly eaten dishes in the study population.

This paper examines changes in the completeness of documentation in clinical practice before and during the implementation of the Safer Births Bundle of Care (SBBC) project. This observational study enrolled parturient women with a gestation age of at least 28 weeks at the onset of labour. Data collectors extracted information from facility registers and then a central data manager summarised and reported weekly statistics. Variables of clinical significance for CQI were selected, and the proportion of non-documentation was analysed over time. A Pearson chi-square test was used to test for significant differences in non-documentation between the periods. Between 1 March 2021 and 31 July 2022, a total of 138,442 deliveries were recorded. Overall, 75% of all patient cases had at least one missing variable among the selected variables across both periods. A lack of variable documentation occurred more frequently at the district hospital level (81% of patient cases) and health centres (74%) than at regional referral hospitals (56%) (p < 0.001). Non-documentation decreased significantly from 79% to 70% after the introduction of the SBBC (p < 0.001). A tendency towards negative correlations was noted for most variables. We noted an increased attention to data quality and use which may have a positive impact on the completeness of documentation. However, halfway through the project’s implementation, the completeness of documentation was still low. Our findings support the recommendation to establish short-spaced feedback loops of locally collected data using one data platform.

Abstract Background Tuberculosis has remained a leading cause of death among people living with HIV (PLHIV) globally. Isoniazid preventive therapy (IPT) is the recommended strategy by the World Health Organization to prevent TB disease and related deaths among PLHIV. However, delivery and uptake of IPT has remained suboptimal particularly in countries where HIV and TB are endemic such as Tanzania. This study sought to assess contextual factors that shape delivery and uptake of IPT in Dar es Salaam region, Tanzania. Methodology We employed a qualitative case study design comprising of in-depth interviews with people living with HIV (n = 17), as well as key informant interviews with clinicians (n = 7) and health administrators (n = 7). We used thematic data analysis approach and reporting of the results was guided by the Consolidated Framework for Implementation Research (CFIR). Results Characteristics of IPT such as aligning the therapy to individual patient schedules and its relatively low cost facilitated its delivery and uptake. On the contrary, perceived adverse side effects negatively affected the delivery and uptake of IPT. Characteristics of individuals delivering the therapy including their knowledge, good attitudes, and commitment to meeting set targets facilitated the delivery and uptake of IPT. The process of IPT delivery comprised collective planning and collaboration among various facilities which facilitated its delivery and uptake. Organisational characteristics including communication among units and supportive leadership facilitated the delivery and uptake of IPT. External system factors including HIV stigma, negative cultural and religious values, limited funding as well as shortage of skilled healthcare workers presented as barriers to the delivery and uptake of IPT. Conclusion The factors influencing the delivery and uptake of IPT among people living with HIV are multifaceted and exist at different levels of the health system. Therefore, it is imperative that IPT program implementers and policy makers adopt multilevel approaches that address the identified barriers and leverage the facilitators in delivery and uptake of IPT at both community and health system levels.

Abstract Background Annually, 1.5 million intrapartum-related deaths occur; fresh stillbirths and early newborn deaths. Most of these deaths are preventable with skilled ventilation starting within the first minute of life. Helping Babies Breathe is an educational program shown to improve simulated skills in newborn resuscitation. However, translation into clinical practice remains a challenge. The aim was to describe changes in clinical resuscitation and perinatal outcomes (i.e., fresh stillbirths and 24-h newborn deaths) after introducing a novel simulator (phase 1) and then local champions (phase 2) to facilitate ongoing Helping Babies Breathe skill and scenario simulation training. Methods This is a 3-year prospective before/after (2 phases) clinical observational study in Tanzania. Research assistants observed all deliveries from September 2015 through August 2018 and recorded labor/newborn information and perinatal outcomes. A novel simulator with automatic feedback to stimulate self-guided skill training was introduced in September 2016. Local champions were introduced in October 2017 to motivate midwives for weekly training, also team simulations. Results The study included 10,481 births. Midwives had practiced self-guided skill training during the last week prior to a real newborn resuscitation in 34% of cases during baseline, 30% in phase 1, and 71% in phase 2. Most real resuscitations were provided by midwives, increasing from 66% in the baseline, to 77% in phase 1, and further to 83% in phase 2. The median time from birth to first ventilation decreased between baseline and phase 2 from 118 (85–165) to 101 (72–150) s, and time pauses during ventilation decreased from 28 to 16%. Ventilations initiated within the first minute did not change significantly (13–16%). The proportion of high-risk deliveries increased during the study period, while perinatal mortality remained unchanged. Conclusions This study reports a gradual improvement in real newborn resuscitation skills after introducing a novel simulator and then local champions. The frequency of trainings increased first after the introduction of motivating champions. Time from birth to first ventilation decreased; still, merely 16% of newborns received ventilation within the first minute as recommended. This is a remaining challenge that may require more targeted team-scenario training and quality improvement efforts to improve.

Priestia is a genus of biotechnologically important bacteria adapted to thrive in a wide range of environmental conditions including the marine sediments. Here, we screened and isolated a strain from the Bagamoyo marine mangrove-inhabited sediments and then employed whole genome sequencing to recover and define its full genome. De novo-assembly with Unicycler (v. 0.4.8) and annotation with Prokaryotic Genome Annotation Pipeline (PGAP) revealed that that its genome contains one chromosome (5,549,131 bp), with a GC content of 37.62%. Further analysis showed that the genome contains 5,687 coding sequences (CDS), 4 rRNAs, 84 tRNAs, 12 ncRNAs, and at least 2 plasmids (1,142 bp and 6,490 bp). On the other hand, antiSMASH-based secondary metabolite analysis revealed that the novel strain (MARUCO02) contains gene clusters for biosynthesis of MEP-DOXP-dependent versatile isoprenoids (eg. carotenoids), siderophores (synechobactin and schizokinen) and polyhydroxyalkanoates (PHA). The genome dataset also informs about the presence genes encoding enzymes required for generation of hopanoids, compounds that confer adaption to harsh environmental conditions including industrial cultivation recipes. Our data from this novel Priestia megaterium strain MARUCO02 can be used for reference and in genome-guided selection of strains for production of isoprenoids as well as industrially useful siderophores and polymers, amenable for biosynthetic manipulations in a biotechnological process.

Abstract Background The purpose of this project was to improve perinatal survival by introducing Moyo Fetal Heart Rate (FHR) Monitor coupled with neonatal resuscitation simulation training. Methods The implementation was done at three district hospitals. We assessed health care workers’ (HCW’s) skills and perinatal death trends during implementation. Baseline data were collected from the hospitals before implementation. Newborn resuscitation (NR) skills were assessed before and after simulation training. Assessment of perinatal outcomes was done over 2 years of implementation. We used descriptive analysis; a t-test (paired and independent two-sample) and a one-way Anova test to report the findings. Results A total of 107 HCW’s were trained on FHR monitoring using Moyo and NR knowledge and skills using NeoNatalie simulators. The knowledge increased post-training by 13.6% (p

BackgroundThe advantages of caesarean section (CS) in managing obstetric emergencies are abundant, but it is associated with several complications including surgical site infection (SSI). SSI significantly contributes to maternal morbidity and mortality rates. Mothers often do not receive adequate information about their at-home post-delivery care. Also, guidelines on post-CS care worldwide typically do not include home care recommendations. Because of the increased rate of CS and space constraints in the hospitals, mothers are often discharged home within 48 hours after CS. Therefore, it is anticipated that using an evidence-based home care guide would provide instruction to the mothers and is likely to prevent postpartum complications and promote the well-being of both the mother and the newborn.AimTo design and test the effectiveness of a post-CS home care guide in preventing SSI in central Tanzania.MethodologyThis is a sequential exploratory mixed-method interventional study conducted in two regional referral hospitals in central Tanzania. A qualitative study will be conducted to explore the experiences of nurse midwives, mothers who had caesarean deliveries and their caretakers regarding the care of mothers and newborns at home. The findings will inform the development of a post-CS home care guide. Following a series of validations of the guide, research assistants will employ the guidelines to instruct post-CS mothers about home care as part of the intervention. Thirty participants will purposively be recruited for the qualitative study and a random sample of 248 nurse-midwives and 414 post-CS mothers to assess the effectiveness of the guide in improving knowledge of home care and preventing SSI. SPSS version 25 will be used to analyse quantitative data and content analysis, and ATLAS.ti will guide in analysing the qualitative data.ConclusionThe post-CS home care guide will provide instructions to post-CS mothers and their caretakers about the care of the mothers after CS to enhance their recovery.

Abstract Background The burden of stillbirth, neonatal and maternal deaths are unacceptably high in low- and middle-income countries, especially around the time of birth. There are scarce resources and/or support implementation of evidence-based training programs. SaferBirths Bundle of Care is a well-proven package of innovative tools coupled with data-driven on-the-job training aimed at reducing perinatal and maternal deaths. The aim of this project is to determine the effect of scaling up the bundle on improving quality of intrapartum care and perinatal survival. Methods The project will follow a stepped-wedge cluster implementation design with well-established infrastructures for data collection, management, and analysis in 30 public health facilities in regions in Tanzania. Healthcare workers from selected health facilities will be trained in basic neonatal resuscitation, essential newborn care and essential maternal care. Foetal heart rate monitors (Moyo), neonatal heart rate monitors (NeoBeat) and skills trainers (NeoNatalie Live) will be introduced in the health facilities to facilitate timely identification of foetal distress during labour and improve neonatal resuscitation, respectively. Heart rate signal-data will be automatically collected by Moyo and NeoBeat, and newborn resuscitation training by NeoNatalie Live. Given an average of 4000 baby-mother pairs per year per health facility giving an estimate of 240,000 baby-mother pairs for a 2-years duration, 25% reduction in perinatal mortality at a two-sided significance level of 5%, intracluster correlation coefficient (ICC) to be 0.0013, the study power stands at 0.99. Discussion Previous reports from small-scale Safer Births Bundle implementation studies show satisfactory uptake of interventions with significant improvements in quality of care and lives saved. Better equipped and trained birth attendants are more confident and skilled in providing care. Additionally, local data-driven feedback has shown to drive continuous quality of care improvement initiatives, which is essential to increase perinatal and maternal survival. Strengths of this research project include integration of innovative tools with existing national guidelines, local data-driven decision-making and training. Limitations include the stepwise cluster implementation design that may lead to contamination of the intervention, and/or inability to address the shortage of healthcare workers and medical supplies beyond the project scope. Trial registration Name of Trial Registry: ISRCTN Registry. Trial registration number: ISRCTN30541755 . Date of Registration: 12/10/2020. Type of registration: Prospectively Registered.

Background: SaferBirths Bundle of Care (SBBC) is a package of innovative clinical and training tools coupled with low-dose high-frequency simulation-based on-job training guided by local data. This bundle of care is a new initiative being implemented in 30 health facilities from five regions of Tanzania aiming at improving birth outcomes. Objective: To assess the perception of healthcare workers and facility leaders on the “SaferBirths Bundle of Care” towards saving women’s and newborns’ lives at birth. Method: We used a qualitative approach using focused group discussion (FGD) and individual interviews. A total of 21 FGD and 43 individual interviews were conducted between August and November 2022. In total, 94 midwives and 12 doctors were involved, some of whom were in leadership roles. The framework method for the analysis of qualitative data was used for analysis. Results: Healthcare workers and facility leaders received the bundle well and regarded it as effective in saving lives and improving healthcare provision. Five themes emerged as facilitators to the acceptance of the bundle: (1) the bundle is appropriate to our needs, (2) the training modality and data use fit our context, (3) use of champions and periodic mentorship, (4) learning from our mistakes, and (5) clinical and training tools are of high quality but can be further improved. Conclusion: The relevance of SaferBirths Bundle of Care in addressing maternal and perinatal deaths, the quality and modality of training, and the culture that enhances learning from mistakes were among the facilitators of the acceptability of the SBBC. A well-accepted intervention has huge potential for bringing the intended impact in health provision.

Safer Births Bundle of Care (SBBC) consists of innovative clinical and training tools for improved labour care and newborn resuscitation, integrated with new strategies for continuous quality improvement. After implementation, we hypothesised a reduction in 24-h newborn deaths, fresh stillbirths, and maternal deaths by 50%, 20%, and 10%, respectively. This is a 3-year stepped-wedged cluster randomised implementation study, including 30 facilities within five regions in Tanzania. Data collectors at each facility enter labour and newborn care indicators, patient characteristics and outcomes. This halfway evaluation reports data from March 2021 through July 2022. In total, 138,357 deliveries were recorded; 67,690 pre- and 70,667 post-implementations of SBBC. There were steady trends of increased 24-h newborn and maternal survival in four regions after SBBC initiation. In the first region, with 13 months of implementation (n = 15,658 deliveries), an estimated additional 100 newborns and 20 women were saved. Reported fresh stillbirths seemed to fluctuate across time, and increased in three regions after the start of SBBC. Uptake of the bundle varied between regions. This SBBC halfway evaluation indicates steady reductions in 24-h newborn and maternal mortality, in line with our hypotheses, in four of five regions. Enhanced focus on uptake of the bundle and the quality improvement component is necessary to fully reach the SBBC impact potential as we move forward.

BackgroundSerious invasive infections in newborns are a major cause of death. Lack of data on etiological causes hampers progress towards reduction of mortality. This study aimed to identify pathogens responsible for such infections in young infants in sub-Saharan Africa and to describe their antibiotics resistance profile.MethodsBetween September 2016 and April 2018 we implemented an observational study in two rural sites in Burkina Faso and Tanzania enrolling young infants aged 0-59 days old with serious invasive infection. Blood samples underwent blood culture and molecular biology.ResultsIn total 634 infants with clinical diagnosis of serious invasive infection were enrolled and 4.2% of the infants had a positive blood culture. The most frequent pathogens identified by blood culture were Klebsiella pneumonia and Staphylococcus aureus, followed by Escherichia coli. Gram-negative isolates were only partially susceptible to first line WHO recommended treatment for neonatal sepsis at community level. A total of 18.6% of the infants were PCR positive for at least one pathogen and Escherichia coli and Staphylococcus aureus were the most common bacteria detected. Among infants enrolled, 60/634 (9.5%) died. Positive blood culture but not positive PCR was associated with risk of death. For most deaths, no pathogen was identified either by blood culture or molecular testing, and hence a causal agent remained unclear. Mortality was associated with low body temperature, tachycardia, respiratory symptoms, convulsions, history of difficult feeding, movement only when stimulated or reduced level of consciousness, diarrhea and/or vomiting.ConclusionWhile Klebsiella pneumonia and Staphylococcus aureus, as well as Escherichia coli were pathogens most frequently identified in infants with clinical suspicion of serious invasive infections, most cases remain without definite diagnosis, making more accurate diagnostic tools urgently needed. Antibiotics resistance to first line antibiotics is an increasing challenge even in rural Africa.

BackgroundStunting among children in low-resource settings is associated with enteric pathogen carriage and micronutrient deficiencies. Our goal was to test whether administration of scheduled antimicrobials and daily nicotinamide improved linear growth in a region with a high prevalence of stunting and enteric pathogen carriage.Methods and findingsWe performed a randomized, 2 × 2 factorial, double-blind, placebo-controlled trial in the area around Haydom, Tanzania. Mother-child dyads were enrolled by age 14 days and followed with monthly home visits and every 3-month anthropometry assessments through 18 months. Those randomized to the antimicrobial arm received 2 medications (versus corresponding placebos): azithromycin (single dose of 20 mg/kg) at months 6, 9, 12, and 15 and nitazoxanide (3-day course of 100 mg twice daily) at months 12 and 15. Those randomized to nicotinamide arm received daily nicotinamide to the mother (250 mg pills months 0 to 6) and to the child (100 mg sachets months 6 to 18). Primary outcome was length-for-age z-score (LAZ) at 18 months in the modified intention-to-treat group. Between September 5, 2017 and August 31, 2018, 1,188 children were randomized, of whom 1,084 (n = 277 placebo/placebo, 273 antimicrobial/placebo, 274 placebo/nicotinamide, and 260 antimicrobial/nicotinamide) were included in the modified intention-to-treat analysis. The study was suspended for a 3-month period by the Tanzanian National Institute for Medical Research (NIMR) because of concerns related to the timing of laboratory testing and the total number of serious adverse events (SAEs); this resulted in some participants receiving their final study assessment late. There was a high prevalence of stunting overall (533/1,084, 49.2%). Mean 18-month LAZ did not differ between groups for either intervention (mean LAZ with 95% confidence interval [CI]: antimicrobial: -2.05 CI -2.13, -1.96, placebo: -2.05 CI -2.14, -1.97; mean difference: 0.01 CI -0.13, 0.11, p = 0.91; nicotinamide: -2.06 CI -2.13, -1.95, placebo: -2.04 CI -2.14, -1.98, mean difference 0.03 CI -0.15, 0.09, p = 0.66). There was no difference in LAZ for either intervention after adjusting for possible confounders (baseline LAZ, age in days at 18-month measurement, ward, hospital birth, birth month, years of maternal education, socioeconomic status (SES) quartile category, sex, whether the mother was a member of the Datoga tribe, and mother's height). Adverse events (AEs) and SAEs were overall similar between treatment groups for both the nicotinamide and antimicrobial interventions. Key limitations include the absence of laboratory measures of pathogen carriage and nicotinamide metabolism to provide context for the negative findings.ConclusionsIn this study, we observed that neither scheduled administration of azithromycin and nitazoxanide nor daily provision of nicotinamide was associated with improved growth in this resource-poor setting with a high force of enteric infections. Further research remains critical to identify interventions toward improved early childhood growth in challenging conditions.Trial registrationClinicalTrials.gov NCT03268902.

Globally, intrapartum-related complications account for approximately 2 million perinatal deaths annually. Adequate skills in neonatal resuscitation are required to reduce perinatal mortality. NeoNatalie Live is a newborn simulator providing immediate feedback, originally designed to accomplish Helping Babies Breathe training in low-resource settings. The objectives of this study were to describe changes in staff participation, skill-training frequency, and simulated ventilation quality before and after the introduction of “local motivators” in a rural Tanzanian hospital with 4000–5000 deliveries annually. Midwives (n = 15–27) were encouraged to perform in situ low-dose high-frequency simulation skill-training using NeoNatalie Live from September 2016 through to August 2018. Frequency and quality of trainings were automatically recorded in the simulator. The number of skill-trainings increased from 688 (12 months) to 8451 (11 months) after the introduction of local motivators in October 2017. Staff participation increased from 43% to 74% of the midwives. The quality of training performance, measured as “well done” feedback, increased from 75% to 91%. We conclude that training frequency, participation, and performance increased after introduction of dedicated motivators. In addition, the immediate constructive feedback features of the simulator may have influenced motivation and training quality performance.

This paper examines changes in the completeness of documentation in clinical practice before and during the implementation of the Safer Births Bundle of Care (SBBC) project. This observational study enrolled parturient women with a gestation age of at least 28 weeks at the onset of labour. Data collectors extracted information from facility registers and then a central data manager summarised and reported weekly statistics. Variables of clinical significance for CQI were selected, and the proportion of non-documentation was analysed over time. A Pearson chi-square test was used to test for significant differences in non-documentation between the periods. Between 1 March 2021 and 31 July 2022, a total of 138,442 deliveries were recorded. Overall, 75% of all patient cases had at least one missing variable among the selected variables across both periods. A lack of variable documentation occurred more frequently at the district hospital level (81% of patient cases) and health centres (74%) than at regional referral hospitals (56%) ( p < 0.001). Non-documentation decreased significantly from 79% to 70% after the introduction of the SBBC ( p < 0.001). A tendency towards negative correlations was noted for most variables. We noted an increased attention to data quality and use which may have a positive impact on the completeness of documentation. However, halfway through the project's implementation, the completeness of documentation was still low. Our findings support the recommendation to establish short-spaced feedback loops of locally collected data using one data platform.

Introduction: Birth asphyxia-related deaths is a major global concern. Rapid initiation of ventilation within the "Golden Minute" is important for intact survival but reported to be challenging, especially in low-/middle-income countries. Helping Babies Breathe (HBB) is a simulation-based training program for newborn resuscitation. The aim of this HBB quality improvement (QI) intervention was to decrease time from birth to ventilation and document potential changes in perinatal outcomes., Method: Prospective observational QI study in a rural Tanzanian hospital, October 1, 2017, to August 31, 2021, first-year baseline, second-year QI/simulation intervention, and 2-year postintervention. Trained research assistants observed wide-ranging information from all births (N = 12,938). The intervention included monthly targeted HBB simulation training addressing documented gaps in clinical care, clinical debriefings, and feedback meetings., Results: During the QI/simulation intervention, 68.5% nonbreathing newborns were ventilated within 60 seconds after birth compared with 15.8% during baseline and 42.2% and 28.9% during the 2 postintervention years (P < 0.001). Time to first ventilation decreased from median 101 (quartiles 72-150) to 55 (45-67) seconds (P < 0.001), before increasing to 67 (49-97) and 85 (57-133) seconds after intervention. More nonbreathing newborns were ventilated in the intervention period (12.9%) compared with baseline (8.5%) and the postintervention years (10.6% and 9.4%) (P < 0.001). Assumed fresh stillborns decreased significantly from baseline to intervention (3.2%-0.7%) (P = 0.013)., Conclusions: This QI study demonstrates an increase in nonbreathing newborns being ventilated within the Golden Minute and a significant reduction in fresh stillborns after introduction of an HBB QI/simulation intervention. Improvements are partially reversed after intervention, highlighting the need for continuous simulation-based training and research into QI efforts essential for sustainable changes., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society for Simulation in Healthcare.)

Background : SaferBirths Bundle of Care (SBBC) is a package of innovative clinical and training tools coupled with low-dose high-frequency simulation-based on-job training guided by local data. This bundle of care is a new initiative being implemented in 30 health facilities from five regions of Tanzania aiming at improving birth outcomes. Objective : To assess the perception of healthcare workers and facility leaders on the "SaferBirths Bundle of Care" towards saving women's and newborns' lives at birth. Method : We used a qualitative approach using focused group discussion (FGD) and individual interviews. A total of 21 FGD and 43 individual interviews were conducted between August and November 2022. In total, 94 midwives and 12 doctors were involved, some of whom were in leadership roles. The framework method for the analysis of qualitative data was used for analysis. Results : Healthcare workers and facility leaders received the bundle well and regarded it as effective in saving lives and improving healthcare provision. Five themes emerged as facilitators to the acceptance of the bundle: (1) the bundle is appropriate to our needs, (2) the training modality and data use fit our context, (3) use of champions and periodic mentorship, (4) learning from our mistakes, and (5) clinical and training tools are of high quality but can be further improved. Conclusion : The relevance of SaferBirths Bundle of Care in addressing maternal and perinatal deaths, the quality and modality of training, and the culture that enhances learning from mistakes were among the facilitators of the acceptability of the SBBC. A well-accepted intervention has huge potential for bringing the intended impact in health provision.

Safer Births Bundle of Care (SBBC) consists of innovative clinical and training tools for improved labour care and newborn resuscitation, integrated with new strategies for continuous quality improvement. After implementation, we hypothesised a reduction in 24-h newborn deaths, fresh stillbirths, and maternal deaths by 50%, 20%, and 10%, respectively. This is a 3-year stepped-wedged cluster randomised implementation study, including 30 facilities within five regions in Tanzania. Data collectors at each facility enter labour and newborn care indicators, patient characteristics and outcomes. This halfway evaluation reports data from March 2021 through July 2022. In total, 138,357 deliveries were recorded; 67,690 pre- and 70,667 post-implementations of SBBC. There were steady trends of increased 24-h newborn and maternal survival in four regions after SBBC initiation. In the first region, with 13 months of implementation ( n = 15,658 deliveries), an estimated additional 100 newborns and 20 women were saved. Reported fresh stillbirths seemed to fluctuate across time, and increased in three regions after the start of SBBC. Uptake of the bundle varied between regions. This SBBC halfway evaluation indicates steady reductions in 24-h newborn and maternal mortality, in line with our hypotheses, in four of five regions. Enhanced focus on uptake of the bundle and the quality improvement component is necessary to fully reach the SBBC impact potential as we move forward.

Background: Clear evidence exists that perinatal audit and feedback can lead to important improvements in practice. The death audit can lead to the identification of existing potential delays which are the decision to seek medical care, reaching an appropriate facility, and receiving timely adequate care at the facility. Such an audit potentially initiates a positive discussion, which may foster the implementation of changes that aims at saving more lives., Objective: To review the perinatal deaths case notes and identify potential gaps in care provision and health-seeking behavior to foster best practice., Methods: The stillbirths and neonatal death case notes that occurred between January 2019 and May 2020 at the hospital were reviewed using an adapted WHO checklist. The completed review case notes were entered into an electronic system and a quality control check-up was done. Data were analysed descriptively, and findings were presented in tables., Results: There were 4,898 births, and 1,175 neonatal admissions, out of these there were 135 recorded stillbirths (2.8%) and 201(4.1% of the total hospital births) early neonatal deaths. Out of the 1,175 neonates, 635 (54%) were born within the hospital and 540 (46%) were admitted from other facilities and home deliveries. In total 86 stillbirths and 140 early neonatal deaths case notes were retrieved and audited. Out of 86 stillbirths' case notes audited, 30 (34.9%) seemed to have died during labor, and of these 5 had audible fetal heart rate during admission. Apgar scores less than 7 at 5 minutes, prematurity, and meconium aspiration were the top three recorded causes of neonatal deaths. Inadequate/late antenatal care visits and home delivery were the maternal factors likely to have contributed to perinatal deaths. Inadequate labor monitoring (12%) and documentation (62%) were among the providers' factors likely to have contributed to perinatal deaths., Conclusion: This audit shows that there are high rates of preventable intrapartum stillbirths and early neonatal deaths. Both women and providers' factors were found to have contributed to the stillbirths and neonatal deaths. There is a need to encourage women to adequately attend antenatal care, utilize health facilities during birth, and improve maternity and neonatal care at the health facilities., Competing Interests: There are no competing interests to declare by all authors.

Background: Serious invasive infections in newborns are a major cause of death. Lack of data on etiological causes hampers progress towards reduction of mortality. This study aimed to identify pathogens responsible for such infections in young infants in sub-Saharan Africa and to describe their antibiotics resistance profile., Methods: Between September 2016 and April 2018 we implemented an observational study in two rural sites in Burkina Faso and Tanzania enrolling young infants aged 0-59 days old with serious invasive infection. Blood samples underwent blood culture and molecular biology., Results: In total 634 infants with clinical diagnosis of serious invasive infection were enrolled and 4.2% of the infants had a positive blood culture. The most frequent pathogens identified by blood culture were Klebsiella pneumonia and Staphylococcus aureus, followed by Escherichia coli. Gram-negative isolates were only partially susceptible to first line WHO recommended treatment for neonatal sepsis at community level. A total of 18.6% of the infants were PCR positive for at least one pathogen and Escherichia coli and Staphylococcus aureus were the most common bacteria detected. Among infants enrolled, 60/634 (9.5%) died. Positive blood culture but not positive PCR was associated with risk of death. For most deaths, no pathogen was identified either by blood culture or molecular testing, and hence a causal agent remained unclear. Mortality was associated with low body temperature, tachycardia, respiratory symptoms, convulsions, history of difficult feeding, movement only when stimulated or reduced level of consciousness, diarrhea and/or vomiting., Conclusion: While Klebsiella pneumonia and Staphylococcus aureus, as well as Escherichia coli were pathogens most frequently identified in infants with clinical suspicion of serious invasive infections, most cases remain without definite diagnosis, making more accurate diagnostic tools urgently needed. Antibiotics resistance to first line antibiotics is an increasing challenge even in rural Africa., Competing Interests: The authors have declared that no competing interests exist.

Globally, intrapartum-related complications account for approximately 2 million perinatal deaths annually. Adequate skills in neonatal resuscitation are required to reduce perinatal mortality. NeoNatalie Live is a newborn simulator providing immediate feedback, originally designed to accomplish Helping Babies Breathe training in low-resource settings. The objectives of this study were to describe changes in staff participation, skill-training frequency, and simulated ventilation quality before and after the introduction of "local motivators" in a rural Tanzanian hospital with 4000-5000 deliveries annually. Midwives ( n = 15-27) were encouraged to perform in situ low-dose high-frequency simulation skill-training using NeoNatalie Live from September 2016 through to August 2018. Frequency and quality of trainings were automatically recorded in the simulator. The number of skill-trainings increased from 688 (12 months) to 8451 (11 months) after the introduction of local motivators in October 2017. Staff participation increased from 43% to 74% of the midwives. The quality of training performance, measured as "well done" feedback, increased from 75% to 91%. We conclude that training frequency, participation, and performance increased after introduction of dedicated motivators. In addition, the immediate constructive feedback features of the simulator may have influenced motivation and training quality performance.

Objectives: Disrespectful care, which remains prevalent in low and middle-income countries (LMICs), acts as a barrier to women accessing skilled birth attendance, compromising care when services are available. Building on what was positive in facilities, we aimed to explore lay and healthcare providers' experience of respectful care to inform future interventions., Setting: Five maternity facilities in Mwanza Tanzania and Lilongwe Malawi., Participants: 94 participants in Malawi (N=46) and Tanzania (N=48) including 24 women birthing live baby within the previous 12 months; 22 family members and 48 healthcare providers who regularly provided maternity care in the included facilities DESIGN: The study was guided by Appreciative Inquiry (AI). Semistructured, one-to-one interviews were conducted between January and December 2019. Interviews were audio-recorded, translated where necessary, transcribed verbatim, and analysed using the framework approach., Results: Four main themes describing participants positive experience and their vision of respectful care were identified: (1) empathic healthcare provider-woman interactions including friendly welcome and courteous language, well-timed appropriate care and information sharing, (2) an enabling environment, characterised by improvement of physical environment, the use of screens, curtains and wall partitions for privacy, availability of equipment and provision of incentives to staff, (3) supportive leadership demonstrated by the commitment of the government and facility leaders to provision of respectful care, ensuring availability of guidelines and policies, supportive supervision, reflective discussion and paying staff salaries timely, (4) providers' attitudes and behaviours characterised by professional values through readiness, compassionate communication and commitment., Conclusion: The positive experiences of service users, families and healthcare providers provided insight into key drivers of respectful care in facilities in Tanzania and Malawi. Interventions targeting improved environment and privacy, healthcare provider communication and developing positive leadership structures in facilities could provide the basis for sustained improvement in respectful and dignified maternal and newborn care in LMICs., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Stunting among children in low-resource settings is associated with enteric pathogen carriage and micronutrient deficiencies. Our goal was to test whether administration of scheduled antimicrobials and daily nicotinamide improved linear growth in a region with a high prevalence of stunting and enteric pathogen carriage., Methods and Findings: We performed a randomized, 2 × 2 factorial, double-blind, placebo-controlled trial in the area around Haydom, Tanzania. Mother-child dyads were enrolled by age 14 days and followed with monthly home visits and every 3-month anthropometry assessments through 18 months. Those randomized to the antimicrobial arm received 2 medications (versus corresponding placebos): azithromycin (single dose of 20 mg/kg) at months 6, 9, 12, and 15 and nitazoxanide (3-day course of 100 mg twice daily) at months 12 and 15. Those randomized to nicotinamide arm received daily nicotinamide to the mother (250 mg pills months 0 to 6) and to the child (100 mg sachets months 6 to 18). Primary outcome was length-for-age z-score (LAZ) at 18 months in the modified intention-to-treat group. Between September 5, 2017 and August 31, 2018, 1,188 children were randomized, of whom 1,084 (n = 277 placebo/placebo, 273 antimicrobial/placebo, 274 placebo/nicotinamide, and 260 antimicrobial/nicotinamide) were included in the modified intention-to-treat analysis. The study was suspended for a 3-month period by the Tanzanian National Institute for Medical Research (NIMR) because of concerns related to the timing of laboratory testing and the total number of serious adverse events (SAEs); this resulted in some participants receiving their final study assessment late. There was a high prevalence of stunting overall (533/1,084, 49.2%). Mean 18-month LAZ did not differ between groups for either intervention (mean LAZ with 95% confidence interval [CI]: antimicrobial: -2.05 CI -2.13, -1.96, placebo: -2.05 CI -2.14, -1.97; mean difference: 0.01 CI -0.13, 0.11, p = 0.91; nicotinamide: -2.06 CI -2.13, -1.95, placebo: -2.04 CI -2.14, -1.98, mean difference 0.03 CI -0.15, 0.09, p = 0.66). There was no difference in LAZ for either intervention after adjusting for possible confounders (baseline LAZ, age in days at 18-month measurement, ward, hospital birth, birth month, years of maternal education, socioeconomic status (SES) quartile category, sex, whether the mother was a member of the Datoga tribe, and mother's height). Adverse events (AEs) and SAEs were overall similar between treatment groups for both the nicotinamide and antimicrobial interventions. Key limitations include the absence of laboratory measures of pathogen carriage and nicotinamide metabolism to provide context for the negative findings., Conclusions: In this study, we observed that neither scheduled administration of azithromycin and nitazoxanide nor daily provision of nicotinamide was associated with improved growth in this resource-poor setting with a high force of enteric infections. Further research remains critical to identify interventions toward improved early childhood growth in challenging conditions., Trial Registration: ClinicalTrials.gov NCT03268902., Competing Interests: The authors have declared that no competing interests exist.