View clinical trials related to Birth Weight.
Filter by:Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Both micro and macro-nutrients are required for the physiological changes and increased metabolic demands during pregnancy, including fetal growth and development. Women in Bangladesh have poor diets and are struggling to meet their nutrient requirements, especially during pregnancy and lactation when requirements are higher. Maternal undernutrition during pregnancy is associated with a range of adverse birth outcomes, including stillbirths, preterm births, low birthweight, and small-for-gestational-age (SGA) neonates, all of which remain unacceptably high in Bangladesh. Social protection provides a promising platform on which to leverage improvements in nutrition at scale, but current evidence on the impacts of social protection on birth outcomes is limited: few studies have been conducted and some of these studies suffer from methodological limitations. The planned study will contribute to filling this knowledge gap. An additional motivation for the study is provided by the recent WHO 2016 Antenatal Care Guidelines. The guidelines call for studies on the effectiveness of alternatives to providing energy and protein supplements to pregnant women (which is recommended in undernourished populations). Studying the effectiveness of providing combinations of food and cash will help build this evidence base. A third reason to conduct the study is that both food transfers and cash transfers are commonly used policy instruments in Bangladesh, and the choice of intervention components to scale up in the CBP will be guided by the findings from this pilot study. The study findings will thus be highly policy relevant. A three-arm cluster-randomized, non-masked, community-based, longitudinal trial will be used. Groups of pregnant women will be randomly assigned to one of three study arms providing different combinations of cash and food transfers.
The purpose of this study is to evaluate the impact of Benazir Nashonuma Program (BNP) which includes specialized nutritious food (SNF) augmented with specific reproductive health interventions during pregnancy on proportion of low birthweight babies and stunting among children, in low income setting of Pakistan. The study aims to answer if: 1. Utilization of Benazir Nashonuma Program (BNP) among pregnant women is effective in reducing the proportion of low birthweight babies, compared to pregnant women who are not utilizing the program, among low income setting population. 2. Utilization of Benazir Nashonuma Program (BNP) is effective in reducing the proportion of stunting among children, compared to those not utilizing the program, among low income setting population. Participants who are enrolled in the Benazir Nashonuma Program (receiving intervention) and those who are not enrolled (not receiving intervention) will be followed throughout pregnancy till delivery. After delivery mother-baby dyad will be followed for a period of 12 months. Compliance of supplementation will be measured, and outcomes (low birthweight and stunting) observed throughout the follow up.
The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth weight, small for gestational age, preterm, fetal loss, or neonatal death.
This study continues an adaptation of the behavioral intervention Care Coordination After Preterm Birth (CCAPB). This is a pragmatic pilot randomized controlled feasibility trial of CCAPB with baseline and post-intervention assessments.
The aim of the DenBalo study is to apply integrated multi-omics methods to examine the biological mechanisms underlying this vulnerability in Small Vulnerable Newborns (SVNs) in LMICs, with the ultimate goal of identifying targeted interventions to reduce morbidity and mortality in this high-risk population. The evidence generated from this project will ultimately help promote healthy pregnancies and the birth of healthy babies. To achieve this goal, three research objectives are proposed: 1. To describe and compare gut microbiota, immune system and breastmilk components in SVNs versus healthy community controls in urban Burkina Faso. 2. To describe and compare the development of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso. 3. To investigate the relationship between the composition of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso.
The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are <28 weeks gestational age (GA) or <1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).
The primary aim of the study is to evaluate the effect of fortified balanced energy and protein (BEP) supplementation vs. control (multiple micronutrient supplement, MMS) without targeting and with targeting (either by low prepregnancy BMI or low prepregnancy BMI and inadequate gestational weight gain) on birth weight and adverse birth outcomes of low birth weight (LBW < 2500 g) and small-for-gestational age (SGA). To do this we are proposing a cluster-randomized, open labeled effectiveness trial with four arms The main question[s] it aims to answer are: • Does mean birth weight and rate of LBW and SGA differ among mothers randomized to four arms that include targeted or untargeted BEP supplementation vs. MMS differ. Participants will be recruited in early pregnancy and be enrolled in the trial and randomly receive: 1. A daily BEP supplement from enrollment until birth 2. A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement 3. A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement or get switched to a BEP supplement based on inadequate gestational weight gain. Researchers will compare the above groups to women receiving a MMS daily to see if birth weight is higher in the intervention arms. Other adverse outcomes such as low birth weight, small-for-gestational age and preterm birth will also be compared between groups and relative to the control.
This project-also known as "Accountability for Care through Undoing Racism & Equity for Moms" or ACURE4Moms-aims to reduce Black-White maternal health disparities using multi-level interventions designed to decrease bias in prenatal care, improve care coordination, and increase social support. ACURE4Moms is a pragmatic 4-arm cluster randomized controlled trial conducted with 40 prenatal practices across North Carolina. Practices will be randomly assigned to receive either: Arm 1 (Standard Care): North Carolina Medicaid Care management for high-risk pregnancies; Arm 2 (Data Accountability and Transparency): North Carolina Medicaid Care Management + Practice-level Data Accountability interventions; Arm 3 (Community-Based Doula Support): North Carolina Medicaid Care Management + Community-Based Doula support intervention for high-risk patients during pregnancy and postpartum; or Arm 4 (Data Accountability and Transparency + Community-Based Doula Support): North Carolina Medicaid Care Management + Both Arms 2 and 3 interventions. During each practice's 2-year intervention period, the practice will initiate prenatal care for ~750 patients (30,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.
Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment. Standard fortification of human milk is routine in most neonatal units in North America, but despite the added nutrients, infants are often discharged from hospitals with poor growth, and their neurodevelopment remains suboptimal. Two individualized fortification methods, target and BUN adjustable, have been proposed to improve the nutrient supply to infants. However, there is currently insufficient evidence to support the implementation of individualized fortification or one method over the other. Therefore, this study will randomly assign very low birth weight infants to receive feeds fortified according to standard, target or BUN adjustable fortification methods until 36 weeks gestational age or hospital discharge whichever occurs first. Feedings will be prepared in milk preparation rooms to ensure caregivers and outcomes assessor remain blinded to feeding allocation. Growth, morbidities, and nutrient intakes will be determined throughout hospitalization and skinfolds assessed at 36 weeks. At 4 months CA, growth and body composition will be determined by air displacement plethysmography and processing speed by electroencephalography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.
The aim of the study is to determine the preferred oximeter averaging setting during automated control of FiO2 (A-FiO2) in infants receiving respiratory support and supplemental oxygen.