Clinical Research Directory

Stress Reactivity and Mother-Infant Cardiovascular Disease Risk

Prenatal Mindfulness training (MT) shows promise as a preventive intervention against hypertensive disorders of pregnancy (HDP) and may reduce risk for offspring cardiovascular disease (CVD). One proposed mechanism of MT to reduced CVD risk is improved self-regulation following stress. Perhaps the most crucial contributor to the development of self-regulation in the first year is the psychophysiological coregulatory relationship between mother and infant. However, this self-and co-regulation among women exposed to prenatal MT has not been studied and has yet to be examined in relation to CVD risk. The goal of this proposed project is to evaluate maternal-infant physiological reactivity to and recovery from stress at 6 months postpartum following prenatal MT, and to examine the relationship between these maternal infant stress responses and maternal-infant CVD risk at 12 months postpartum. Using a lab-based stress paradigm and well-validated biomarkers of mother and infant CVD risk, the investigators will assess respiratory sinus arrhythmia and heart rate at 6 months postpartum for 40 mother-infant dyads who have completed either prenatal MT or a usual care arm of an RCT examining MT for women at risk for HDP. The investigators will compare maternal, infant, and dyadic stress responses by treatment arm. Then, cardiac stress responses will be examined as predictors of maternal and infant biomarkers of CVD risk at 12 months postpartum.

Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants

This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.

Infant Development and Early Aquatic Stimulation

The objective of this study is to assess the feasibility of an aquatic stimulation protocol for infants up to one year of age. The main questions to be answered are: Is the aquatic stimulation program, which involves recruitment, intervention, and reassessment, feasible and feasible on a larger scale? Was the aquatic stimulation protocol able to promote improvements in child development compared to the control group? Researchers will compare the intervention group with a control group, which will be included on the waiting list, to determine whether aquatic stimulation promotes improved child development. Eligible participants will be assessed, and then a random selection will be made by an independent researcher to determine the control and experimental groups. The experimental group will receive aquatic stimulation through a group class, with activities that stimulate language, cognitive, fine and gross motor skills, as well as social interaction. The control group will remain on the waiting list throughout the intervention. Monthly messages will be sent to both groups to collect information about the infant's health. Interventions will occur twice a week for 45 minutes over a three-month period. Immediately afterward, the children and their parents/guardians will be reevaluated. Children in the control group will be guaranteed a spot to receive aquatic stimulation after the intervention period. The data will be tabulated, analyzed, and subsequently published scientifically.

Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults. The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

Effect of a Mobile Health Intervention on Birth Outcome and Infant Health

Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight, preterm birth, and challenges in child growth and development. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Despite global efforts to improve maternal, newborn, and child health, adverse birth outcomes remain significant challenges, particularly in low and middle-income countries (LMICs). A noteworthy observation is that not all pregnant women modify their behaviors for their and their baby's health due to lack of social support, fear and insecurity. Recognizing the potential for interventions during pregnancy to positively influence maternal, fetal, and neonatal health, this research underscores the role of Mobile Health (mHealth) technologies in leveraging information and communication technology for health service delivery. Accordingly, the study aims to evaluate the effect of mobile health intervention on birth outcomes and infant health in Nepal. In the initial phase, a qualitative study will be conducted to explore the enablers and barriers of perinatal care and preferences of pregnant women through focus group discussions. These insights will inform the development of user-centered educational videos and tailored m-Health interventions for pregnant women. A two-arm parallel randomized controlled trial will then assess the m-Health intervention's effect on the birth outcomes and infant health of the pregnant women attending the antenatal care clinic of Dhulikhel Hospital. The investigaotors will randomize pregnant women at gestational age 14-22 weeks into either a control group (who will receive standard care along with a control video and reminder phone call for follow-up) or an intervention group (who will receive standard care along with m-health intervention that includes educational video, short message service (SMS) and reminder phone call for follow up). Follow-up will be done from enrollment until the child reaches one year of age, with a focus on evaluating effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery) and infant health (growth and development of the infant). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analyzed using STATA 14, contributing valuable insights into the potential effect of m-Health intervention on birth outcomes and infant health.