RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study.

BACKGROUND: Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. It induces preterm births and low birth weight (LBW) deliveries, long-term neurodevelopmental sequelae, and an increased risk of earlier onset of postnatal iron deficiency. Anemia rates are among the highest in South Asia, and India's National Family Health Survey (NFHS-5) for 2019-2021 indicated that over half of pregnant women, and more than 65% of children, in the country are classified as anemic (Sciences IIfP, National Family Health Survey-5, 2019-21, India Fact Sheet). In 2021, the parent RAPIDIRON Trial (Derman et al., Trials 22:649, 2021) was initiated in two states in India, with the goal of assessing whether a dose of intravenous (IV) iron given to anemic women during early pregnancy results in a greater proportion of participants with normal hemoglobin concentrations in the third trimester and a lower proportion of participants with LBW deliveries compared to oral iron. As a follow-up to the RAPIDIRON Trial, the RAPIDIRON-KIDS Study will follow the offspring of previously randomized mothers to assess, neurobehavioral, hematological, and health outcomes. METHODS: This prospective observational cohort study will follow a subset of participants previously randomized as part of the RAPIDIRON Trial and their newborns. Study visits occur at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months and include blood sample collection with both maternal and infant participants and specific neurobehavioral assessments conducted with the infants (depending on the study visit). The primary outcomes of interest are (1) infant iron status as indicated by both hemoglobin and ferritin (a) at birth and (b) at 4 months of age and (2) the developmental quotient (DQ) for the cognitive domain of the Bayley Scales of Infant Development Version IV (BSID-IV) at 24 months of age. DISCUSSION: This RAPIDIRON-KIDS Study builds upon its parent RAPIDIRON Trial by following a subset of the previously randomized participants and their offspring through the first 3 years of life to assess neurodevelopmental and neurobehavioral (infants, children), hematological, and health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05504863 , Registered on 17 August 2022. Clinical Trials Registry - India CTRI/2022/05/042933 . Registered on 31 May 2022.

Effect of Occupational Exposure on Blood Cell Counts, Electrocardiogram and Blood Pressure in Rice Mill Workers.

INTRODUCTION: Under normal conditions, parasympathetic and sympathetic nervous systems interact to regulate the heart rate of about 70 beats per minute. Activation of sympathetic nervous system by emotional or physical stress increases heart rate and the force of heart beat. There are many factors which alter the heart rate. The chemical and mechanical stimulation of receptors can also cause change in blood pressure through autonomic nervous system. Exposure to dust also causes alteration in blood cell counts. This can be due to allergic reactions and inflammation which in turn evoked by dust entering the lungs. OBJECTIVES: Aim of the study was to evaluate the effect of occupational exposure on haematological and cardiovascular parameters of rice mill workers by analysing Blood Cell Counts, ECG and Blood Pressure. MATERIALS AND METHODS: This cross-sectional study was carried on 134 rice mill workers and an equal number of age and sex matched healthy individual. The blood cell counts were determined by automated cell counter machine, ECG was recorded by using ECG machine and Blood Pressure was measured by using mercurial sphygmomanometer. RESULTS: Neurtrophil, Eosinophil and Lymphocyte count among haematological parameters were significantly increased in exposed individuals. Marked variation was seen in ECG and Blood pressure among cardiovascular parameters of exposed individuals compared with control group. CONCLUSION: The findings of our study clearly indicate that the rice mill workers are under high level of dust exposure which has deleterious effects on their blood and tissues. It is due to high oxidative stress. There are abnormalities seen in cardiovascular system.