Association of Postpartum Maternal Morbidities with Children's Mental, Psychomotor and Language Development in Rural Bangladesh

Little is known from developing countries about the effects of maternal morbidities diagnosed in the postpartum period on children's development. The study aimed to document the relationships of such morbidities with care-giving practices by mothers, children's developmental milestones and their language, mental and psychomotor development. Maternal morbidities were identified through physical examination at 6-9 weeks postpartum (n=488). Maternal care-giving practices and postnatal depression were assessed also at 6-9 weeks postpartum. Children's milestones of development were measured at six months, and their mental (MDI) and psychomotor (PDI) development, language comprehension and expression, and quality of psychosocial stimulation at home were assessed at 12 months. Several approaches were used for identifying the relationships among different maternal morbidities, diagnosed by physicians, with children's development. After controlling for the potential confounders, maternal anaemia diagnosed postpartum showed a small but significantly negative effect on children's language expression while the effects on language comprehension did not reach the significance level (p=0.085). Children's development at 12 months was related to psychosocial stimulation at home, nutritional status, education of parents, socioeconomic status, and care-giving practices of mothers at six weeks of age. Only a few mothers experienced each specific morbidity, and with the exception of anaemia, the sample-size was insufficient to make a conclusion regarding each specific morbidity. Further research with a sufficient sample-size of individual morbidities is required to determine the association of postpartum maternal morbidities with children's development

Association of Postpartum Maternal Morbidities with Children's Mental, Psychomotor and Language Development in Rural Bangladesh

Little is known from developing countries about the effects of maternal morbidities diagnosed in the postpartum period on children's development. The study aimed to document the relationships of such morbidities with care-giving practices by mothers, children's developmental milestones and their language, mental and psychomotor development. Maternal morbidities were identified through physical examination at 6-9 weeks postpartum (n=488). Maternal care-giving practices and postnatal depression were assessed also at 6-9 weeks postpartum. Children's milestones of development were measured at six months, and their mental (MDI) and psychomotor (PDI) development, language comprehension and expression, and quality of psychosocial stimulation at home were assessed at 12 months. Several approaches were used for identifying the relationships among different maternal morbidities, diagnosed by physicians, with children's development. After controlling for the potential confounders, maternal anaemia diagnosed postpartum showed a small but significantly negative effect on children's language expression while the effects on language comprehension did not reach the significance level (p=0.085). Children's development at 12 months was related to psychosocial stimulation at home, nutritional status, education of parents, socioeconomic status, and care-giving practices of mothers at six weeks of age. Only a few mothers experienced each specific morbidity, and with the exception of anaemia, the sample-size was insufficient to make a conclusion regarding each specific morbidity. Further research with a sufficient sample-size of individual morbidities is required to determine the association of postpartum maternal morbidities with children's development

The Benefits and Risks of Iron interventionS in Children (BRISC) trial: Statistical analysis plan

Background: The Benefits and Risks of Iron interventionS in Children (BRISC) trial will evaluate the impact of universal supplementation with iron supplements or iron-containing multiple micronutrient powders (MNPs) compared with placebo given for 3 months on child development, growth, morbidity, laboratory indices of anaemia, iron deficiency, and inflammation at end of intervention and after a further 9 months post intervention in children aged 8 months living in rural Bangladesh. This paper describes the statistical analysis plan. Methods: BRISC is a multi-site, three-arm, double-dummy blinded, parallel group, randomised control superiority trial in 3300 children. The statistical analysis plan was developed by the trial statistician in consultation with the trial steering committee and trial management committee based on the protocol, data collection forms, and study outcomes available in the blinded study database.   Conclusion: This detailed statistical analysis plan published prior to unblinding the allocated treatments will support the statistical analyses and reporting of the BRISC trial to be undertaken after unblinding. It allows for transparency as well as reproducibility of statistical analyses and reporting. Registration: Australian New Zealand Clinical Trials Registry ACTRN12617000660381 (registered on 8 May 2017); World Health Organization Universal Trial Number U1111-1196-1125

Using a Developmental Test and Electroencephalography to Examine Child Cognition and Its Predictors in Bangladesh (P13-024-19)

Objectives: The majority of global health studies use behavioural assessments to measure early child development. Few studies have examined neural indices of cognition using electroencephalography (EEG) in low-income settings. Using data from the Benefits and Risks of Iron Supplementation in Children (BRISC) trial, we examined cognitive development and neural indices of memory and attention in 11 month-old Bangladeshi children and their environmental, socio-demographic, and biological predictors. Methods: At 8 months of age, 3300 children were randomized to iron syrup, multiple micronutrient supplementation, or placebo for 3 months. The main trial outcomes include child development measured using the Bayley Scales of Infant and Toddler Development (BSID)-III, anthropometry, haemoglobin, morbidity, and iron indices. EEG is being conducted to measure event-related brain potentials (ERPs) in a random subset of 250 children at 11 months of age. ERPs are measured in response to auditory and visual stimuli, using roving oddball and attention orienting tasks. Generalized linear mixed models estimated the predictors of BSID-derived cognitive development and EEG-derived neural indices of memory and attention. Potential predictors include psychosocial stimulation, anthropometry, haemoglobin, socio-economic status, food security, sex, and parental education. Additionally, we examined correlations between the BSID cognitive scores and EEG-derived neural indices of cognition. Results: Preliminary BSID data up to December 2018 indicates that 1749 children have completed measurements at 11 months of age. Psychosocial stimulation was significantly associated with BSID cognitive development scores. ERPs in children at 11 months of age are expected to be completed by May 2019 and relevant results will be presented. Conclusions: This study is the first to acquire ERP data in children at 11 months of age in rural Bangladesh. Our findings will identify significant predictors of cognitive functioning measured using the BSID (a well-established developmental test) and using EEG (a sensitive neurophysiological approach) in young children in this setting. Results will indicate the agreement between child cognition outcomes using the BSID and EEG. Funding Sources: NHMRC and The University of Melbourne

Immediate impact of stay-at-home orders to control COVID-19 transmission on socioeconomic conditions, food insecurity, mental health, and intimate partner violence in Bangladeshi women and their families: an interrupted time series

BACKGROUND: Stay-at-home orders (lockdowns) have been deployed globally to control COVID-19 transmission, and might impair economic conditions and mental health, and exacerbate risk of food insecurity and intimate partner violence. The effect of lockdowns in low-income and middle-income countries must be understood to ensure safe deployment of these interventions in less affluent settings. We aimed to determine the immediate impact of COVID-19 lockdown orders on women and their families in rural Bangladesh. METHODS: An interrupted time series was used to compare data collected from families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown. We also assessed women's experiences of intimate partner violence during the pandemic. RESULTS: Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent. 2414 (99·9%, 95% CI 99·6-99·9) of 2417 mothers were aware of, and adhering to, the stay-at-home advice. 2321 (96·0%, 95·2-96·7) of 2417 mothers reported a reduction in paid work for the family. Median monthly family income fell from US$212 at baseline to$59 during lockdown, and the proportion of families earning less than $1·90 per day rose from five (0·2%, 0·0-0·5) of 2422 to 992 (47·3%, 45·2-49·5) of 2096 (p<0·0001 comparing baseline with lockdown period). Before the pandemic, 136 (5·6%, 4·7-6·6) of 2420 and 65 (2·7%, 2·1-3·4) of 2420 families experienced moderate and severe food insecurity, respectively. This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001). Mothers' depression and anxiety symptoms increased during the lockdown. Among women experiencing emotional or moderate physical violence, over half reported it had increased since the lockdown. INTERPRETATION: COVID-19 lockdowns present significant economic, psychosocial, and physical risks to the wellbeing of women and their families across economic strata in rural Bangladesh. Beyond supporting only the most socioeconomically deprived, support is needed for all affected families. FUNDING: National Health and Medical Research Council, Australia

Benefits and Risks of Iron Interventions in Infants in Rural Bangladesh

BACKGROUND: Universal provision of iron supplements (drops or syrup) or multiple micronutrient powders to young children in low-to-middle-income countries where anemia is prevalent is recommended by the World Health Organization and widely implemented. The functional benefits and safety of these interventions are unclear. METHODS: We conducted a three-group, double-blind, double-dummy, individually randomized, placebo-controlled trial to assess the immediate and medium-term benefits and risks of 3 months of daily supplementation with iron syrup or iron-containing multiple micronutrient powders, as compared with placebo, in 8-month-old children in rural Bangladesh. The primary outcome was cognitive development, as assessed by the cognitive composite score on the Bayley Scales of Infant and Toddler Development, third edition, immediately after completion of the assigned 3-month regimen; scores range from 55 to 145, with higher scores indicating better cognitive performance. Secondary outcomes included the cognitive composite score at 9 months after completion of the assigned regimen; behavioral, language, and motor development, as well as growth and hematologic markers, immediately after completion and at 9 months after completion; and safety. RESULTS: We randomly assigned 3300 infants to receive iron syrup (1101 infants), multiple micronutrient powders (1099), or placebo (1100) daily. After completion of the assigned 3-month regimen, no apparent effect on the cognitive composite score was observed with iron syrup as compared with placebo (mean between-group difference in change in score from baseline, -0.30 points; 95% confidence interval [CI], -1.08 to 0.48) or with multiple micronutrient powders as compared with placebo (mean between-group difference in change in score from baseline, 0.23 points; 95% CI, -0.55 to 1.00). No apparent effect on any other developmental or growth outcome was observed immediately after completion of the assigned regimen or at 9 months after completion. At 9 months after completion of the assigned regimen, the prevalences of anemia, iron deficiency, and iron deficiency anemia increased in all three trial groups but remained lower among the children who received iron syrup or multiple micronutrient powders than among those who received placebo. The risk of serious adverse events and incidence of symptoms of infection were similar in the three trial groups. CONCLUSIONS: In this trial involving infants in Bangladesh, 3 months of daily supplementation with iron syrup or multiple micronutrient powders did not appear to have an effect on child development or other functional outcomes as compared with placebo. (Funded by the National Health and Medical Research Council of Australia; BRISC Australian New Zealand Clinical Trials Registry number, ACTRN12617000660381.)