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Child Development clinical trials

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NCT ID: NCT02645162 Recruiting - Child Development Clinical Trials

Youth Leaders for Early Childhood Assuring Children Are Prepared for School

LEAPS
Start date: December 2015
Phase: Phase 3
Study type: Interventional

Worldwide about 88 million children drop out of primary school annually. One of the contributory factors is a lack of school readiness among young children, their families and their teachers. To better prepare young children for school, investment in early childhood interventions is necessary. Young children require good health, adequate nutrition and social-emotional, cognitive and communication skills to succeed in school, which requires both support in the family environment and a stable transition to the classroom environment. Preschool programmes are designed to prepare children for formal learning. However, in many low- and middle-income countries there is poor access to quality preschool programmes. Further, the scale-up of early childhood interventions is challenged by a number of barriers such as poor supply (e.g. policy provisions, financing, distance, early child development workforce), inadequate cross-sector coordination, low demand (e.g. knowledge mobilization, agency, community of purpose, opportunities to participate) and weak quality of services (e.g. training, supervision and monitoring systems). In partnership with the National Commission for Human Development, we propose to implement an early childhood care and education programme in rural Sindh that is championed by Community Youth Leaders. The Community Youth Leaders will run community preschools for children aged 3-6 years, and will also coordinate local community engagement and local stakeholder strategies across sectors to leverage demand-side actions to promote ownership and scale-up of early childhood interventions. The LEAPS Programme (Youth Leaders for Early Childhood Assuring Children are Prepared for School) will be evaluated by a cluster randomized controlled efficacy trial. The primary outcome will be children's school readiness, indexed by both early academic and social emotional competencies assessed following 6-9 months of intervention exposure. The compliance, fidelity and quality of the implementation process will also be assessed in order to understand how these features moderate outcomes and whether community-engagement strategies facilitate demand-side actions for scale-up. The expected outcomes for this trial will include a model for quality preprimary education that addresses a current supply-side gap, and will facilitate learning for demand-side actions to support scale-up across a broad range of early childhood interventions.

NCT ID: NCT02550236 Recruiting - Child Development Clinical Trials

LIFE Child (LIFE Leipzig Research Centre for Civilization Diseases)

Start date: October 2010
Phase:
Study type: Observational

The Leipzig Research Centre for Civilization Diseases (LIFE) Child Study is a prospective longitudinal population-based study with a life course approach to health and disease. The LIFE Child Study focuses on two main research objectives: - What are premises of normal growth, development and health in children? - Which factors contribute to the development of non-communicable diseases such as childhood obesity and its co-morbidities, atopy and mental health problems? Detailed assessments will be conducted alongside long-term storage of biological samples in 1,000 pregnant women and more than 5,000 children and their families.

NCT ID: NCT02059863 Recruiting - Child Development Clinical Trials

SPRING Cluster Randomised Controlled Trial

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

A large number of children in developing countries lack access to known effective interventions. Almost 9 million die each year before reaching their fifth birthday, and over 200 million children who survive fail to achieve their full growth or developmental potential, trapping them in a cycle of continuing disadvantage. The goal of "SPRING", Sustainable Programme Incorporating Nutrition and Games, is to develop an innovative approach to close this access gap, in two of the worst affected countries India and Pakistan, using community based agents. Extensive formative research will be carried out to help ensure that the content and approach of the "SPRING" intervention is feasible, acceptable and appropriately targeted. Findings will be reviewed at an intervention development workshop with local and international stakeholders and experts, and the agreed intervention piloted with a few community based agents and their supervisors. Cluster randomised controlled trials will be carried out in each setting to evaluate the impact of "SPRING" on child growth, development and survival. The programme will include process and economic evaluations to provide information on the total cost of the intervention and its cost effectiveness, as well as development of a framework with lessons learned for implementing "SPRING" in other settings.

NCT ID: NCT00980733 Recruiting - Child Development Clinical Trials

Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits

Start date: September 2008
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of consumption of yoghurt fortified with 30% recommended dietary allowance (RDA) of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year in comparison to same yoghurt without fortification for change in mean levels and proportion deficient for markers of status of Iron (Hemoglobin, Serum ferritin, Serum transferrin, ZnPP), Vitamin A (Plasma retinol levels), Iodine (Urinary iodine levels), Zinc (Plasma zinc), and copper (Plasma copper levels, sub sample of children); improvement in cognitive development, reduction in episodes/days of illnesses (diarrhea, pneumonia, febrile illness), hospitalizations and morbidity causing absenteeism from school and improvement in growth. Additionally to evaluate the efficacy of consumption of fortified and non fortified yoghurt (plain yoghurt) for a period of 12 months in comparison to pure control that do not receive any intervention in the improvement in cognitive development and physical growth. The main objective is to evaluate the impact of addition of micronutrients to Yoghurt and can be best addressed by RCT. The effect of taking yoghurt per se cannot be blinded so for that the investigators have included a concurrent control. Hypothesis: Consumption of fortified yoghurt with 30% RDA of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year will improve the micronutrient status indicators, cognitive development, and growth and reduce morbidity of children.