Direct maternal morbidity and the risk of pregnancy-related deaths, stillbirths, and neonatal deaths in South Asia and sub-Saharan Africa: A population-based prospective cohort study in 8 countries.

BACKGROUND: Maternal morbidity occurs several times more frequently than mortality, yet data on morbidity burden and its effect on maternal, foetal, and newborn outcomes are limited in low- and middle-income countries. We aimed to generate prospective, reliable population-based data on the burden of major direct maternal morbidities in the antenatal, intrapartum, and postnatal periods and its association with maternal, foetal, and neonatal death in South Asia and sub-Saharan Africa. METHODS AND FINDINGS: This is a prospective cohort study, conducted in 9 research sites in 8 countries of South Asia and sub-Saharan Africa. We conducted population-based surveillance of women of reproductive age (15 to 49 years) to identify pregnancies. Pregnant women who gave consent were include in the study and followed up to birth and 42 days postpartum from 2012 to 2015. We used standard operating procedures, data collection tools, and training to harmonise study implementation across sites. Three home visits during pregnancy and 2 home visits after birth were conducted to collect maternal morbidity information and maternal, foetal, and newborn outcomes. We measured blood pressure and proteinuria to define hypertensive disorders of pregnancy and woman's self-report to identify obstetric haemorrhage, pregnancy-related infection, and prolonged or obstructed labour. Enrolled women whose pregnancy lasted at least 28 weeks or those who died during pregnancy were included in the analysis. We used meta-analysis to combine site-specific estimates of burden, and regression analysis combining all data from all sites to examine associations between the maternal morbidities and adverse outcomes. Among approximately 735,000 women of reproductive age in the study population, and 133,238 pregnancies during the study period, only 1.6% refused consent. Of these, 114,927 pregnancies had morbidity data collected at least once in both antenatal and in postnatal period, and 114,050 of them were included in the analysis. Overall, 32.7% of included pregnancies had at least one major direct maternal morbidity; South Asia had almost double the burden compared to sub-Saharan Africa (43.9%, 95% CI 27.8% to 60.0% in South Asia; 23.7%, 95% CI 19.8% to 27.6% in sub-Saharan Africa). Antepartum haemorrhage was reported in 2.2% (95% CI 1.5% to 2.9%) pregnancies and severe postpartum in 1.7% (95% CI 1.2% to 2.2%) pregnancies. Preeclampsia or eclampsia was reported in 1.4% (95% CI 0.9% to 2.0%) pregnancies, and gestational hypertension alone was reported in 7.4% (95% CI 4.6% to 10.1%) pregnancies. Prolonged or obstructed labour was reported in about 11.1% (95% CI 5.4% to 16.8%) pregnancies. Clinical features of late third trimester antepartum infection were present in 9.1% (95% CI 5.6% to 12.6%) pregnancies and those of postpartum infection in 8.6% (95% CI 4.4% to 12.8%) pregnancies. There were 187 pregnancy-related deaths per 100,000 births, 27 stillbirths per 1,000 births, and 28 neonatal deaths per 1,000 live births with variation by country and region. Direct maternal morbidities were associated with each of these outcomes. CONCLUSIONS: Our findings imply that health programmes in sub-Saharan Africa and South Asia must intensify their efforts to identify and treat maternal morbidities, which affected about one-third of all pregnancies and to prevent associated maternal and neonatal deaths and stillbirths. TRIAL REGISTRATION: The study is not a clinical trial.

Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa.

INTRODUCTION: Serious bacterial neonatal infections are a major cause of global neonatal mortality. While hospitalized treatment is recommended, families cannot access inpatient treatment in low resource settings. Two parallel randomized control trials were conducted at five sites in three countries (Democratic Republic of Congo, Kenya, and Nigeria) to compare the effectiveness of treatment with experimental regimens requiring fewer injections with a reference regimen A (injection gentamicin plus injection procaine penicillin both once daily for 7 days) on the outpatient basis provided to young infants (0-59 days) with signs of possible serious bacterial infection (PSBI) when the referral was not feasible. Costs were estimated to quantify the financial implications of scaleup, and cost-effectiveness of these regimens. METHODS: Direct economic costs (including personnel, drugs and consumable costs) were estimated for identification, prenatal and postnatal visits, assessment, classification, treatment and follow-up. Data on time spent by providers on each activity was collected from 83% of providers. Indirect marginal financial costs were estimated for non-consumables/capital, training, transport, communication, administration and supervision by considering only a share of the total research and health system costs considered important for the program. Total economic costs (direct plus indirect) per young infant treated were estimated based on 39% of young infants enrolled in the trial during 2012 and the number of days each treated during one year. The incremental cost-effectiveness ratio was calculated using treatment failure after one week as the outcome indicator. Experimental regimens were compared to the reference regimen and pairwise comparisons were also made. RESULTS: The average costs of treating a young infant with clinical severe infection (a sub-category of PSBI) in 2012 was lowest with regimen D (injection gentamicin once daily for 2 days plus oral amoxicillin twice daily for 7 days) at US$ 20.9 (95% CI US$ 16.4-25.3) or US$ 32.5 (2018 prices). While all experimental regimens B (injection gentamicin once daily plus oral amoxicillin twice daily, both for 7 days), regimen C (once daily of injection gentamicin injection plus injection procaine penicillin for 2 days, thereafter oral amoxicillin twice daily for 5 days) and regimen D were found to be more cost-effective as compared with the reference regimen A; pairwise comparison showed regimen D was more cost-effective than B or C. For fast breathing, the average cost of treatment with regimen E (oral amoxicillin twice daily for 7 days) at US$ 18.3 (95% CI US$ 13.4-23.3) or US$ 29.0 (2018 prices) was more cost-effective than regimen A. Indirect costs were 32% of the total treatment costs. CONCLUSION: Scaling up of outpatient treatment for PSBI when the referral is not feasible with fewer injections and oral antibiotics is cost-effective for young infants and can lead to increased access to treatment resulting in potential reductions in neonatal mortality. CLINICAL TRIAL REGISTRATION: The trial was registered with Australian New Zealand Clinical Trials Registry under ID ACTRN 12610000286044.

Practice and outcomes of neonatal resuscitation for newborns with birth asphyxia at Kakamega County General Hospital, Kenya: a direct observation study.

BACKGROUND: About three - quarters of all neonatal deaths occur during the first week of life, with over half of these occurring within the first 24 h after birth. The first minutes after birth are critical to reducing neonatal mortality. Successful neonatal resuscitation (NR) has the potential to prevent these perinatal mortalities related to birth asphyxia. This study described the practice of NR and outcomes of newborns with birth asphyxia in a busy referral hospital. METHODS: Direct observations of 138 NRs by 28 healthcare providers (HCPs) were conducted using a predetermined checklist adapted from the national pediatric resuscitation protocol. Descriptive statistics were computed and chi - square tests were used to test associations between the newborn outcome at 1 h and the NR processes for the observed newborns. Logistic regression models assessed the relationship between the survival status at 1 h versus the NR processes and newborn characteristics. RESULTS: Nurses performed 72.5% of the NRs. A warm environment was maintained in 71% of the resuscitations. Airway was checked for almost all newborns (98%) who did not initiate spontaneous breathing after stimulation. However, only 40% of newborns were correctly cared for in case of meconium presence in airway. Bag and mask ventilation (BMV) was initiated in 100% of newborns who did not respond to stimulation and airway maintenance. About 86.2% of resuscitated newborns survived after 1 h. Removing wet cloth (P = 0.035, OR = 2.90, CI = 1.08-7.76), keeping baby warm (P = 0.018, OR = 3.30, CI = 1.22-8.88), meconium in airway (P = 0.042, OR = 0.34, CI = 0.12-0.96) and gestation age (P = 0.007, OR = 1.38, CI = 1.10-1.75) were associated with newborn outcome at 1 h. CONCLUSIONS: Mentorship and regular cost - effective NR trainings with focus on maintaining the warm chain during NR, airway maintenance in meconium presence, BMV and care for premature babies are needed for HCPs providing NR.

Quality of Care during Neonatal Resuscitation in Kakamega County General Hospital, Kenya: A Direct Observation Study.

BACKGROUND: Birth asphyxia is the leading cause of neonatal mortality in Kenya. Quality care during neonatal resuscitation (NR) can contribute to a reduction in neonatal mortality related to birth asphyxia by 30 percent. This study assessed the quality of care (QoC) during NR for newborns with birth asphyxia. METHODS: Direct observations of 138 newborn resuscitations were done in labor ward and maternity theatre. Twenty-eight healthcare providers were observed 3-5 times using a structured checklist. Descriptive and inferential statistics were calculated and quality of care scores computed. Ordered logistic regression model identified HCPs characteristics associated with the QoC scores during NR. RESULTS: Overall QoC scores were good for airway clearance (83%). Suctioning in meconium presence (40%) was poorly performed. Years of experience working in maternity were associated with good drying/stimulation (ß = 1.86, P = 0.003, CI = 0.626-3.093) and airway maintenance (ß = 1.887, P = 0.009, CI = 0.469-3.305); nurses were poor compared to doctors during initial bag and mask ventilation (ß = -2.338, P = 0.05, CI = -4.732-0.056). CONCLUSION: Key steps in NR are poorly performed during drying and warmth, airway maintenance in meconium presence, and ventilation. Mentorship with periodic refresher training can improve the care provided during NR.

Sexual Behavior Among Orphaned Adolescents in Western Kenya: A Comparison of Institutional- and Family-Based Care Settings.

PURPOSE: This study sought to assess whether risky sexual behaviors and sexual exploitation of orphaned adolescents differed between family-based and institutional care environments in Uasin Gishu County, Kenya. METHODS: We analyzed baseline data from a cohort of orphaned adolescents aged 10-18 years living in 300 randomly selected households and 19 charitable children's institutions. The primary outcomes were having ever had consensual sex, number of sex partners, transactional sex, and forced sex. Multivariate logistic regression compared these between participants in institutional care and family-based care while adjusting for age, sex, orphan status, importance of religion, caregiver support and supervision, school attendance, and alcohol and drug use. RESULTS: This analysis included 1,365 participants aged ≥10 years: 712 (52%) living in institutional environments and 653 (48%) in family-based care. Participants in institutional care were significantly less likely to report engaging in transactional sex (adjusted odds ratio, .46; 95% confidence interval, .3-.72) or to have experienced forced sex (adjusted odds ratio, .57; 95% confidence interval, .38-.88) when controlling for age, sex, and orphan status. These associations remained when adjusting for additional variables. CONCLUSIONS: Orphaned adolescents living in family-based care in Uasin Gishu, Kenya, may be at increased risk of transactional sex and sexual violence compared to those in institutional care. Institutional care may reduce vulnerabilities through the provision of basic material needs and adequate standards of living that influence adolescents' sexual risk-taking behaviors. The use of single items to assess outcomes and nonexplicit definition of sex suggest the findings should be interpreted with caution.

Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time?

BACKGROUND: The first minutes after birth are critical to reducing neonatal mortality. Helping Babies Breathe (HBB) is a simulation-based neonatal resuscitation program for low resource settings. We studied the impact of initial HBB training followed by refresher training on the knowledge and skills of the birth attendants in facilities. METHODS: We conducted HBB trainings in 71 facilities in the NICHD Global Network research sites (Nagpur and Belgaum, India and Eldoret, Kenya), with a 6:1 ratio of facility trainees to Master Trainers (MT). Because of staff turnover, some birth attendants (BA) were trained as they joined the delivery room staff, after the initial training was completed (catch-up initial training). We compared pass rates for skills and knowledge pre- and post- initial HBB training and following refresher training among active BAs. An Objective Structured Clinical Examination (OSCE) B tested resuscitation skill retention by comparing post-initial training performance with pre-refresher training performance. We identified factors associated with loss of skills in pre-refresher training performance using multivariable logistic regression analysis. Daily bag and mask ventilation practice, equipment checks and supportive supervision were stressed as part of training. RESULTS: One hundred five MT (1.6 MT per facility) conducted initial and refresher HBB trainings for 835 BAs; 76% had no prior resuscitation training. Initial training improved knowledge and skills: the pass percentage for knowledge tests improved from 74 to 99% (p < 0.001). Only 5% could ventilate a newborn mannequin correctly before initial training but 97% passed the post-initial ventilation training test (p < 0.0001) and 99% passed the OSCE B resuscitation evaluation. During pre-refresher training evaluation, a mean of 6.7 (SD 2.49) months after the initial training, 99% passed the knowledge test, but the successful completion rate fell to 81% for the OSCE B resuscitation skills test. Characteristics associated with deterioration of resuscitation skills were BAs from tertiary care facilities, no prior resuscitation training, and the timing of training (initial vs. catch-up training). CONCLUSIONS: HBB training significantly improved neonatal resuscitation knowledge and skills. However, skills declined more than knowledge over time. Ongoing skills practice and monitoring, more frequent retesting, and refresher trainings are needed to maintain neonatal resuscitation skills. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01681017 ; 04 September 2012, retrospectively registered.

A pre-post study of a multi-country scale up of resuscitation training of facility birth attendants: does Helping Babies Breathe training save lives?

BACKGROUND: Whether facility-based implementation of Helping Babies Breathe (HBB) reduces neonatal mortality at a population level in low and middle income countries (LMIC) has not been studied. Therefore, we evaluated HBB implementation in this context where our study team has ongoing prospective outcome data on all pregnancies regardless of place of delivery. METHODS: We compared outcomes of birth cohorts in three sites in India and Kenya pre-post implementation of a facility-based intervention, using a prospective, population-based registry in 52 geographic clusters. Our hypothesis was that HBB implementation would result in a 20 % decrease in the perinatal mortality rate (PMR) among births ≥1500 g. RESULTS: We enrolled 70,704 births during two 12-month study periods. Births within each site did not differ pre-post intervention, except for an increased proportion of <2500 g newborns and deliveries by caesarean section in the post period. There were no significant differences in PMR among all registry births; however, a post-hoc analysis stratified by birthweight documented improvement in <2500 g mortality in Belgaum in both registry and in HBB-trained facility births. No improvement in <2500 g mortality measures was noted in Nagpur or Kenya and there was no improvement in normal birth weight survival. CONCLUSIONS: Rapid scale up of HBB training of facility birth attendants in three diverse sites in India and Kenya was not associated with consistent improvements in mortality among all neonates ≥1500 g; however, differential improvements in <2500 g survival in Belgaum suggest the need for careful implementation of HBB training with attention to the target population, data collection, and ongoing quality monitoring activities. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov: NCT01681017 .

Self-reported practices among traditional birth attendants surveyed in western Kenya: a descriptive study.

BACKGROUND: The high rate of home deliveries conducted by unskilled birth attendants in resource-limited settings is an important global health issue because it is believed to be a significant contributing factor to maternal and newborn mortality. Given the large number of deliveries that are managed by unskilled or traditional birth attendants outside of health facilities, and the fact that there is on-going discussion regarding the role of traditional birth attendants in the maternal newborn health (MNH) service continuum, we sought to ascertain the practices of traditional birth attendants in our catchment area. The findings of this descriptive study might help inform conversations regarding the roles that traditional birth attendants can play in maternal-newborn health care. METHODS: A structured questionnaire was used in a survey that included one hundred unskilled birth attendants in western Kenya. Descriptive statistics were employed. RESULTS: Inappropriate or outdated practices were reported in relation to some obstetric complications and newborn care. Encouraging results were reported with regard to positive relationships that traditional birth attendants have with their local health facilities. Furthermore, high rates of referral to health facilities was reported for many common obstetric emergencies and similar rates for reporting of pregnancy outcomes to village elders and chiefs. CONCLUSIONS: Potentially harmful or outdated practices with regard to maternal and newborn care among traditional birth attendants in western Kenya were revealed by this study. There were high rates of traditional birth attendant referrals of pregnant mothers with obstetric complications to health facilities. Policy makers may consider re-educating and re-defining the roles and responsibilities of traditional birth attendants in maternal and neonatal health care based on the findings of this survey.

Setting research priorities to improve global newborn health and prevent stillbirths by 2025.

BACKGROUND: In 2013, an estimated 2.8 million newborns died and 2.7 million were stillborn. A much greater number suffer from long term impairment associated with preterm birth, intrauterine growth restriction, congenital anomalies, and perinatal or infectious causes. With the approaching deadline for the achievement of the Millennium Development Goals (MDGs) in 2015, there was a need to set the new research priorities on newborns and stillbirth with a focus not only on survival but also on health, growth and development. We therefore carried out a systematic exercise to set newborn health research priorities for 2013-2025. METHODS: We used adapted Child Health and Nutrition Research Initiative (CHNRI) methods for this prioritization exercise. We identified and approached the 200 most productive researchers and 400 program experts, and 132 of them submitted research questions online. These were collated into a set of 205 research questions, sent for scoring to the 600 identified experts, and were assessed and scored by 91 experts. RESULTS: Nine out of top ten identified priorities were in the domain of research on improving delivery of known interventions, with simplified neonatal resuscitation program and clinical algorithms and improved skills of community health workers leading the list. The top 10 priorities in the domain of development were led by ideas on improved Kangaroo Mother Care at community level, how to improve the accuracy of diagnosis by community health workers, and perinatal audits. The 10 leading priorities for discovery research focused on stable surfactant with novel modes of administration for preterm babies, ability to diagnose fetal distress and novel tocolytic agents to delay or stop preterm labour. CONCLUSION: These findings will assist both donors and researchers in supporting and conducting research to close the knowledge gaps for reducing neonatal mortality, morbidity and long term impairment. WHO, SNL and other partners will work to generate interest among key national stakeholders, governments, NGOs, and research institutes in these priorities, while encouraging research funders to support them. We will track research funding, relevant requests for proposals and trial registers to monitor if the priorities identified by this exercise are being addressed.

Simplified antibiotic regimens compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with clinical signs of possible serious bacterial infection when referral is not possible: a randomised, open-label, equivalence trial.

BACKGROUND: WHO recommends hospital-based treatment for young infants aged 0-59 days with clinical signs of possible serious bacterial infection, but most families in resource-poor settings cannot accept referral. We aimed to assess whether use of simplified antibiotic regimens to treat young infants with clinical signs of severe infection was as efficacious as an injectable procaine benzylpenicillin-gentamicin combination for 7 days for situations in which hospital referral was not possible. METHODS: In a multisite open-label equivalence trial in DR Congo, Kenya, and Nigeria, community health workers visited all newborn babies at home, identifying and referring unwell young infants to a study nurse. We stratified young infants with clinical signs of severe infection whose parents did not accept referral to hospital by age (0-6 days and 7-59 days), and randomly assigned each individual within these strata to receive one of the four treatment regimens. Randomisation was stratified by age group of infants. An age-stratified randomisation scheme with block size of eight was computer-generated off-site at WHO. The outcome assessor was masked. We randomly allocated infants to receive injectable procaine benzylpenicillin-gentamicin for 7 days (group A, reference group); injectable gentamicin and oral amoxicillin for 7 days (group B); injectable procaine benzylpenicillin-gentamicin for 2 days, then oral amoxicillin for 5 days (group C); or injectable gentamicin for 2 days and oral amoxicillin for 7 days (group D). Trained health professionals gave daily injections and the first dose of oral amoxicillin. Our primary outcome was treatment failure by day 8 after enrolment, defined as clinical deterioration, development of a serious adverse event (including death), no improvement by day 4, or not cured by day 8. Independent outcome assessors, who did not know the infant's treatment regimen, assessed study outcomes on days 4, 8, 11, and 15. Primary analysis was per protocol. We used a prespecified similarity margin of 5% to assess equivalence between regimens. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12610000286044. FINDINGS: In Kenya and Nigeria, we started enrolment on April 4, 2011, and we enrolled the necessary number of young infants aged 7 days or older from Oct 17, 2011, to April 30, 2012. At these sites, we continued to enrol infants younger than 7 days until March 29, 2013. In DR Congo, we started enrolment on Sept 17, 2012, and continued until June 28, 2013. We randomly assigned 3564 young infants to either group A (n=894), group B (n=884), group C (n=896), or group D (n=890). We excluded 200 randomly assigned infants, who did not fulfil the predefined criteria of adherence to treatment and adequate follow-up. In the per-protocol analysis, 828 infants were included in group A, 826 in group B, 862 in group C, and 848 in group D. 67 (8%) infants failed treatment in group A compared with 51 (6%) infants in group B (risk difference -1·9%, 95% CI -4·4 to 0·1), 65 (8%) in group C (-0·6%, -3·1 to 2·0), and 46 (5%) in group D (-2·7%, -5·1 to 0·3). Treatment failure in groups B, C, and D was within the similarity margin compared with group A. During the 15 days after random allocation, 12 (1%) infants died in group A, compared with ten (1%) infants in group B, 20 (2%) infants in group C, and 11 (1%) infants in group D. An infant in group A had a serious adverse event other than death (injection abscess). INTERPRETATION: The three simplified regimens were as effective as injectable procaine benzylpenicillin-gentamicin for 7 days on an outpatient basis in young infants with clinical signs of severe infection, without signs of critical illness, and whose caregivers did not accept referral for hospital admission. FUNDING: Bill & Melinda Gates Foundation grant to WHO.

Oral amoxicillin compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with fast breathing when referral is not possible: a randomised, open-label, equivalence trial.

BACKGROUND: WHO recommends referral to hospital for possible serious bacterial infection in young infants aged 0-59 days. We aimed to assess whether oral amoxicillin treatment for fast breathing, in the absence of other signs, is as efficacious as the combination of injectable procaine benzylpenicillin-gentamicin. METHODS: In a randomised, open-label, equivalence trial at five sites in DR Congo, Kenya, and Nigeria, community health workers followed up all births in the community, identified unwell young infants, and referred them to study nurses. We randomly assigned infants with fast breathing as a single sign of illness or possible serious bacterial infection, whose parents did not accept referral to hospital, to receive either injectable procaine benzylpenicillin-gentamicin once per day or oral amoxicillin treatment twice per day for 7 days. A person who was off-site generated randomisation lists using computer software. Trained health professionals gave injections, but outcome assessors were masked to group allocations. The primary outcome was treatment failure by day 8 after enrolment, defined as clinical deterioration, development of a serious adverse event including death, persistence of fast breathing on day 4, or recurrence up to day 8. The primary analysis was per protocol and we used a prespecified similarity margin of 5% to assess equivalence between regimens. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12610000286044. FINDINGS: From April 4, 2011, to March 29, 2013, we enrolled 2333 infants aged 0-59 days with fast breathing as the only sign of possible serious bacterial infection at the five study sites. We assigned 1170 infants to receive injectable procaine benzylpenicillin-gentamicin and 1163 infants to receive oral amoxicillin. In the per-protocol analysis, from which 137 infants were excluded, we included 1061 (91%) infants who fulfilled predefined criteria of adherence to treatment and adequate follow-up in the injectable procaine benzylpenicillin-gentamicin group and 1145 (98%) infants in the oral amoxicillin group. In the procaine benzylpenicillin-gentamicin group, 234 infants (22%) failed treatment, compared with 221 (19%) infants in the oral amoxicillin group (risk difference -2·6%, 95% CI -6·0 to 0·8). Four infants died within 15 days of follow-up in each group. We detected no drug-related serious adverse events. INTERPRETATION: Young infants with fast breathing alone can be effectively treated with oral amoxicillin on an outpatient basis when referral to a hospital is not possible. FUNDING: Bill & Melinda Gates Foundation grant to WHO.

Procedural pain in neonatal units in Kenya.

OBJECTIVES: To determine the nature and frequency of painful procedures and procedural pain management practices in neonatal units in Kenya. DESIGN: Cross-sectional survey. SETTING: Level I and level II neonatal units in Kenya. PATIENTS: Ninety-five term and preterm neonates from seven neonatal units. METHODS: Medical records of neonates admitted for at least 24 h were reviewed to determine the nature and frequency of painful procedures performed in the 24 h period preceding data collection (6:00 to 6:00) as well as the pain management interventions (eg, morphine, breastfeeding, skin-to-skin contact, containment, non-nutritive sucking) that accompanied each procedure. RESULTS: Neonates experienced a total of 404 painful procedures over a 24 h period (mean=4.3, SD 2.0; range 1-12); 270 tissue-damaging (mean=2.85, SD 1.1; range 1-6) and 134 non-tissue-damaging procedures (mean=1.41, SD 1.2; range 0-6). Peripheral cannula insertion (27%) and intramuscular injections (22%) were the most common painful procedures. Ventilated neonates and neonates admitted in level II neonatal units had a higher number of painful procedures than those admitted in level I units (mean 4.76 vs 2.96). Only one procedure had a pain intensity score documented; and none had been performed with any form of analgesia. CONCLUSIONS: Neonates in Kenya were exposed to numerous tissue-damaging and non-tissue-damaging procedures without any form of analgesia. Our findings suggest that education is needed on how to assess and manage procedural pain in neonatal units in Kenya.

Models of care for orphaned and separated children and upholding children's rights: cross-sectional evidence from western Kenya.

BACKGROUND: Sub-Saharan Africa is home to approximately 55 million orphaned children. The growing orphan crisis has overwhelmed many communities and has weakened the ability of extended families to meet traditional care-taking expectations. Other models of care and support have emerged in sub-Saharan Africa to address the growing orphan crisis, yet there is a lack of information on these models available in the literature. We applied a human rights framework using the United Nations Convention on the Rights of the Child to understand what extent children's basic human rights were being upheld in institutional vs. community- or family-based care settings in Uasin Gishu County, Kenya. METHODS: The Orphaned and Separated Children's Assessments Related to their Health and Well-Being Project is a 5-year cohort of orphaned children and adolescents aged ≤18 year. This descriptive analysis was restricted to baseline data. Chi-Square test was used to test for associations between categorical /dichotomous variables. Fisher's exact test was also used if some cells had expected value of less than 5. RESULTS: Included in this analysis are data from 300 households, 19 Charitable Children's Institutions (CCIs) and 7 community-based organizations. In total, 2871 children were enrolled and had baseline assessments done: 1390 in CCI's and 1481 living in households in the community. We identified and described four broad models of care for orphaned and separated children, including: institutional care (sub-classified as 'Pure CCI' for those only providing residential care, 'CCI-Plus' for those providing both residential care and community-based supports to orphaned children , and 'CCI-Shelter' which are rescue, detention, or other short-term residential support), family-based care, community-based care and self-care. Children in institutional care (95%) were significantly (p < 0.0001) more likely to have their basic material needs met in comparison to those in family-based care (17%) and institutions were better able to provide an adequate standard of living. CONCLUSIONS: Each model of care we identified has strengths and weaknesses. The orphan crisis in sub-Saharan Africa requires a diversity of care environments in order to meet the needs of children and uphold their rights. Family-based care plays an essential role; however, households require increased support to adequately care for children.

Implementation and evaluation of the Helping Babies Breathe curriculum in three resource limited settings: does Helping Babies Breathe save lives? A study protocol.

BACKGROUND: Neonatal deaths account for over 40% of all under-5 year deaths; their reduction is increasingly critical for achieving Millennium Development Goal 4. An estimated 3 million newborns die annually during their first month of life; half of these deaths occur during delivery or within 24 hours. Every year, 6 million babies require help to breathe immediately after birth. Resuscitation training to help babies breathe and prevent/manage birth asphyxia is not routine in low-middle income facility settings. Helping Babies Breathe (HBB), a simulation-training program for babies wherever they are born, was developed for use in low-middle income countries. We evaluated whether HBB training of facility birth attendants reduces perinatal mortality in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Global Network research sites. METHODS/DESIGN: We hypothesize that a two-year prospective pre-post study to evaluate the impact of a facility-based training package, including HBB and essential newborn care, will reduce all perinatal mortality (fresh stillbirth or neonatal death prior to 7 days) among the Global Network's Maternal Neonatal Health Registry births ≥1500 grams in the study clusters served by the facilities. We will also evaluate the effectiveness of the HBB training program changing on facility-based perinatal mortality and resuscitation practices. Seventy-one health facilities serving 52 geographically-defined study clusters in Belgaum and Nagpur, India, and Eldoret, Kenya, and 30,000 women will be included. Primary outcome data will be collected by staff not involved in the HBB intervention. Additional data on resuscitations, resuscitation debriefings, death audits, quality monitoring and improvement will be collected. HBB training will include training of MTs, facility level birth attendants, and quality monitoring and improvement activities. DISCUSSION: Our study will evaluate the effect of a HBB/ENC training and quality monitoring and improvement package on perinatal mortality using a large multicenter design and approach in 71 resource-limited health facilities, leveraging an existing birth registry to provide neonatal outcomes through day 7. The study will provide the evidence base, lessons learned, and best practices that will be essential to guiding future policy and investment in neonatal resuscitation. TRIAL REGISTRATION: Trial registration ClinicalTrials.gov Identifier: NCT01681017.

Scientific rationale for study design of community-based simplified antibiotic therapy trials in newborns and young infants with clinically diagnosed severe infections or fast breathing in South Asia and sub-Saharan Africa.

BACKGROUND: Newborns and young infants suffer high rates of infections in South Asia and sub-Saharan Africa. Timely access to appropriate antibiotic therapy is essential for reducing mortality. In an effort to develop community case management guidelines for young infants, 0-59 days old, with clinically diagnosed severe infections, or with fast breathing, 4 trials of simplified antibiotic therapy delivered in primary care clinics (Pakistan, Democratic Republic of Congo, Kenya and Nigeria) or at home (Bangladesh and Nigeria) are being conducted. METHODS: This article describes the scientific rationale for these trials, which share major elements of trial design. All the trials are in settings of high neonatal mortality, where hospitalization is not feasible or frequently refused. All use procaine penicillin and gentamicin intramuscular injections for 7 days as reference therapy and compare this to various experimental arms utilizing comparatively simpler combination regimens with fewer injections and oral amoxicillin. CONCLUSION: The results of these trials will inform World Health Organization policy regarding community case management of young infants with clinical severe infections or with fast breathing.

Nutritional status of orphaned and separated children and adolescents living in community and institutional environments in uasin gishu county, kenya.

OBJECTIVE: To describe the nutritional status of orphaned and separated children and adolescents (OSCA) living in households in the community (HH), on the street, and those in institutional environments in western Kenya. METHODS: The study enrolled OSCA from 300 randomly selected households (HH), 19 Charitable Children's Institutions (CCIs), and 100 street-involved children. Measures of malnutrition were standardized with Z-scores using World Health Organization criteria; Z-scores ≤-2 standard deviations (sd) were moderate-severe malnutrition. Data were analyzed using multivariable logistic regression adjusting for child age, sex, HIV status, whether the child had been hospitalized in the previous year, time living with current guardian, and intra-household clustering for adequacy of diet and moderate-severe malnutrition. RESULTS: Included are data from 2862 participants (1337 in CCI's, 1425 in HH's, and 100 street youth). The population was 46% female with median age at enrolment of 11.1 years. Only 4.4% of households and institutions reported household food security; 93% of children in HH reported an adequate diet vs. 95% in CCI's and 99% among street youth. After adjustment, OSCA in HH were less likely to have an adequate diet compared to those in CCI's (AOR 0.4, 95% CI 0.2-1.0). After adjustment, there were no differences between the categories of children on weight-for-age, weight-for-height, or BMI-for-age. Children living in HH (AOR 2.6, 95% CI: 2.0-3.4) and street youth (AOR: 5.9, 95% CI: 3.6-9.5) were more likely than children in CCI's to be low height-for-age. CONCLUSION: OSCA in HH are less likely to have an adequate diet compared to children in CCI's. They and street children are more likely to be moderately-severely low height-for-age compared to children in CCI's, suggesting chronic malnutrition among them.

Disclosure of HIV status to children in resource-limited settings: a systematic review.

INTRODUCTION: Informing children of their own HIV status is an important aspect of long-term disease management, yet there is little evidence of how and when this type of disclosure takes place in resource-limited settings and its impact. METHODS: MEDLINE, EMBASE and Cochrane Databases were searched for the terms hiv AND disclos* AND (child* OR adolesc*). We reviewed 934 article citations and the references of relevant articles to find articles describing disclosure to children and adolescents in resource-limited settings. Data were extracted regarding prevalence of disclosure, factors influencing disclosure, process of disclosure and impact of disclosure on children and caregivers. RESULTS: Thirty-two articles met the inclusion criteria, with 16 reporting prevalence of disclosure. Of these 16 studies, proportions of disclosed children ranged from 0 to 69.2%. Important factors influencing disclosure included the child's age and perceived ability to understand the meaning of HIV infection and factors related to caregivers, such as education level, openness about their own HIV status and beliefs about children's capacities. Common barriers to disclosure were fear that the child would disclose HIV status to others, fear of stigma and concerns for children's emotional or physical health. Disclosure was mostly led by caregivers and conceptualized as a one-time event, while others described it as a gradual process. Few studies measured the impact of disclosure on children. Findings suggested adherence to antiretroviral therapy (ART) improved post-disclosure but the emotional and psychological effects of disclosure were variable. CONCLUSIONS: Most studies show that a minority of HIV-infected children in resource-limited settings know his/her HIV status. While caregivers identify many factors that influence disclosure, studies suggest both positive and negative effects for children. More research is needed to implement age- and culture-appropriate disclosure in resource-limited settings.

Harnessing the power of the grassroots to conduct public health research in sub-Saharan Africa: a case study from western Kenya in the adaptation of community-based participatory research (CBPR) approaches.

BACKGROUND: Community-based participatory research (CBPR) is a collaborative approach to research that involves the equitable participation of those affected by an issue. As the field of global public health grows, the potential of CBPR to build capacity and to engage communities in identification of problems and development and implementation of solutions in sub-Saharan Africa has yet to be fully tapped. The Orphaned and Separated Children's Assessments Related to their Health and Well-Being (OSCAR) project is a longitudinal cohort of orphaned and non-orphaned children in Kenya. This paper will describe how CBPR approaches and principles can be incorporated and adapted into the study design and methods of a longitudinal epidemiological study in sub-Saharan Africa using this project as an example. METHODS: The CBPR framework we used involves problem identification, feasibility and planning; implementation; and evaluation and dissemination. This case study will describe how we have engaged the community and adapted CBPR methods to OSCAR's Health and Well-being Project's corresponding to this framework in four phases: 1) community engagement, 2) sampling and recruitment, 3) retention, validation, and follow-up, and 4) analysis, interpretation and dissemination. RESULTS: To date the study has enrolled 3130 orphaned and separated children, including children living in institutional environments, those living in extended family or other households in the community, and street-involved children and youth. Community engagement and participation was integral in refining the study design and identifying research questions that were impacting the community. Through the participation of village Chiefs and elders we were able to successfully identify eligible households and randomize the selection of participants. The on-going contribution of the community in the research process has been vital to participant retention and data validation while ensuring cultural and community relevance and equity in the research agenda. CONCLUSION: CBPR methods have the ability to enable and strengthen epidemiological and public health research in sub-Saharan Africa within the social, political, economic and cultural contexts of the diverse communities on the continent. This project demonstrates that adaptation of these methods is crucial to the successful implementation of a community-based project involving a highly vulnerable population.

Community perspectives on research consent involving vulnerable children in Western Kenya.

Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent.

A qualitative study using traditional community assemblies to investigate community perspectives on informed consent and research participation in western Kenya.

BACKGROUND: International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings. METHODS: We sought to use mabaraza, traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts. RESULTS: Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent. CONCLUSIONS: Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research.