PLoS medicine
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Randomized Controlled Trial
Prenatal fortified balanced energy-Protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial.
Providing balanced energy-protein (BEP) supplements is a promising intervention to improve birth outcomes in low- and middle-income countries (LMICs); however, evidence is limited. We aimed to assess the efficacy of fortified BEP supplementation during pregnancy to improve birth outcomes, as compared to iron-folic acid (IFA) tablets, the standard of care. ⋯ The MISAME-III trial did not provide evidence that fortified BEP supplementation is efficacious in reducing SGA prevalence. However, the intervention had a small positive effect on other birth outcomes. Additional maternal and biochemical outcomes need to be investigated to provide further evidence on the overall clinical relevance of BEP supplementation.
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Randomized Controlled Trial
Evaluation of multiple micronutrient supplementation and medium-quantity lipid-based nutrient supplementation in pregnancy on child development in rural Niger: A secondary analysis of a cluster randomized controlled trial.
It is estimated that over 250 million children under 5 years of age in low- and middle-income countries (LMICs) do not reach their full developmental potential. Poor maternal diet, anemia, and micronutrient deficiencies during pregnancy are associated with suboptimal neurodevelopmental outcomes in children. However, the effect of prenatal macronutrient and micronutrient supplementation on child development in LMIC settings remains unclear due to limited evidence from randomized trials. ⋯ There was no benefit of prenatal MMS on child development outcomes up to 2 years of age as compared to IFA. There was evidence of an apparent positive effect of prenatal LNS on cognitive development trajectory and time to achievement of selected gross motor milestones.
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Randomized Controlled Trial
The effect of a therapeutic smartphone application on suicidal ideation in young adults: Findings from a randomized controlled trial in Australia.
Suicidal ideation is a major risk for a suicide attempt in younger people, such that reducing severity of ideation is an important target for suicide prevention. Smartphone applications present a new opportunity for managing ideation in young adults; however, confirmatory evidence for efficacy from randomized trials is lacking. The objective of this study was to assess whether a therapeutic smartphone application ("LifeBuoy") was superior to an attention-matched control application at reducing the severity of suicidal ideation. ⋯ LifeBuoy was associated with superior improvements in suicidal ideation severity, but not secondary mental health outcomes, compared to the control application, LifeBuoy-C. Digital therapeutics may need to be purposefully designed to target a specific health outcome to have efficacy.
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Randomized Controlled Trial
Vitamin D3 supplementation during pregnancy and lactation for women living with HIV in Tanzania: A randomized controlled trial.
Observational studies suggest that vitamin D deficiency among people living with HIV is associated with a greater risk of disease progression and death. Low levels of vitamin D in pregnancy are also associated with poor fetal and infant growth. Therefore, vitamin D supplementation may improve clinical outcomes for pregnant women living with HIV and improve fetal and postnatal growth for their infants. ⋯ The trial findings do not support routine vitamin D supplementation for pregnant and lactating women living with HIV in Tanzania.
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Randomized Controlled Trial
Brain-based measures of nociception during general anesthesia with remifentanil: A randomized controlled trial.
Catheter radiofrequency (RF) ablation for cardiac arrhythmias is a painful procedure. Prior work using functional near-infrared spectroscopy (fNIRS) in patients under general anesthesia has indicated that ablation results in activity in pain-related cortical regions, presumably due to inadequate blockade of afferent nociceptors originating within the cardiac system. Having an objective brain-based measure for nociception and analgesia may in the future allow for enhanced analgesic control during surgical procedures. Hence, the primary aim of this study is to demonstrate that the administration of remifentanil, an opioid widely used during surgery, can attenuate the fNIRS cortical responses to cardiac ablation. ⋯ We observed cortical activity related to nociception during cardiac ablation under general anesthesia with remifentanil. It highlights the potential of fNIRS to provide an objective pain measure in unconscious patients, where cortical-based measures may be more accurate than current evaluation methods. Future research may expand on this application to produce a real-time indication of pain that will aid clinicians in providing immediate and adequate pain treatment.