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IntroductionFeeding infants a sub-optimal diet deprives them of critical nutrients for their physical and cognitive development. The objective of this study is to describe the intake of foods of low nutritional value (junk foods) and identify the association with growth and developmental outcomes in infants up to 18 months in low-resource settings.MethodsThis is a secondary analysis of data from an iron-rich complementary foods (meat versus fortified cereal) randomized clinical trial on nutrition conducted in low-resource settings in four low- and middle-income countries (Democratic Republic of the Congo, Guatemala, Pakistan, and Zambia). Mothers in both study arms received nutritional messages on the importance of exclusive breastfeeding up to 6 months with continued breastfeeding up to at least 12 months. This study was designed to identify the socio-demographic predictors of feeding infants’ complementary foods of low nutritional value (junk foods) and to assess the associations between prevalence of junk food use with neurodevelopment (assessed with the Bayley Scales of Infant Development II) and growth at 18 months.Results1,231 infants were enrolled, and 1,062 (86%) completed the study. Junk food feeding was more common in Guatemala, Pakistan, and Zambia than in the Democratic Republic of Congo. 7% of the infants were fed junk foods at 6 months which increased to 70% at 12 months. Non-exclusive breastfeeding at 6 months, higher maternal body mass index, more years of maternal and paternal education, and higher socioeconomic status were associated with feeding junk food. Prevalence of junk foods use was not associated with adverse neurodevelopmental or growth outcomes.ConclusionThe frequency of consumption of junk food was high in these low-resource settings but was not associated with adverse neurodevelopment or growth over the study period.

Abstract Background Nearly half the world’s babies are born at home. We sought to evaluate the training, knowledge, skills, and access to medical equipment and testing for home birth attendants across 7 international sites. Methods Face-to-face interviews were done by trained interviewers to assess level of training, knowledge and practices regarding care during the antenatal, intrapartum and postpartum periods. The survey was administered to a sample of birth attendants conducting home or out-of-facility deliveries in 7 sites in 6 countries (India, Pakistan, Guatemala, Democratic Republic of the Congo, Kenya and Zambia). Results A total of 1226 home birth attendants were surveyed. Less than half the birth attendants were literate. Eighty percent had one month or less of formal training. Most home birth attendants did not have basic equipment (e.g., blood pressure apparatus, stethoscope, infant bag and mask manual resuscitator). Reporting of births and maternal and neonatal deaths to government agencies was low. Indian auxilliary nurse midwives, who perform some home but mainly clinic births, were far better trained and differed in many characteristics from the birth attendants who only performed deliveries at home. Conclusions Home birth attendants in low-income countries were often illiterate, could not read numbers and had little formal training. Most had few of the skills or access to tests, medications and equipment that are necessary to reduce maternal, fetal or neonatal mortality.

Abstract This research describes the proportion of children in four low‐ and middle‐income countries with adequate dietary practices at 6, 12, 18 and 24 months of age and how these practices changed over time using the World Health Organisation and UNICEF's infant young child feeding (IYCF) indicators. The associations between the IYCF indicators and anthropometric z‐scores from 6 to 24 months, and between the IYCF indicators and the family care indicators (FCIs) at 24 months are described. This was a longitudinal study of offspring from participants in the Women First Preconception Maternal Nutrition Trial conducted in Sud‐Ubangi, Democratic Republic of Congo; Chimaltenango, Guatemala; Belagavi, North Karnataka, India; and Thatta, Sindh Province, Pakistan. The frequency of the minimum dietary diversity (MDD), minimum meal frequency (MMF), and minimum adequate diet (MAD) increased between 6 and 24 months, but even at 24 months MAD remained below 50% at all sites. MDD (β = 0.12; 95% CI = 0.04−0.22) and MMF (β = 0.10; 95% CI = 0.03−0.17) were positively associated with length‐for‐age z‐score at 24 months. All IYCF indicators were positively associated with mean total FCI score: MDD (proportion ratio [PR] = 1.04; 95% CI = 1.02−1.07), MMF (PR = 1.02; 95% CI = 1.01−1.04), MAD (PR = 1.05; 95% CI = 1.02−1.08). Although there are multiple barriers to young children having an adequate diet, our results support a positive association between familial interactions and improved IYCF feeding practices.

IntroductionAdolescent (35 years) pregnancies carry adverse risks and warrant a critical review in low- and middle-income countries where the burden of adverse pregnancy outcomes is highest.ObjectiveTo describe the prevalence and adverse pregnancy (maternal, perinatal, and neonatal) outcomes associated with extremes of maternal age across six countries.Patients and methodsWe performed a historical cohort analysis on prospectively collected data from a population-based cohort study conducted in the Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan, and Zambia between 2010 and 2020. We included pregnant women and their neonates. We describe the prevalence and adverse pregnancy outcomes associated with pregnancies in these maternal age groups (35 years). Relative risks and 95% confidence intervals of each adverse pregnancy outcome comparing each maternal age group to the reference group of 20–24 years were obtained by fitting a Poisson model adjusting for site, maternal age, parity, multiple gestations, maternal education, antenatal care, and delivery location. Analysis by region was also performed.ResultsWe analyzed 602,884 deliveries; 13% (78,584) were adolescents, and 5% (28,677) were advanced maternal age (AMA). The overall maternal mortality ratio (MMR) was 147 deaths per 100,000 live births and increased with advancing maternal age: 83 in the adolescent and 298 in the AMA group. The AMA groups had the highest MMR in all regions. Adolescent pregnancy was associated with an adjusted relative risk (aRR) of 1.07 (1.02–1.11) for perinatal mortality and 1.13 (1.06–1.19) for neonatal mortality. In contrast, AMA was associated with an aRR of 2.55 (1.81 to 3.59) for maternal mortality, 1.58 (1.49–1.67) for perinatal mortality, and 1.30 (1.20–1.41) for neonatal mortality, compared to pregnancy in women 20–24 years. This pattern was overall similar in all regions, even in the

Objectives We examined gestational age (GA) estimates for live and still births, and prematurity rates based on last menstrual period (LMP) compared with ultrasonography (USG) among pregnant women at seven sites in six low-resource countries.Design Prospective cohort studySetting and participants This study included data from the Global Network’s population-based Maternal and Newborn Health Registry which follows pregnant women in six low-income and middle-income countries (Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan and Zambia). Participants in this analysis were 42 803 women, including their 43 230 babies, who registered for the study in their first trimester based on GA estimated either by LMP or USG and had a live or stillbirth with an estimated GA of 20–42 weeks.Outcome measures GA was estimated in weeks and days based on LMP and/or USG. Prematurity was defined as GA of 20 weeks+0 days through 36 weeks+6 days, calculated by both USG and LMP.Results Overall, average GA varied ≤1 week between LMP and USG. Mean GA for live births by LMP was lower than by USG (adjusted mean difference (95% CI) = −0.23 (–0.29 to –0.17) weeks). Among stillbirths, a higher GA was estimated by LMP than USG (adjusted mean difference (95% CI)= 0.42 (0.11 to 0.72) weeks). Preterm birth rates for live births were significantly higher when dated by LMP (adjusted rate difference (95% CI)= 4.20 (3.56 to 4.85)). There was no significant difference in preterm birth rates for stillbirths.Conclusion The small differences in GA for LMP versus USG in the Guatemalan and Indian sites suggest that LMP may be a useful alternative to USG for GA dating during the first trimester until availability of USG improves in those areas. Further research is needed to assess LMP for first-trimester GA dating in other regions with limited access to USG.Trial registration number NCT01073475.

Introduction Maternal and neonatal infections are among the most frequent causes of maternal and neonatal mortality, and current antibiotic strategies have been ineffective in preventing many of these deaths. A randomised clinical trial conducted in a single site in The Gambia showed that treatment with an oral dose of 2 g azithromycin versus placebo for all women in labour reduced certain maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. In a large, multinational randomised trial, we will evaluate the impact of azithromycin given in labour to improve maternal and newborn outcomes.Methods and analysis This randomised, placebo-controlled, multicentre clinical trial includes two primary hypotheses, one maternal and one neonatal. The maternal hypothesis is to test whether a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labour will reduce maternal death or sepsis. The neonatal hypothesis will test whether this intervention will reduce intrapartum/neonatal death or sepsis. The intervention is a single, prophylactic intrapartum oral dose of 2 g azithromycin, compared with a single intrapartum oral dose of an identical appearing placebo. A total of 34 000 labouring women from 8 research sites in sub-Saharan Africa, South Asia and Latin America will be randomised with a one-to-one ratio to intervention/placebo. In addition, we will assess antimicrobial resistance in a sample of women and their newborns.Ethics and dissemination The study protocol has been reviewed and ethics approval obtained from all the relevant ethical review boards at each research site. The results will be disseminated via peer-reviewed journals and national and international scientific forums.Trial registration number NCT03871491 (https://clinicaltrials.gov/ct2/show/NCT03871491?term=NCT03871491&draw=2&rank=1).

Résumé Dans un régime démocratique, le peuple est considéré comme la source du pouvoir en ce sens qu’il est détenteur de la souveraineté conformément à la constitution1 , qu’il exerce directement ou indirectement par la voie des urnes en élisant ses représentants. Les élections demeurent un mode d’expression ou de désignation par excellence pour un peuple dans le choix d’un nouveau gouvernement.2 Il apparait clairement que l’élection constitue l’essence de la démocratie. Cependant, en Afrique et partout ailleurs, la réalité des urnes fait l’objet des différentes contestations entre les acteurs politiques ; celles-ci peuvent conduire à des troubles post électoraux3mettant ainsi en péril la paix et la sécurité sociale. Les contestations tournent tantôt autour de la fiabilité du processus électoral, tantôt autour de l’acceptation des résultats des élections ou encore sur les irrégularités et les fraudes qui auraient entaché le processus électoral. Les différents acteurs empruntent généralement la voie de droit qui consiste à se référer au juge électoral pour connaitre de la contestation. Il ya lieu de considéré qu’en démocratie, le contentieux électoral apparait comme la technique la mieux indiquée pour assurer autant que possible l’équité et la présentation démocratique. Il est avancé qu’il n’y a pas de véritable élection démocratique et crédible sans contentieux4 . Comme nous pouvons le souligner, le contentieux électoral est un contentieux de sincérité5 qui permet de crédibiliser et légitimer les pouvoirs des gouvernants. En RDC comme ailleurs, l’effectivité démocratique dépend non seulement de son contenu et de son esprit mais aussi, c’est presque une évidence de l’affirmer, du respect que doivent lui porter les électeurs, les candidats mais aussi les juges et les autorités politiques. C’est à ce prix que les élections, comme le soutient jean du bois de Gaudusson, deviennent le temps de la démocratie et du maintien de la paix.6 Lorsqu’ on jette un regard critique sur l’examen minutieux par la cour constitutionnelle congolaise, il se constate qu’au lieu de régler les litiges, la cour constitutionnelle a, généralement, créé ou été à la base de la survenance d’autres contentieux en violations flagrantes de la loi. Mots-clés : protection, droit à l’éligibilité, contentieux électoral, congolais, élections Abstract In a democratic regime, the people are considered the source of power in the sense that they hold sovereignty in accordance with the constitution, which they exercise directly or indirectly through the ballot box by electing their representatives. Elections remain a mode of expression or designation par excellence for a people in the choice of a new government. It is clear that election is the essence of democracy. However, in Africa and everywhere else, the reality of the ballot box is the subject of various disputes between political actors; these can lead to post-electoral unrest, thus jeopardizing peace and social security. The disputes revolve sometimes around the reliability of the electoral process, sometimes around the acceptance of the results of the elections or even on the irregularities and the frauds which would have tainted the electoral process. The various actors generally take the legal route, which consists of referring to the electoral judge to hear about the dispute. It should be considered that in a democracy, electoral disputes appear to be the best technique to ensure fairness and democratic representation as much as possible. It is argued that there is no real democratic and credible election without litigation. As we can underline, electoral litigation is a litigation of sincerity which makes it possible to give credibility and legitimize the powers of those who govern. In the DRC as elsewhere, democratic effectiveness depends not only on its content and its spirit but also, it is almost obvious to affirm it, on the respect that voters, candidates, but also judges and political authorities. It is at this price that elections, as Jean du Bois de Gaudusson argues, become the time for democracy and peacekeeping. When one takes a critical look at the scrutiny by the Congolese constitutional court, it is found that instead of settling disputes, the constitutional court has generally created or been the basis for the occurrence of other disputes. in flagrant violations of the law.

Résumé Dans le contexte des droits de l’homme, il sied d’indiquer que le déficit de leur appropriation est à la base des écarts entre les textes et la pratique qu’on en fait. Ces droits, remarquables soient-ils, resteront improductifs tant que le compromis qu’exige l’Etat de droit substantiel ne sera pas trouvé. En réalité, on assiste à une quasi contrariété entre ce que prévoient les corpus des règles et ce qui résulte des Comportements concrets voire des rapports sociaux. D’après Sylvia Calmes, la qualité d’un ordre juridique est tributaire de sa capacité d’assurer aux citoyennes lisibilités et confiance dans ce qui constitue le droit en un moment donné et ce qui, selon toute probabilité, sera le droit dans l’avenir (1). Ainsi, le droit crée, pour les citoyens, un cadre clair, précis, stable leur apportant les éléments de certitude nécessaire et leur donnant la possibilité d’en cerner réellement le contenu, la portée, la raison d’être et les limites. Le droit ne doit pas se limiter au « tas » de textes. Un des traits marquants de son ancrage et de son intériorisation est l’existence d’une législation connue de tous et applicable par tous ; une législation non secrète mais publique de telle sorte que les citoyens puissent en avoir normalement connaissance (2). Même si à son article 62, alinéa 1er, la Constitution du 18 février 2006 impose la connaissance de la loi à tout citoyen, il faut, à notre avis, un effort supplémentaire, celui d’une prise en main du droit par ses destinataires. Ce qui va permettre, à coup sûr, d’influer sensiblement sur l’usage qu’on en fait. Cette étude a l’avantage de plaider pour la recherche de l’adéquation entre le texte et le contexte de son application (3). Abstract In the context of human rights, it is important to point out that the lack of ownership of human rights is at the root of the gaps between the texts and their practice. These rights, however remarkable, will remain unproductive as long as the compromise required by the substantive rule of law is not found. In reality, we are witnessing a quasicontradiction between what the corpus of rules provides for and what results from concrete behaviors or even social relationships. According to Sylvia Calmes, the quality of a legal order depends on its capacity to assure to the citizens legibility and confidence in what constitutes the law in a given moment and what, in all probability, will be the law in the future. Thus, the law creates, for the citizens, a clear, precise, stable framework bringing them the necessary elements of certainty and giving them the possibility to really identify the content, the scope, the raison d'être and the limits. The law must not be limited to the "pile" of texts. One of the outstanding features of its anchoring and internalization is the existence of a legislation known by all and applicable by all; a legislation that is not secret but public so that the citizens can normally have knowledge of it. Even if in its article 62, paragraph 1, the Constitution of 18 February 2006 imposes the knowledge of the law to every citizen, it is necessary, in our opinion, an additional effort, that of a taking in hand of the law by its recipients. This will undoubtedly have a significant impact on the way the law is used. This study has the advantage of arguing for the search for adequacy between the text and the context of its application.

Aim: To evaluate the impact of heart rate-guided basic resuscitation compared to Helping Babies Breathe on neonatal outcomes and resuscitation practices in the Democratic Republic of the Congo. Methods: We conducted a pre-post clinical trial comparing heart rate-guided basic resuscitation to Helping Babies Breathe in three facilities, enrolling in-born neonates ≥28 weeks gestation. We collected observational data during a convenience sample of resuscitations and extracted clinical data from the medical record for all participants. We evaluated our primary outcome of effective breathing at three minutes after birth among newborns not breathing well at 30 seconds after birth employing generalized linear models using maximum likelihood estimation. Results: Among 1,284 newborns with observational data, there was no difference in the proportion effectively breathing at three minutes (adjusted relative risk 1.08 [95% CI 0.81, 1.45]). Among 145 receiving bag mask ventilation, time to bag mask ventilation decreased 64.3 seconds during heart rate-guided resuscitation (p<0.001). Among 10,906 enrolled in the trial, perinatal mortality was unchanged (adjusted relative risk 1.19 [95% CI 0.96, 1.48]) and death before discharge increased (adjusted relative risk 1.43 [95% CI 1.03, 1.99]). Expert review of stillborn cases demonstrated a stillbirth misclassification rate of 33.3% during Helping Babies Breathe versus 5.9% in heart rate-guided resuscitation. Conclusion: During heart rate-guided basic resuscitation, time to bag mask ventilation was reduced by greater than one minute. The increase in death before discharge and unchanged perinatal mortality may be due to resuscitation of newborns with a higher risk of mortality who were previously presumed stillborn. A cluster-randomized trial of heart rate-guided basic resuscitation is needed to evaluate its impact on neonatal mortality in low-resource settings. [ABSTRACT FROM AUTHOR]

Objective: To describe the intrapartum and postpartum use of non‐study antibiotics in low‐ and middle‐income countries (LMICs) during the double‐blinded NICHD Global Network Azithromycin in Labor (A‐PLUS) trial. Design: The antibiotic use sub‐study was a planned prospective, observational sub‐study of the A‐PLUS trial. Settings: The study was carried out in hospitals or health centres affiliated with eight sites of the Global Network for Women's and Children's Health Research (Global Network) in seven countries: Bangladesh, Pakistan, India (two sites), Kenya, Zambia, The Democratic Republic of the Congo (DRC) and Guatemala. Population: Totally, 29 278 pregnant women enrolled in the A‐PLUS trial. Methods: We collected data on 29 278 pregnant women admitted to a facility for delivery related to non‐study antibiotic use overall and during three time periods: (1) in the facility prior to delivery, (2) after delivery until facility discharge and (3) after discharge to 42 days post‐partum. Main Outcome Measures: Non‐study antibiotic use overall and for treatment or prophylaxis by the site during the three time periods. Results: Of the 29 278 women in the study, 5020 (17.1%; 95% CI 16.7%–17.6%) received non‐study antibiotics in the facility prior to delivery, 11 956 (40.8%; 95% CI 40.3%–41.4%) received non‐study antibiotics in the facility after delivery, and 13 390 (47.6%; 95% CI 47.0%–48.2%) women received non‐study antibiotics after delivery and after facility discharge. Antibiotics were prescribed more often among women in the Asian and Guatemalan sites than in the African sites. In the three time‐periods, among those receiving antibiotics, prophylaxis was the indication in 82.3%, 97.7% and 90.7% of the cases, respectively. The type of antibiotics used varied substantially by time‐period and site, but generally, penicillin‐type drugs, cephalosporin‐type drugs and metronidazole were used more frequently than other types. Conclusions: Across the eight sites of the Global Network, in the facility before delivery, and in the post‐partum periods before and after facility discharge, antibiotics were used frequently, but use was highly variable by site and time‐period. [ABSTRACT FROM AUTHOR]

Background: Few studies have assessed the impact of first-trimester malaria infection during pregnancy. We estimated this impact on adverse maternal and pregnancy outcomes. Methods: In a convenience sample of women from the ASPIRIN (Aspirin Supplementation for Pregnancy Indicated risk Reduction In Nulliparas) trial in Kenya, Zambia, and the Democratic Republic of the Congo, we tested for first-trimester Plasmodium falciparum infection using quantitative polymerase chain reaction. We estimated site-specific effects on pregnancy outcomes using parametric g-computation. Results: Compared to uninfected women, we observed the adjusted site-specific prevalence differences (PDs) among women with first-trimester malaria of the following pregnancy outcomes: preterm birth among Congolese (aPD = 0.06 [99% CI: -0.04, 0.16]), Kenyan (0.03 [-0.04, 0.09]), and Zambian (0.00 [-0.10, 0.20]) women; low birth weight among Congolese (0.07 [-0.03, 0.16]), Kenyan (0.01 [-0.04, 0.06]) and Zambian (-0.04 [-0.13, 0.16]) women; spontaneous abortion among Congolese (0.00 [-0.05, 0.04]), Kenyan (0.00 [-0.04, 0.04]), and Zambian (0.02 [-0.07, 0.24]) women, and anemia later in pregnancy among Congolese (0.04 [-0.09, 0.16]), Kenyan (0.05 [-0.06, 0.17]), and Zambian (0.07 [-0.12, 0.36]) women. The pooled PD for anemia later in pregnancy (26–30 weeks) was 0.08 [99% CI: 0.00, 0.16]. Conclusions: First-trimester malaria was associated with increased prevalence of anemia later in pregnancy. We identified areas for further investigation including effects of first-trimester malaria on preterm birth and low birth weight. [ABSTRACT FROM AUTHOR]

Background900,000 newborns die from respiratory depression each year; nearly all of these deaths occur in low- and middle-income countries. Deaths from respiratory depression are reduced by evidence-based resuscitation. Electronic heart rate monitoring provides a sensitive indicator of the neonate's status to inform resuscitation care, but is infrequently used in low-resource settings. In a recent trial in the Democratic Republic of the Congo, midwives used a low-cost, battery-operated heart rate meter (NeoBeat) to continuously monitor heart rate during resuscitations. We explored midwives' perceptions of NeoBeat including its utility and barriers and facilitators to use.MethodsAfter a 20-month intervention in which midwives from three facilities used NeoBeat during resuscitations, we surveyed midwives and conducted focus group discussions (FGDs) regarding the incorporation of NeoBeat into clinical care. FGDs were conducted in Lingala, the native language, then transcribed and translated from Lingala to French to English. We analyzed data by: (1) coding of transcripts using Nvivo, (2) comparison of codes to identify patterns in the data, and (3) grouping of codes into categories by two independent reviewers, with final categories determined by consensus.ResultsEach midwife from Facility A used NeoBeat on an estimated 373 newborns, while each midwife at facilities B and C used NeoBeat an average 24 and 47 times, respectively. From FGDs with 30 midwives, we identified five main categories of perceptions and experiences regarding the use of NeoBeat: (1) Providers' initial skepticism evolved into pride and a belief that NeoBeat was essential to resuscitation care, (2) Providers viewed NeoBeat as enabling their resuscitation and increasing their capacity, (3) NeoBeat helped providers identify flaccid newborns as liveborn, leading to hope and the perception of saving of lives, (4) Challenges of use of NeoBeat included cleaning, charging, and insufficient quantity of devices, and (5) Providers desired to continue using the device and to expand its use beyond resuscitation and their own facilities.ConclusionMidwives perceived that NeoBeat enabled their resuscitation practices, including assisting them in identifying non-breathing newborns as liveborn. Increasing the quantity of devices per facility and developing systems to facilitate cleaning and charging may be critical for scale-up.

Multiple factors influence infant and child neurodevelopment in low resource settings. In offspring of participants in the preconception maternal nutrition trial, Women First (WF), we examined the impact of providing a preconception (Arm 1) or prenatal (Arm 2) nutrient supplement (compared to controls, Arm 3) on neurodevelopmental outcomes at 24 months; predictors of neurodevelopment scores; and associations of infant anthropometrics with neurodevelopmental scores. Follow‐up visits for anthropometry were conducted at 6‐, 12‐, 18‐ and 24‐month of age. At 24‐months, in a randomized subset, the Bayley Scales of Infant Development, 3rd edition (BSID‐III), including cognitive, motor and social‐emotional subscales, and the Family Care Indicators (FCI) questionnaire, assessing family and home environment, were completed. Multiple covariates (intervention arm, site, maternal sociodemographic characteristics, FCI subscales, birthweight and 6–24 months' change in anthropometry z‐scores, (e.g., ΔLAZ6–24) were evaluated by linear regression to predict BSID‐III outcomes and to assess associations of anthropometric changes with BSID‐III scores. The analysis consisted of 1386 infants (n = 441, 486, 459 for Arms 1, 2 and 3, respectively). None of the domain‐specific BSID‐III subscale scores differed by maternal intervention arm. Four covariates significantly predicted (p ≤ 0.01) all 3 BSID‐III subscales: secondary maternal education, ΔLAZ6–24, birthweight >2500 g, and FCI play materials. Linear growth was associated with all domains of neurodevelopment. The results underscore the multi‐dimensional aspects of child development represented by the nurturing care framework, including prenatal maternal nutrition, post‐natal growth, maternal education for responsive caregiving and opportunities for early learning. Key messages: Preconception and prenatal maternal nutrition is important to ensure adequate fetal growth and healthy birthweight.Preconception and prenatal maternal nutritional supplementation was not associated with young child neurodevelopment but has been shown to improve post‐natal growth.Post‐natal linear growth is consistently associated with offspring neurodevelopment at 24 months.Maternal education to foster responsive caregiving, and opportunities for early learning in the home also positively impact offspring neurodevelopmental outcomes.These findings underscore the importance of multi‐dimensional aspects essential for children to reach their full developmental potential. [ABSTRACT FROM AUTHOR]

Objectives: Antibiotic use is increasing in low- and middle-income countries (LMIC); however, few studies have examined the rates of use in a population. The use of antibiotics for liveborn infants in LMIC was examined. Design: The study, a planned prospective, observational secondary analysis of the A-PLUS randomised controlled trial of azithromycin, was conducted in Global Network sites in seven countries: Bangladesh, Pakistan, India (two sites), Kenya, Zambia, the Democratic Republic of Congo and Guatemala. The analyses included liveborn infants of women planning a vaginal delivery who were enrolled in the A-PLUS trial. Methods: Data were collected on liveborn infants related to non-study antibiotic use in two time-periods: (i) after delivery while in the facility, and (ii) after discharge until 42 days post-partum. Antibiotic use was also examined in preterm and term infants. The most commonly used antibiotics were classified into three groups: penicillins, cephalosporins and aminoglycosides. Antibiotics used in <1% of infants are not presented. Results: Of the 29,354 eligible infants in the study, 2224 (7.6%, 95% CI 7.3–7.9) received non-study antibiotics in the facility after delivery, and 3847 (13.1%, 95% CI 12.7–13.5) received non-study antibiotics after facility discharge until Day 42. In the facility, antibiotics were given to newborns more frequently in sites in Asia and less frequently in sites in Africa and Guatemala. Similarly, after facility discharge, infants were more likely to receive antibiotics in the Asian sites and less so in the African sites and Guatemala. In the facilities, antibiotics were used predominately for prophylaxis (70.7%) but after facility discharge antibiotics were given more often for treatment (56.8%). Preterm infants received more non-study antibiotics than term infants. The antibiotics used varied substantially by time-period and site but, in general, penicillins, cephalosporins and aminoglycosides were the antibiotic categories used more frequently. Conclusions: Across the Global Network sites, which represent a range of LMIC, nearly 8% of infants received non-study antibiotics more often for prophylaxis, with 13% of infants receiving non-study antibiotics following hospital discharge. With concerns about increasing antimicrobial resistance worldwide, further attention should be given to appropriate antibiotic use. [ABSTRACT FROM AUTHOR]

ObjectiveTo characterize the changes in gut microbiota during pregnancy and determine the effects of nutritional intervention on gut microbiota in women from sub-Saharan Africa (the Democratic Republic of the Congo, DRC), South Asia (India and Pakistan), and Central America (Guatemala).MethodsPregnant women in the Women First (WF) Preconception Maternal Nutrition Trial were included in this analysis. Participants were randomized to receive a lipid-based micronutrient supplement either ≥3 months before pregnancy (Arm 1); started the same intervention late in the first trimester (Arm 2); or received no nutrition supplements besides those self-administered or prescribed through local health services (Arm 3). Stool and blood samples were collected during the first and third trimesters. Findings presented here include fecal 16S rRNA gene-based profiling and systemic and intestinal inflammatory biomarkers, including alpha (1)-acid glycoprotein (AGP), C-reactive protein (CRP), fecal myeloperoxidase (MPO), and calprotectin.ResultsStool samples were collected from 640 women (DRC, n = 157; India, n = 102; Guatemala, n = 276; and Pakistan, n = 105). Gut microbial community structure did not differ by intervention arm but changed significantly during pregnancy. Richness, a measure of alpha-diversity, decreased over pregnancy. Community composition (beta-diversity) also showed a significant change from first to third trimester in all four sites. Of the top 10 most abundant genera, unclassified Lachnospiraceae significantly decreased in Guatemala and unclassified Ruminococcaceae significantly decreased in Guatemala and DRC. The change in the overall community structure at the genus level was associated with a decrease in the abundances of certain genera with low heterogeneity among the four sites. Intervention arms were not significantly associated with inflammatory biomarkers at 12 or 34 weeks. AGP significantly decreased from 12 to 34 weeks of pregnancy, whereas CRP, MPO, and calprotectin did not significantly change over time. None of these biomarkers were significantly associated with the gut microbiota diversity.ConclusionThe longitudinal reduction of individual genera (both commensals and potential pathogens) and alpha-diversity among all sites were consistent and suggested that the effect of pregnancy on the maternal microbiota overrides other influencing factors, such as nutrition intervention, geographical location, diet, race, and other demographical variables.

Abstract Background Nulliparity has been associated with lower birth weight (BW) and other adverse pregnancy outcomes, with most of the data coming from high-income countries. In this study, we examined birth weight for gestational age z-scores and neonatal (28-day) mortality in a large prospective cohort of women dated by first trimester ultrasound from multiple sites in low and middle-income countries. Methods Pregnant women were recruited during the first trimester of pregnancy and followed through 6 weeks postpartum from Maternal Newborn Health Registry (MNHR) sites in the Democratic Republic of Congo (DRC), Guatemala, Belagavi and Nagpur, India, and Pakistan from 2017 and 2018. Data related to the pregnancy and its outcomes were collected prospectively. First trimester ultrasound was used for determination of gestational age; (BW) was obtained in grams within 48 h of delivery and later transformed to weight for age z-scores (WAZ) adjusted for gestational age using the INTERGROWTH-21st standards. Results 15,121 women were eligible and included. Infants of nulliparous women had lower mean BWs (males: 2676 gr, females: 2587 gr, total: 2634 gr) and gestational age adjusted weight for age z-scores (males: − 0.73, females: − 0.77, total: − 0.75,) than women with one or more previous pregnancies. The largest differences were between zero and one previous pregnancies among female infants. The associations of parity with BW and z-scores remained even after adjustment for maternal age, maternal height, maternal education, antenatal care visits, hypertensive disorders, and socioeconomic status. Nulliparous women also had a significantly higher

Abstract Background Birth weight (BW) is a strong predictor of neonatal outcomes. The purpose of this study was to compare BWs between global regions (south Asia, sub-Saharan Africa, Central America) prospectively and to determine if trends exist in BW over time using the population-based maternal and newborn registry (MNHR) of the Global Network for Women'sand Children's Health Research (Global Network). Methods The MNHR is a prospective observational population-based registryof six research sites participating in the Global Network (2013–2018), within five low- and middle-income countries (Kenya, Zambia, India, Pakistan, and Guatemala) in threeglobal regions (sub-Saharan Af rica, south Asia, Central America). The birth weights were obtained for all infants born during the study period. This was done either by abstracting from the infants' health facility records or from direct measurement by the registry staff for infants born at home. After controlling for demographic characteristics, mixed-effect regression models were utilized to examine regional differences in birth weights over time. Results The overall BW meanswere higher for the African sites (Zambia and Kenya), 3186 g (SD 463 g) in 2013 and 3149 g (SD 449 g) in 2018, ascompared to Asian sites (Belagavi and Nagpur, India and Pakistan), 2717 g (SD450 g) in 2013 and 2713 g (SD 452 g) in 2018. The Central American site (Guatemala) had a mean BW intermediate between the African and south Asian sites, 2928 g (SD 452) in 2013, and 2874 g (SD 448) in 2018. The low birth weight (LBW) incidence was highest in the south Asian sites (India and Pakistan) and lowest in the African sites (Kenya and Zambia). The size of regional differences varied somewhat over time with slight decreases in the gap in birth weights between the African and Asian sites and slight increases in the gap between the African and Central American sites. Conclusions Overall, BWmeans by global region did not change significantly over the 5-year study period. From 2013 to 2018, infants enrolled at the African sites demonstrated the highest BW means overall across the entire study period, particularly as compared to Asian sites. The incidence of LBW was highest in the Asian sites (India and Pakistan) compared to the African and Central American sites. Trial registration The study is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475.

Abstract Background Due to high fertility rates in some low and lower-middle income countries, the interval between pregnancies can be short, which may lead to adverse maternal and neonatal outcomes. Methods We analyzed data from women enrolled in the NICHD Global Network Maternal Newborn Health Registry (MNHR) from 2013 through 2018. We report maternal characteristics and outcomes in relationship to the inter-delivery interval (IDI, time from previous delivery [live or stillborn] to the delivery of the index birth), by category of 6–17 months (short), 18–36 months (reference), 37–60 months, and 61–180 months (long). We used non-parametric tests for maternal characteristics, and multivariable logistic regression models for outcomes, controlling for differences in baseline characteristics. Results We evaluated 181,782 women from sites in the Democratic Republic of Congo, Zambia, Kenya, Guatemala, India, and Pakistan. Women with short IDI varied by site, from 3% in the Zambia site to 20% in the Pakistan site. Relative to a 18–36 month IDI, women with short IDI had increased risk of neonatal death (RR = 1.89 [1.74, 2.05]), stillbirth (RR = 1.70 [1.56, 1.86]), low birth weight (RR = 1.38 [1.32, 1.44]), and very low birth weight (RR = 2.35 [2.10, 2.62]). Relative to a 18–36 month IDI, women with IDI of 37–60 months had an increased risk of maternal death (RR 1.40 [1.05, 1.88]), stillbirth (RR 1.14 [1.08, 1.22]), and very low birth weight (RR 1.10 [1.01, 1.21]). Relative to a 18–36 month IDI, women with long IDI had increased risk of maternal death (RR 1.54 [1.10, 2.16]), neonatal death (RR = 1.25 [1.14, 1.38]), stillbirth (RR = 1.50 [1.38, 1.62]), low birth weight (RR = 1.22 [1.17, 1.27]), and very low birth weight (RR = 1.47 [1.32,1.64]). Short and long IDIs were also associated with increased risk of obstructed labor, hemorrhage, hypertensive disorders, fetal malposition, infection, hospitalization, preterm delivery, and neonatal hospitalization. Conclusions IDI varies by site. When compared to 18–36 month IDI, women with both short IDI and long IDI had increased risk of adverse maternal and neonatal outcomes. Trial registration The MNHR is registered at NCT01073475 .

Abstract Background Stillbirth rates are high and represent a substantial proportion of the under-5 mortality in low and middle-income countries (LMIC). In LMIC, where nearly 98% of stillbirths worldwide occur, few population-based studies have documented cause of stillbirths or the trends in rate of stillbirth over time. Methods We undertook a prospective, population-based multi-country research study of all pregnant women in defined geographic areas across 7 sites in low-resource settings (Kenya, Zambia, Democratic Republic of Congo, India, Pakistan, and Guatemala). Staff collected demographic and health care characteristics with outcomes obtained at delivery. Cause of stillbirth was assigned by algorithm. Results From 2010 through 2018, 573,148 women were enrolled with delivery data obtained. Of the 552,547 births that reached 500 g or 20 weeks gestation, 15,604 were stillbirths; a rate of 28.2 stillbirths per 1000 births. The stillbirth rates were 19.3 in the Guatemala site, 23.8 in the African sites, and 33.3 in the Asian sites. Specifically, stillbirth rates were highest in the Pakistan site, which also documented a substantial decrease in stillbirth rates over the study period, from 56.0 per 1000 (95% CI 51.0, 61.0) in 2010 to 44.4 per 1000 (95% CI 39.1, 49.7) in 2018. The Nagpur, India site also documented a substantial decrease in stillbirths from 32.5 (95% CI 29.0, 36.1) to 16.9 (95% CI 13.9, 19.9) per 1000 in 2018; however, other sites had only small declines in stillbirth over the same period. Women who were less educated and older as well as those with less access to antenatal care and with vaginal assisted delivery were at increased risk of stillbirth. The major fetal causes of stillbirth were birth asphyxia (44.0% of stillbirths) and infectious causes (22.2%). The maternal conditions that were observed among those with stillbirth were obstructed or prolonged labor, antepartum hemorrhage and maternal infections. Conclusions Over the study period, stillbirth rates have remained relatively high across all sites. With the exceptions of the Pakistan and Nagpur sites, Global Network sites did not observe substantial changes in their stillbirth rates. Women who were less educated and had less access to antenatal and obstetric care remained at the highest burden of stillbirth. Study registration Clinicaltrials.gov (ID# NCT01073475).

Abstract Background The Global Network for Women's and Children’s Health Research (Global Network) conducts clinical trials in resource-limited countries through partnerships among U.S. investigators, international investigators based in in low and middle-income countries (LMICs) and a central data coordinating center. The Global Network’s objectives include evaluating low-cost, sustainable interventions to improve women’s and children’s health in LMICs. Accurate reporting of births, stillbirths, neonatal deaths, maternal mortality, and measures of obstetric and neonatal care is critical to determine strategies for improving pregnancy outcomes. In response to this need, the Global Network developed the Maternal Newborn Health Registry (MNHR), a prospective, population-based registry of pregnant women, fetuses and neonates receiving care in defined catchment areas at the Global Network sites. This publication describes the MNHR, including participating sites, data management and quality and changes over time. Methods Pregnant women who reside in or receive healthcare in select communities are enrolled in the MNHR of the Global Network. For each woman and her offspring, sociodemographic, health care, and the major outcomes through 42-days post-delivery are recorded. Study visits occur at enrollment during pregnancy, at delivery and at 42 days postpartum. Results From 2010 through 2018, the Global Network MNHR sites were located in Guatemala, Belagavi and Nagpur, India, Pakistan, Democratic Republic of Congo, Kenya, and Zambia. During this period at these sites, 579,140 pregnant women were consented and enrolled in the MNHR, nearly 99% of all eligible women. Delivery data were collected for 99% of enrolled women and 42-day follow-up data for 99% of those delivered. In this supplement, the trends over time and assessment of differences across geographic regions are analyzed in a series of 18 manuscripts utilizing the MNHR data. Conclusions Improving maternal, fetal and newborn health in countries with poor outcomes requires an understanding of the characteristics of the population, quality of health care and outcomes. Because the worst pregnancy outcomes typically occur in countries with limited health registration systems and vital records, alternative registration systems may prove to be highly valuable in providing data. The MNHR, an international, multicenter, population-based registry, assesses pregnancy outcomes over time in support of efforts to develop improved perinatal healthcare in resource-limited areas. Trial Registration The Maternal Newborn Health Registry is registered at Clinicaltrials.gov (ID# NCT01073475). Registered February 23, 2019. https://clinicaltrials.gov/ct2/show/NCT01073475

There is a substantial gap in our understanding of resuscitation practices following Helping Babies Breathe (HBB) training. We sought to address this gap through an analysis of observed resuscitations following HBB 2nd edition training in the Democratic Republic of the Congo. This is a secondary analysis of a clinical trial evaluating the effect of resuscitation training and electronic heart rate monitoring on stillbirths. We included in-born, liveborn neonates ≥28 weeks gestation whose resuscitation care was directly observed and documented. For the 2592 births observed, providers dried/stimulated before suctioning in 97% of cases and suctioned before ventilating in 100%. Only 19.7% of newborns not breathing well by 60 s (s) after birth ever received ventilation. Providers initiated ventilation at a median 347 s (>five minutes) after birth; no cases were initiated within the Golden Minute. During 81 resuscitations involving ventilation, stimulation and suction both delayed and interrupted ventilation with a median 132 s spent drying/stimulating and 98 s suctioning. This study demonstrates that HBB-trained providers followed the correct order of resuscitation steps. Providers frequently failed to initiate ventilation. When ventilation was initiated, it was delayed and interrupted by stimulation and suctioning. Innovative strategies targeting early and continuous ventilation are needed to maximize the impact of HBB.

IntroductionNeonates with serious bacterial infections should be treated with injectable antibiotics after hospitalization, which may not be feasible in many low resource settings. In 2015, the World Health Organization (WHO) launched a guideline for the management of young infants (0-59 days old) with possible serious bacterial infection (PSBI) when referral for hospital treatment is not feasible. We evaluated the feasibility of the WHO guideline implementation in the Democratic Republic of the Congo (DRC) to achieve high coverage of PSBI treatment.MethodsFrom April 2016 to March 2017, in a longitudinal, descriptive, mixed methods implementation research study, we implemented WHO PSBI guideline for sick young infants (0-59 dyas of age) in the public health programme setting in five health areas of North and South Ubangi Provinces with an overall population of about 60,000. We conducted policy dialogue with national and sub-national level government planners, decision-makers, academics and other stakeholders. We established a Technical Support Unit to provide implementation support. We built the capacity of health workers and managers and ensured the availability of necessary medicines and commodities. We followed infants with PSBI signs up to 14 days. The research team systematically collected data on adherence to treatment and outcomes.ResultsWe identified 3050 live births and 285 (9.3%) young infants with signs of PSBI in the study area, of whom 256 were treated. Published data have reported 10% PSBI incidence rate in young infants. Therefore, the estimated coverage of treatment was 83.9% (256/305). Another 426 from outside the study catchment area were also identified with PSBI signs by the nurses of a health centre within the study area. Thus, a total of 711 young infants with PSBI were identified, 285 (40%) 7-59 days old infants had fast breathing (pneumonia), 141 (20%) 0-6 days old had fast breathing (severe pneumonia), 233 (33%) had signs of clinical severe infection (CSI), and 52 (7%) had signs of critical illness. Referral to a hospital was advised to 426 (60%) infants with CSI, critical illness or severe pneumonia. The referral was refused by 282 families who accepted simplified antibiotic treatment on an outpatient basis at the health centres. Treatment failure among those who received outpatient treatment occurred in 10/128 (8%) with severe pneumonia, 25/147 (17%) with CSI, including one death, and 2/7 (29%) young infants with a critical illness. Among 285 infants with pneumonia, 257 (90%) received oral amoxicillin treatment, and 8 (3%) failed treatment. Adherence to outpatient treatment was 98% to 100% for various PSBI sub-categories. Among 144 infants treated in a hospital, 8% (1/13) with severe pneumonia, 23% (20/86) with CSI and 40% (18/45) with critical illness died.ConclusionImplementation of the WHO PSBI guideline when a referral was not possible was feasible in our context with high coverage. Without financial and technical input to strengthen the health system at all levels, including the community and the referral level, it may not be possible to achieve and sustain the same high treatment coverage.

Background Globally, socioeconomic status (SES) is an important health determinant across a range of health conditions and diseases. However, measuring SES within low- and middle-income countries (LMICs) can be particularly challenging given the variation and diversity of LMIC populations. Objective The current study investigates whether maternal SES as assessed by the newly developed Global Network-SES Index is associated with pregnancy outcomes (stillbirths, perinatal mortality, and neonatal mortality) in six LMICs: Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan, and Zambia. Methods The analysis included data from 87,923 women enrolled in the Maternal and Newborn Health Registry of the NICHD-funded Global Network for Women’s and Children’s Health Research. Generalized estimating equations models were computed for each outcome by SES level (high, moderate, or low) and controlling for site, maternal age, parity, years of schooling, body mass index, and facility birth, including sampling cluster as a random effect. Results Women with low SES had significantly higher risks for stillbirth (p < 0.001), perinatal mortality (p = 0.001), and neonatal mortality (p = 0.005) than women with high SES. In addition, those with moderate SES had significantly higher risks of stillbirth (p = 0.003) and perinatal mortality (p = 0.008) in comparison to those with high SES. Conclusion The SES categories were associated with pregnancy outcomes, supporting the validity of the index as a non–income-based measure of SES for use in studies of pregnancy outcomes in LMICs.

BackgroundThe World Health Organization recommends inpatient hospital treatment of young infants up to two months old with any sign of possible serious infection. However, each sign may have a different risk of death. The current study aims to calculate the case fatality ratio for infants with individual or combined signs of possible serious infection, stratified by inpatient or outpatient treatment.MethodsWe analysed data from the African Neonatal Sepsis Trial conducted in five sites in the Democratic Republic of the Congo, Kenya and Nigeria. Trained study nurses classified sick infants as pneumonia (fast breathing in 7-59 days old), severe pneumonia (fast breathing in 0-6 days old), clinical severe infection [severe chest indrawing, high (> = 38°C) or low body temperature (2%) mortality risk.ResultsOf 7129 young infants with a possible serious infection, fast breathing (in 7-59 days old) was the most prevalent sign (26%), followed by high body temperature (20%) and severe chest indrawing (19%). Infants with pneumonia had the lowest case fatality ratio (0.2%), followed by severe pneumonia (2.0%), clinical severe infection (2.3%) and critical illness (16.9%). Infants with clinical severe infection had a wide range of case fatality ratios for individual signs (from 0.8% to 11.0%). Infants with pneumonia had similar case fatality ratio for outpatient and inpatient treatment (0.2% vs. 0.3%, p = 0.74). Infants with clinical severe infection or severe pneumonia had a lower case fatality ratio among those who received outpatient treatment compared to inpatient treatment (1.9% vs. 6.5%, p2%) (stopped feeding well, movement only when stimulated, low body temperature or multiple signs of clinical severe infection). We found that both categories had four times lower case fatality ratio when treated as outpatient than inpatient treatment, i.e., 1.0% vs. 4.0% (pConclusionsThe mortality risk differs with clinical signs. Young infants with a possible serious infection can be grouped into those with low-mortality risk signs (high body temperature, or severe chest indrawing or severe pneumonia); moderate-mortality risk signs (stopped feeding well, movement only when stimulated, low body temperature or multiple signs of clinical severe infection), or high-mortality risk signs (signs of critical illness). New treatment strategies that consider differential mortality risks for the place of treatment and duration of inpatient treatment could be developed and evaluated based on these findings.Clinical trial registrationThis trial was registered with the Australian New Zealand Clinical Trials Registry under ID ACTRN 12610000286044.