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Infant Development clinical trials

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NCT ID: NCT02701868 Completed - Childhood Obesity Clinical Trials

Unintentional Overfeeding of Formula Fed Infants

Whoa Baby
Start date: July 2016
Phase:
Study type: Observational

Although breast milk is recommended exclusively until 6 months of age, two-thirds of infants in the U.S. are fed infant formula. Despite an almost identical energy density between infant formula and breast milk, formula fed infants experience greater weight gain in the first year of life. The investigators propose that unintentional overfeeding, of nearly one additional day of calories per week, due to the "over-scooping" of powdered formula contributes significantly to this phenomenon and potentially to the early development of childhood obesity, a significant public health problem.

NCT ID: NCT02683473 Recruiting - Infant Development Clinical Trials

Measurement of Energy Metabolism in Infants

BabyEE Pilot
Start date: March 2016
Phase:
Study type: Observational

The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.

NCT ID: NCT02634749 Completed - Infant Development Clinical Trials

OTIS - Optimized Complementary Feeding Study

OTIS
Start date: April 1, 2015
Phase: N/A
Study type: Interventional

Dietary factors during infancy, e.g. high intakes of protein, fast carbohydrates and saturated fat increase the risk of adult obesity, type 2 diabetes and hypertension. However, current dietary recommendations to infants are based on traditions and experiences whereas research is basically lacking. Towards the end of the first year of life the infant will normally become increasingly suspicious towards fruits and vegetables. However, these foods are an important part of healthy eating. When and how these food items should be introduced into the diet of young children is unclear. New Nordic Diet, an initiative from the Nordic Council of Ministers calls for a larger intake of fruits, vegetables, whole grain, fish and game. In adults such diet improves weight and biomarkers of insulin resistance and cardiovascular disease. Since dietary preferences are founded early in life it is logical to introduce such a diet already when the child is starting complementary foods. In a randomized controlled study from 6 mo of age, we want to explore if a Nordic complementary diet with lower protein intake, more vegetable fats and a systematic introduction of fruits and greens will improve body composition, metabolic biomarkers, the composition of faecal microbiota (associated with obesity), cognitive development and the consumption of foods that can lay the foundation for better long-term diet. If the study has the expected results, these will have a direct impact on the dietary habits of Swedish children during infancy and childhood and thus their long-term health.

NCT ID: NCT02593825 Completed - Cerebral Palsy Clinical Trials

Efficacy of the START-Play Program for Infants With Neuromotor Disorders

START-Play
Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to improve development and readiness to learn in infants with motor delays or dysfunction. There is limited research examining the efficacy of early physical intervention on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the research demonstrating an association between motor activity and cognitive skills. START-Play specifically targets motor skills that lead to greater physical exploration, which has been associated with improved problem solving and global development. A randomized controlled trial of START-Play will be conducted across four states to investigate the impact of the intervention on changes over time in sitting and reaching, subsequent changes in global cognitive development, and the mediating influences of motor skill changes and problem solving. The research team will conduct a randomized controlled trial to evaluate the impact of START-Play on motor development, motor problem solving, global development including cognitive problem solving of infants with neuromotor delay and dysfunction. Infants will experience either the intervention or services as usual for 3 months, with following testing at three time points up until 9 months post intervention. The researchers will determine whether the intervention leads to improved sitting and reaching, which leads to improved motor-based problem solving, which leads to improved global development and problem solving.

NCT ID: NCT02290756 Recruiting - Infant Development Clinical Trials

A Community Based Implementation of a Toolkit and Parenting Program for Improving Brain Development in Newborns

Start date: January 2015
Phase: N/A
Study type: Interventional

The investigators propose to develop and test the efficacy of a low cost evidence based toolkit aimed at improving brain development among newborns a rural setting of Pakistan. The toolkit will include a safe delivery kit, nutritional supplementation, and trainings on cord care, hypothermia management, aspiration and bag and mask techniques and APGAR score calculation. A simple, home-based parenting program will also be implemented that will teach parents tools that provide stimuli for brain and cognitive development in children. This parenting program covers Early Childhood Interventions for children at risk of developmental problems and covers developmental skill areas such as cognitive and fine motor, social and self-help and gross motor skills. Such an intervention package provides comprehensive care to families at the community level, with a minimal cost that can be scaled up. A new cadre of Link workers will be implemented who will provide mentoring and supportive supervision to Birth Attendants and will train parents in the stimulation program. The study will recruit 1080 pregnant women and their newborns.

NCT ID: NCT02165956 Completed - Infant Development Clinical Trials

Effect of a New Infant Cereal on Weight Gain

CEOBE
Start date: March 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .

NCT ID: NCT02144402 Completed - Infant Development Clinical Trials

Growth of Healthy Term Infants Fed Formula Containing DHA-B

Start date: May 2014
Phase: N/A
Study type: Interventional

The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.

NCT ID: NCT02121496 Completed - Clinical trials for Postpartum Depression

Social Circumstances, Parenting Techniques, and Infant Development

Start date: March 2014
Phase: N/A
Study type: Interventional

1. Investigators aim to assess a novel behavioral intervention (currently approved in Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral changes in young infants to reduce the risk of postpartum depression in a group of low income women. More specifically, investigators aim to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior and thereby: (1) reduce the incidence and/or severity of postpartum maternal depression in low socioeconomic status (SES) women, and (2) improve the quality of mother-infant interaction and subsequent child development. Investigators will study: 1. The feasibility of applying this protocol with a low SES population 2. The effectiveness of the intervention compared to usual care 3. If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development 2. Investigators aim to determine whether this behavioral intervention can affect infant development as measured by neurodevelopmental assessments and cortisol reactivity at 4 months of age.

NCT ID: NCT02094547 Active, not recruiting - Infant Development Clinical Trials

A Neurocognitive and Immunological Study of a New Formula for Healthy Infants

COGNIS
Start date: December 2010
Phase: N/A
Study type: Interventional

To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula.

NCT ID: NCT02076204 Completed - Pregnancy Clinical Trials

Mother and Infant Home Visiting Program Evaluation-Strong Start

Start date: February 2014
Phase: N/A
Study type: Interventional

Adverse birth outcomes result in significant emotional and economic costs for families and communities. Research suggests that poor birth outcomes are influenced by a variety of social, psychological, behavioral, environmental, and biological factors. Home visiting programs represent a promising means of impacting each of these areas. The Mother and Infant Home Visiting Program Evaluation - Strong Start (MIHOPE-Strong Start) will evaluate the effectiveness of two evidence-based home visiting models at improving birth outcomes for women who are enrolled in Medicaid or CHIP. The two models to be studied - Healthy Families America (HFA) and Nurse-Family Partnership (NFP) - have both shown some evidence of improving birth outcomes in prior research. The overall goals of the study are to determine whether home visiting programs improve birth outcomes and reduce health care costs in the child's first year. In addition, the evaluation is designed to investigate the features of local programs and of home visitation that lead to greater effects on birth outcomes and health care costs. The study includes an impact analysis to measure what difference home visiting programs make on maternal prenatal health and health care use, preterm birth and other birth outcomes, and infant health and health care use. It also includes an implementation analysis that will describe the families who participate and examine how the program models operate in their local and state contexts. The primary data used in the study are expected to be from surveys completed by families and home visiting staff, Medicaid and CHIP data, vital records, and program service records. Among families who are eligible for the study, random assignment will be used to select families for enrollment in home visiting services. Those selected for home visiting services will form the program group, and those not selected will form a comparison group. The research team will monitor both groups over time to see if differences emerge in the outcome areas mentioned above. Although the study will affect which families can enroll in home visiting services, no fewer families will be served as a result of the study.