300,000+ clinical trials. Find the right one.

62 active trials for Child Development

THRIVE BY 3 Daycare to Promote Development/ Mental Health in 1&2 Year-olds

This study evaluates a preventive, knowledge enhancement and tailored quality building intervention to promote development and mental health in 1 and 2 year-olds. Half of the participating childcare centers will get the intervention (intervention group) and half will get the intervention after 1 year (waitlist-control).

Start: October 2017

FamilieTrivsel i Almen Praksis: a Mentalisation Programme for Families With Young Children

This cluster randomised trial aims to establish the effectiveness of an online intervention designed to improve the ability of parents to 'mentalise' - in other words to understand their own mental states and that of others including their partners and young children. Effects on maternal mental state, the quality of parent-child interaction and child language, social and emotional development will be assessed.

Start: October 2019

Muscle Wasting in Children and Adolescents With Cancer

The series of the 3-year study aims to explore parents' experience of caring for a child's weight change among parents of children and adolescents with cancer, examine the associations and trends among muscle wasting and health-related variables, and then implement and assess effectiveness of a multidisciplinary approach with a personalized physical activity (walking) training intervention on improving muscle mass and other health-related variables.

Start: August 2020

LIFE Leipzig Research Centre for Civilization Diseases

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.

Start: October 2010

Mother-infant Bonding During COVID-19

The purpose of this study is to compare the mother-infant emotional connection formed during the pandemic in standard care (SC) versus Family Nurture Intervention (FNI) pairs, an evidence-based intervention designed to counteract the adverse effects of maternal-infant disconnection. In prior research on preterm infants in the neonatal intensive care unit (NICU), FNI participants demonstrated increased quality of maternal caregiving behaviors and significant improvements in premature infants' neurodevelopment across multiple domains, including social-relatedness and attention problems. Goals of FNI include assisting mothers in providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development as well as reducing stress physiology in both mother and infant. Data gathered in this study will help the investigators learn more about the underlying mechanisms that take place during mother-infant interactions and examine how these play a role in setting the infant up for the best neurodevelopmental trajectory. Intervention will be conducted electronically both in the Well Baby Nursery (WBN) and at home over the following 4 months. Assessments will consist of videos of mother-infant interactions at the time of each intervention session, and pediatrician-led follow-up surveys conducted in the linked Institutional Review Board-approved study.

Start: August 2020

The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants

This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the nutritive effects of two staged study formulas on growth and cognitive outcomes. Approximately 450 participants will be enrolled with the expectation of having 105 participants per group (315 for three groups: control group, investigational group, and breastfeeding reference group ) complete Study Visit 6 at 365 days of age ± 7 days (allowing for a 30% drop-out rate). Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age. The study period will include feeding up to 365 days of age and cognitive testing up to 365 days of age. Stool samples will be collected from a subset of participants at enrollment and at 120 days of age for fecal microbiome analysis.

Start: August 2020

CrescNet - Growth Monitoring Network

CrescNet is a network of primary care physicians and pediatricians (n=219) and endocrinological treatment centers (n=33), established in Leipzig in 1998, whose aim is to improve the early detection of growth disorders. Secondary to this clinical aim, epidemiological analyses, for example on secular trends of growth data of children, are performed.

Start: January 1998

Mobile Health (mHealth) Tools to Improve Delivery Quality of a Family Home Visiting Intervention

The proposed exploratory research will pilot a family-focused, behavioral health intervention while also developing and piloting innovative and cost-effective mHealth tools to support Community Health Workers (CHWs) in Sierra Leone. This dual focus will help build capacity both for delivery of evidence-based mental health services to reduce family violence and harsh parenting practices, and for effective use of mHealth strategies to improve healthcare delivery and quality. This study will leverage Government of Sierra Leone investments in community health initiatives and mHealth innovations as a strategy to address critical healthcare workforce limitations that plague delivery of evidence-based interventions to vulnerable families in post-conflict Sierra Leone. The study will pilot mHealth-supported delivery of a culturally adapted version of the Family Strengthening Intervention for Early Childhood Development (FSI-ECD). The FSI-ECD has demonstrated effectiveness in improving parental emotion regulation and reducing family violence and harsh parenting practices among high-risk families with children aged 6-36 months in Rwanda. Study aims are to: Aim 1. Employ a five-phase user-centered design approach to develop and test mHealth tools to improve training, supervision, and fidelity monitoring of Community Health Workers. Study investigators hypothesize that mHealth tools will be feasible, acceptable, and user-friendly. Aim 2. Conduct a Randomized Controlled Pilot Study to assess feasibility, acceptability, and preliminary effects of the mHealth-supported delivery of FSI-ECD on parent mental health, emotion regulation, and familial violence in high risk families with children aged 6-36 months (n=40) in comparison to control families (n=40) who receive standard care. Parental mental health, emotion regulation, household violence, and parenting practices will be assessed at baseline, post-intervention and 6-month follow-up. The pilot study will also integrate a cost-effectiveness analysis to assess the economic value of the mHealth-supported delivery of the FSI-ECD vs. standard care. Study investigators hypothesize that (a) the effects of the FSI-ECD will be comparable to results observed with vulnerable families in Rwanda; (b) digital tools will be feasible and acceptable to CHWs and supervisors; and (c) mHealth-enhanced supervision and fidelity monitoring will increase supervisor engagement and support CHW quality improvement cycles. Aim 3. Leverage well-established relationships and government partners to strengthen capacity for mHealth research and quality healthcare delivery in Sierra Leone. Partners include the University of Makeni, the Directorate of Science, Technology and Innovation, and the Ministry of Health and Sanitation.

Start: December 2020

Drinking Water Chlorination and Child Survival in Rural Kenya

The purpose of the study is to estimate the effect of community-wide provision of water treatment (chlorine) solution on all-cause child mortality and on infectious disease related child mortality. We will also examine effects on the following secondary outcomes: 7-day diarrhea prevalence, all-cause under-2 mortality, diarrheal disease related child mortality, school attendance, and school enrollment. In addition, and for a subsample of children, we will examine effects on motor development, emergent language and literacy, emergent math/numeracy, and socio-emotional development.

Start: July 2019

Arabic Ages and Stages Questionnaire-III

Early detection and intervention for developmental delays are crucial in promoting healthy child development, hence the need for formal screening. In the Arabic speaking population developmental screening tools are scarce in the native language and there is a need for such a tool for pediatricians and health care workers to use routinely. This study aims to translate, adapt and validate the newest version of ASQ (ASQ-3) to Arabic (A-ASQ-3) based on the previously published study showing that ASQ-2 was culturally sensitive. The previously translated A-ASQ-2 will be revised and updated to match the new ASQ-3, then revised by experts in child development. Questionnaires will be adapted and field-tested on 15 subjects per age group (total of 75). For validity, the revised version will be tested on 500 Lebanese children (100 children per age group) selected from all Lebanese governates. It is expected to generate a culturally adapted and validated Arabic tool for screening children for any developmental delay up to 3 years of age. This tool once published will be available for use by primary care providers and caregivers in Arabic speaking countries. It may be used to screen children for developmental delay as early as 7 months therefore prompting prevention of further delay by starting early intervention and promoting child development.

Start: September 2015

Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months

From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations. The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated. This study, defined as a pilot study, proposes to evaluate the innovative "TrueGreen" BIO infant formula based on a new whey extraction method on the growth and tolerance of infants from 0 to 6 months compared to the conventional BIO infant formula. As no growth and tolerance data are currently available for this new TrueGreen BIO formula, this study aims to determine them.

Start: October 2018

Room to Grow Evaluation for Children

This research project is a small-scale randomized controlled trial (RCT) of an innovative program based in New York City called Room to Grow (RtG). Room to Grow's mission is to enrich the lives of babies born into poverty throughout their critical first three years of development. The research-informed program model combines tailored, one-on-one sessions with an expert clinical social worker in-person every three months plus ongoing communication (via phone and email), provision of essential baby items, and connections to vital community resources. The goal of Room to Grow's innovative program is to help parents increase the probability that their children will enter school ready to learn and continue on to meet their full potential in education, work, and citizenship. The therapeutic, psychodynamic approach and robust three-year long relationship with families is designed to act as the catalyst for sustainable, long-term change in parenting methods and family system stability. Critically, and in contrast to other programs aimed at improving parenting and child development, Room to Grow believes that providing concrete material assistance enhances the effectiveness of counseling and referrals to low-income families by reducing economic stress and freeing up scarce resources.

Start: January 2017

Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants

This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control formula. Approximately 450 infants will be enrolled from approximately 3 China sites. Of these infants, approximately 300 will be randomized 1:1 to receive an investigational formula or a control formula for 16weeks of feeding. The remaining approximately 150 infants will be enrolled as a breastfeeding reference group. The primary outcome measure is the rate of weight gain in g/day between baseline and 16 weeks in the test group compared to control formula group. Participants will have the option of providing stool samples at 8 weeks and 16 weeks for analysis of microbiota and metabolomics. The study period will be 16 weeks, and all infants in the 2 formula groups will receive formula free of charge for 6 months.

Start: July 2019

A Home Visiting Program for Pregnant Youth to Promote Early Brain Development II

Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to tools which will nurture and properly stimulate their baby, thus promoting emotional and cognitive development. Objectives: The "Nurse home visitation program for pregnant youth" aims to promote infant´s healthy development, from pregnancy to the first months of life, in a high-risk population. Methods: Eighty young pregnant women aged between 14 and 21 years were randomly allocated to the intervention or to usual prenatal care program. The "Nurse home visitation program for pregnant youth" was developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s bioecological model, which recognizes the importance of individual and family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of attachment, which involves the care practitioner addressing issues such as environmental health, life course and parenting, bond between mother and infant, and infant´s social and cognitive development. Neuropsychomotor development will be assessed at 3, 6, 12 and 24 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6, 12 and 24 months.

Start: June 2018

The Effect of Early-life Risk Factors on the Etiology of Diabetes in Children: a Birth Cohort

In recent years, with the rising prevalence of obesity among children, the incidence of type 2 diabetes in children and adolescents has continued to be increased. Some studies have found that impaired glucose metabolism appeared in 10-20% obese children. A large multicenter study project for children and adolescents showed that the prevalence of type 2 diabetes among children in the United States increased by 30.5% between 2001 and 2009. In addition, diabetes in children and adolescents, especially type 2 diabetes, has become more and more "younger". Diabetes appears in adolescence, which indicates that the damage of diabetes may come earlier, and it also has a significant impact on life quality and long-term survival. In recent years, more and more studies have shown that many adverse factors in the perinatal period would increase the risk of offspring suffering from metabolic diseases such as obesity and diabetes. Early life environmental factors would change the transcription and expression of obesity and diabetes-related genes through epigenetic regulation without changing the nucleotide sequence of the gene, then affecting the function of the gene and leading to diseases. Compared with the control group, pre-pregnant obese mothers and gestational diabetes mothers had higher DNA methylation levels in placenta leptin, which led to differences in the expression of leptin of offspring. A recent meta-analysis shows that the exposure to various social and environmental factors (diet, sleep, stress, bad habits, etc.) during pregnancy will affect the offspring. Due to the expression or methylation of CpG islands, these changes eventually lead to a variety of diseases including diabetes of offspring. However, most of previous researches mainly focused on the genetics or environmental factors. Meanwhile, most of the research focused on the Caucasian population. The differences between Asians and Westerners were few reported.

Start: June 2016

Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) and Its Effect on Infant Health in China

In the study, the composition and content of human milk oligosaccharides in premature delivery mothers in China will be examined to investigate the differences in oligosaccharide concentrations in preterm breast milk from different gestational weeks. This study will fill a gap in human milk research in China, provide theoretical basis for the superiority of breastfeeding, and provide more powerful nutritional support for the catch-up growth of preterm infants

Start: April 2019

Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational age (GA) improves BPD-free survival at 36 weeks post-menstrual age (PMA). Half of participants will receive docosahexaenoic acid (DHA), an omega-3 lipid, while the other half will receive a placebo.

Start: June 2015

Clinical Interventions to Mitigate Neurodevelopmental Risk

Family Nurture Intervention (FNI) has been shown to facilitate emotional connection and long-term child developmental progress in the NICU population. It has been theorized that FNI also promotes autonomic co-regulation and physiological synchrony between the mother-child dyad. The goal of the pilot study is to assess how a short one-time FNI session between at-risk mother and child dyads in the Well Baby Nursery (WBN) influences physiological synchrony, emotional connection, and developmental changes both short and long-term.

Start: February 2020

External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican NGO Un Kilo de Ayuda

Investing in early childhood development is one of the best cost-effective investments a country can make to boost long term economic growth, promote peaceful and sustainable societies, contribute to tackle poverty traps and eradicate inequality. It is also necessary to uphold the right of every child to survive and thrive. The single most powerful context for nurturing care is the immediate home, often mainly provided by mothers. Although the Mexican government has implemented social programs in the past, some with nutrition and child development components, poor and isolated communities have not benefited as others easier to reach. This is particularly true for the State of Oaxaca given its orography, where higher levels of malnutrition and a higher risk of suboptimal neurodevelopment are present. Since 1989, Un Kilo de Ayuda A.C. (UKA), a nongovernmental organization, has been involved in preventing child undernutrition in contexts of high poverty. Currently, UKA has 9 Early Childhood Development Centers distributed in 5 States of Mexico, including Oaxaca. UKA has developed the Neurological and Psycho-affective Early Childhood Development Program (NPECDP-UKA) that seeks to contribute to timely stimulation in children under 5 years of age and promote perceptual parenting practices. As part of the NPECDP-UKA, UKA redesigned their interventions to promote healthy nurturing care practices and responsive caregiving through workshops provided to caregivers and pregnant women, and with reinforcement through home visits. It is in the interest of this study to evaluate the NPECDP-UKA through a variation of a stepped wedge cluster randomized trial. The study sample consists of participants from 80 municipalities of Oaxaca (~50% with high or very high margination status), 20 municipalities were randomly assigned to each arm. Study arms differ by design on the time of exposure to the program (0,18,24 and 30 months at the final measurement). Subjects from all study groups share the characteristic to be enrolled in the NPECDP-UKA, the group with 0 months of exposure will serve as a comparison group. This distinctive characteristic of the study requires a progressive incorporation of study groups to be able to compare development measurements between study groups at the same ages and among subjects all enrolled in the program to avoid self-selection bias. The main study hypothesis states that children exposed to the Program will have better neurodevelopment outcomes than those not exposed. This study will provide evidence of the effect of an educational intervention for caregivers on the neurodevelopment of children under 5 years of age. Currently evidence of such interventions is very limited, especially for interventions performed by a nongovernmental organization. This is the first evaluation of this kind in Mexico.

Start: July 2019

Using a Cartoon Questionnaire to Improve Consent of Children

In this study, a prospective, multicenter, randomized, and controlled trial will be performed to evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving child understanding and enhancing a positive attitude to participate in biospecific nonspecimen specimen donation.

Start: November 2019