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.

Tobacco use and Oral Premalignant Lesions among Auto-Rickshaw Drivers in Belagavi, North Karnataka.

Background: Auto-rickshaw drivers (ARDs) are under constant physical and mental pressure due to illiteracy, poverty, lack of awareness about hazards of addictions, and other factors that lead to various habits majority being tobacco use. Studies have found that tobacco use is very prevalent among ARDs in comparison to general population. Tobacco use is commonly associated with cancers. Oral Pre-Malignant Lesions (OPMLs) are the strongest risk factor for majority of oral cancers. We studied the prevalence of OPML among ARDs of Belagavi and their association with tobacco use. Methods: It was a cross-sectional study conducted among 600 regular ARDs of Belagavi City during January to December 2016. We selected two ARDs that were the last in line from 300 major auto-rickshaw stands. We adapted the questionnaire from Global Adult Tobacco Survey questionnaire. After getting informed consent, we collected the data by personal interview and performed an oral visual examination for OPML for all the study participants. Data were analyzed using SPSS software. Institutional Ethics Committee approved the study. Results: Prevalence of tobacco was 62.17%. One-third of participants (30.17%) had OPMLs. Leukoplakia (62.43%) was the most common lesion. OPMLs were significantly associated with tobacco use and duration of tobacco use. Conclusions: About 30% of ARDs had an OPML. Chewing tobacco, gutkha, lime with tobacco, and cigarette were significantly associated with OPML.