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NCT06195358
Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority. Supporting caregivers to provide nurturing care is an evidence-based strategy, however feasibility of scaling-up this supporting is limited by competing demands on health workers' time. For infant development, mHealth technologies have the potential to solve this problem by providing tailored content directly to caregivers, involving and empowering them to promote infant development, promoting and facilitating interactions with health workers when areas of concern are identified and, therefore, expanding the reach of healthcare systems. Following a pilot feasibility study, this current study will examine the effectiveness of a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala and support early childhood development.
NCT07418528
The goal of this observational study is to analyze early development in infants and young children from a biopsychosocial perspective, with a particular focus on cognitive, language, motor, social-emotional, and adaptive functioning during the first years of life. The study will include infants and young children from 16 days of age up to 42 months of age, assessed during a single diagnostic session conducted by qualified specialists. The developmental assessment will include standardized diagnostic tasks and direct observation of behavior in the form of play and natural interaction, carried out in the presence of a parent or legal guardian. In addition, information regarding the child's everyday functioning will be collected from parents or caregivers using standardized questionnaires, including data on social-emotional competencies, communication, and adaptive skills. The main research questions addressed by this study are: What is the developmental profile of infants and young children in the first years of life? What relationships exist between different domains of early development within a biopsychosocial model of child functioning? Can specific developmental patterns be identified that indicate an increased risk of developmental difficulties in early childhood? How does age differentiate the structure and variability of developmental functioning across assessed domains? The study is non-invasive and observational in nature. Data will be analyzed exclusively in aggregated form and will contribute to a better understanding of early child development as well as to the development of norms and tools supporting early diagnosis and developmental intervention.
NCT06335524
This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.
NCT05868408
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
NCT06059209
This study will compare infant gut bacteria for infants who have been fed a standard infant formula (Enfamil Infant); infants who have been fed a new infant formula designed to be more similar to breast milk (Enfamil NeuroPro); and breastfed infants. These formulas are currently available on the market and meet FDA requirements for infant formula.
NCT06018064
The goal of this clinical trial is to learn about the use of the Prone Positioner in pediatric patients with tracheostomies (trachs). The main question\[s\] it aims to answer are: * What is the fit and satisfaction of the device? * Does the device fulfill the goal of allowing infants with trachs participate in tummy time * What aesthetic feedback will the study team receive on the prone positioner from families, therapists, and nursing staff. Participants will be placed in the Prone Positioner, they will be monitored for their comfort/satisfaction with use, and how well they are able to be receive ventilation while in the device. Parents of these infants, as well as healthcare providers, will be surveyed on thoughts/suggestions for the Prone Positioner.
NCT06593236
The goal of this study is to better understand the use of the Huckleberry app, a pediatric sleep guidance app and the impacts on infant sleep and maternal mental health.
NCT06312358
The goal of the research study is to increase teachers' implementation of evidence-based practices in Early Head Start classrooms through the delivery of a professional development (PD) training intervention. The main questions that the study aims to answer are: 1. Does teacher participation in a PD intervention improve the use of evidence-based practices from pre- to posttest? 2. To what extent is the PD intervention feasible to implement in an established child care program? 3. To what extent is the PD program acceptable to teachers? Participants will attend PD workshops and participate in content-related job-embedded coaching sessions during the implementation of the study.
NCT06479278
The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is: Will the TWMB program increase the time a caregiver talks to their infant? Participants will: 1. Come to at least four well-child checkups 2. Receive the TWMB program from the provider during the checkups 3. Record their conversations with their infant before they receive the program and after they receive the program four times.
NCT07081698
The objective is to investigate the effect of walnuts on gut microbiota, inflammatory markers, atopic dermatitis status, and indices of allergy outcomes in breastfed infants during early complementary feeding. The three primary aims include: Aim 1: Evaluate the effect of walnut consumption on gut microbiota structure and function, inflammation, atopic dermatitis, and allergy outcomes. Aim 2: Evaluate the impact of walnut consumption on infant growth trajectories and risk of overweight. Aim 3 (exploratory): Identify walnut-specific food signatures that are associated with gut microbiota and immunity biomarkers using a novel nutri-metabolomics technique.
NCT04749888
Maternal and early childhood home visits have been proposed as an effective strategy to improve the health and development of disadvantaged children. In South Korea (hereafter, Korea), a maternal and early childhood home visit program has been implemented since 2013 in Seoul, and then was adopted in 2019 by the central government as a national policy for child health and development. The Korea Early Childhood Home-visiting Intervention (KECHI) encompasses 25-29 home visits, group activities, and community service linkage by social workers from the prenatal period until the child reaches the age of 2 years; as such, it is a complex intervention involving various domains to address a wide range of outcomes. Each home visit is implemented based on the family's needs, and individualized interventions are provided to improve parenting and the home environment in order to promote children's health and development and maternal health. This study is a randomized controlled community trial conducted in Korea to examine the impact of targeted home visits led by nurses in the prenatal and early childhood period on children's health and development and maternal health. This study is a superiority trial with two parallel groups from pregnancy until the child reaches 2 years of age. Pregnant women with two or more risk factors will be recruited to participate in the study after they provide informed consent. Participants will then be randomly assigned to the intervention or control group with a 1:1 allocation through an independent web-based random allocation system. We expect a total of 800 families (400 families in each group) to be recruited. The intervention group will receive the KECHI program and the control group will receive existing maternal and child health services (usual care), but not multiple home visits by nurses. Both groups will receive gift cards of 30,000 Korean won (about 27 USD) for each round of surveys. The intervention and control groups will be surveyed on the outcome variables of home environment, child development, breastfeeding, maternal health, child hospital visits due to injuries, and community service linkage at four home visits by trained research nurses at baseline and at 6 months, 12 months, and 24 months after birth. Telephone contact will also be made at 6 weeks and 18 months after birth for both groups. Outcome measurements will be performed by research nurses and data management will be conducted by statistical analysts. The analysis will be conducted for the intention-to-treat (ITT) and per-protocol (PP) groups, with an interim analysis of outcomes up to the 6-month follow-up. For the primary outcomes and certain secondary outcomes, subgroup analyses will be performed based on factors such as region, fertility status, number of risk factors, presence of depression, education level, etc. Furthermore, this study will utilize administrative data available for all study participants to evaluate both short and long-term impacts of the KECHI intervention on maternal and child outcomes.
NCT06107933
The goal of this observational study is to characterize and evaluate micro- and nano-plastic (MNP) exposures among mothers and infants in mother-infant dyads 1 or 3 months postpartum living in Baltimore, Maryland. The main questions it aims to answer are: * What MNPs are present in breastmilk and maternal blood samples and in their infants stool sample? * Are there associations between amount of maternal MNPs in breast milk and mass of MNP particles in infant stool? * Which environmental and lifestyle factors are most predictive of maternal MNP burden? * Is infant exposure to MNPs associated with birth weight and postnatal growth trajectories? Participants will: * Complete several questionnaires assessing medical histories, lifestyle factors, environmental exposures, eating behaviors, etc. * Provide biological specimens including: maternal blood, stool, and breastmilk; infant stool * Clinical visit to have anthropometric measures documented including maternal height and weight, infant weight, length, and skin-fold thickness
NCT05049655
An observational study to generate a long-term outcome database from medical records for infants who completed protocol SS-101-18 or infants who are breastfed, fed commercial formula, or fed a marketed ByHeart formula.
NCT06436404
This study was planned to evaluate the effectiveness of two positions that may have an effect on pain, stress, comfort and physiological parameters in premature infants.
NCT04267302
The goal of this study is to experimentally test whether baby items can promote healthy infant development.
NCT02069782
MIHOPE is a multi-state study of home visiting programs authorized under the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program. The study is required by the federal Patient Protection and Affordable Care Act of 2010 (ACA), which created the MIECHV program. It is being conducted by MDRC under contract to the Administration for Children and Families within the US Department of Health and Human Services. In conducting the research, MDRC has subcontracted portions of the research to Mathematica Policy Research, Johns Hopkins University, Columbia University, University of Georgia, and James Bell Associates. MIHOPE is randomly assigned 4,229 families nationally to home visiting services or to a comparison group that will receive referrals to other services in the community. The study is seeking to include 88 local home visiting programs (sites) that are funded through MIECHV in approximately 12 states. Data will be collected from families, local home visiting programs, and state and federal administrative data systems to assess the effects of the programs on family outcomes and to learn more about how the programs are run. Sites included in the evaluation will be using one of four national service models (Nurse Family Partnership, Healthy Families America, Parents as Teachers, and Early Head Start-Home Visiting Option) that states have chosen for most of their MIECHV funding. MIHOPE will inform the federal government about the effectiveness of the MIECHV program in its first few years of operation, and it will provide information to help states develop and strengthen home visiting programs in the future. Research findings will be disseminated through a report to Congress in 2015; reports on program impacts, implementation, and on the relationship between program features and program impacts; journal articles; and practitioner briefs.
NCT05923333
The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on: * gut microbiome composition and diversity at 4 weeks of life * markers of intestinal inflammation and microbial translocation at 4 weeks of life * Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life The secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on: * longitudinal succession of the gut microbiota composition, diversity and function * relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life * stool metabolome * T cell subset ontogeny during the first 9 months of life. Exploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves: * infant growth * all-cause morbidity * neurodevelopment during the first 9 months of life * antibody responses to early childhood vaccines
NCT05259059
The first 1000 days, i.e., the earliest stage of life, is a unique period of opportunity to establish the foundations of human growth and health through the lifespan. In the recent decades, multiple studies have explored nutritional strategies for improving infant health through improving the nutritive and bioactive compositions in breast milk. For example, dietary fiber intake has been increasingly reported to benefit the health of the mother-infant dyad. However, the complex interplays among maternal diet, breast milk composition, infant gut microbiota and infant development are yet to be elucidated in a prospective cohort. In addition, the investigators' previous work has revealed unsatisfactory dietary patterns in Hong Kong lactating women, with clear inadequacy in fruit and vegetable intake. In this prospective cohort study, the investigators aim to recruit 100 healthy Chinese mother-child pairs. Data on maternal and infant dietary intake, breast milk composition, gut microbiota profile will be collected and the investigators will examine their associations with the health outcomes in infants. In addition, the influence of dietary factors and genetic predisposition on breast milk components and its associated benefits in the child will be interrogated. With the employment of multidisciplinary research approaches, cutting-edge biotechnologies and the omics platforms, this project will provide novel insights into the dietary factors and breastfeeding practices that are beneficial to the infant developmental trajectory, and the potential roles of breast milk composition in shaping infant's gut microbiota and the associated health impact in the long term. More importantly, the investigators hope to generate more solid scientific data to inform the public of the importance of maternal diet and the practical nutritional strategies to improve breast milk composition for the sake of the child.
NCT06531330
High risk of infant is defined as an infant who has a history of negative environmental and biological factors and these factors can cause neuromotor development problems. This group is a heterogeneous group that includes premature babies born under thirty-seven weeks, term babies with low birth weight (LBW), or babies with developmental delays for various reasons. These infants are also monitored for Cerebral Palsy (CP). CP is the most common physical disability in childhood, with an incidence of 2.1 per 1000 births.In a 2017 clinical review of early diagnosis tools, a group of international experts published best practice recommendations, calling for early diagnosis to be made as a result of timely use of the recommended tools. The diagnosis of CP is typically made by a physician between 12 and 24 months of age, but in some cases it is delayed until 42 months.Correct and early use of the key tools required for early diagnosis may allow much earlier detection of CP for infants younger than 5 months or older.Early detection and monitoring of infants in the community for CP is essential only with appropriate, valid and reliable tools in order to minimize possible sequelae through timely implementation of CP-specific interventions. According to international guidelines, babies with high risk of CP should be followed up. This follow-up should be done by an interdisciplinary team such as neonatologist, pediatrician, pediatric neurologist, physiotherapist, speech-language-swallowing therapist, and special education specialist. Pediatric physiotherapists are an important part of this team in terms of developmental follow-up and rehabilitation. Therefore, it is important that the awareness level of pediatric physiotherapists in this field in our country is sufficient, they are equipped with various trainings and reach the international level. In this way, families at risk of CP can provide early guidance for their children, ensure early diagnosis of CP, and initiate treatment.The aim of this study is to evaluate the use of early diagnostic evaluation tools in at-risk of infants between the ages of 0-2 at risk of CP in pediatric physiotherapy practice in Turkey.
NCT03297801
Prenatal supplementation with fish oil, rich in omega-3 polyunsaturated fatty acids, is widely recommended in Canada. The aim of this observational, prospective cohort study is to determine the effects of maternal fish oil supplements on the development of their infants' gut microbiota and immunity.