View clinical trials related to Infant Development.
Filter by:The SMART app is a mobile application based psychosocial parenting intervention containing educational materials (articles, videos, audios, podcasts) on parenting, an integrated peer support chat function with experienced mothers and an integrated forum for interaction with other mother participants. The goal of this interventional study is to test the effectiveness of a mobile-app health based intervention, SMART, mothers in the perinatal period. The main questions this study aims to answer are: 1. What is the effect of a mobile-based health intervention, SMART, on maternal outcomes? 2. What is the effect of a mobile-based health intervention, SMART, on infant outcomes? 3. What is the cost-effectiveness of using SMART as compared to standard routine care? Researchers will compare results with a control group that will undergo standard routine care.
In the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for interactive engagement. The guidance is delivered to parents during routine home visits by public health visitors. The aims of the Playful Learning in Infancy Program are to 1) promote playful interactions between infants and parents, parental attitudes towards play, and infant socioemotional development; 2) enhance the language and knowledge of playful learning in infancy among frontline staff; and 3) evaluate the Playful Learning in Infancy Program for potential testing in a future large-scale RCT study. Evaluation is based on a parallel group study design, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program.
Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords. Crying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry.
The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity. The study team plans to recruit 100 healthy, term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants.
More than 60,000 infants are born between 22 to 32 weeks gestation age annually in the US. Approximately 11% of them develop comorbidities. During NICU hospitalization, preterm infants inevitably endure early life toxic stress without adequate protective buffers. Early life toxic stress results in adverse epigenetic modifications of glucocorticoid-related genes and dysbiosis, impairing neurodevelopment. These adversities further exacerbate the risk of comorbidities and inappropriate brain development during sensitive periods of neuroplasticity. Adverse epigenetic modifications and dysbiosis may set a life-long trajectory of risk for chronic health conditions. It is a clinical and scientific priority to test an early NICU intervention to attenuate stress-related adverse epigenetic modifications and dysbiosis. Human milk influences the structure and relative abundance of healthy gut bacteria and neurodevelopment. Maternal nurturing, e.g., licking and grooming (in rodents), and breastfeeding and touch (in humans), promotes neurodevelopment, reduces stress, and reverses stress-related epigenetic modifications. The multisensory early oral administration of human milk (M-MILK) intervention is designed to provide an enjoyable and nurturing experience for infants, through a safe and consistent infant-guided provision of human milk droplets, given orally as early as 22 weeks postmenstrual age. M-MILK is implemented from day 3 of life, after every hands-on care, and during the beginning of a full gavage feeding. We propose the M-MILK pilot randomized controlled trial (RCT): a 2-group (N = 12, 6 per group), parallel, and longitudinal design in preterm infants who are born between 22 to 28 weeks gestational age. The aims of this pilot are to determine the feasibility and acceptability of the M-MILK intervention, recruitment, retention, and obtain data for sample size estimation. This study will advance nursing science and practice because it will inform our R01 RCT to examine the efficacy of M-MILK to attenuate adverse effects of early life toxic stress in preterm infants.
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.
The study will be conducted at various city swimming pools in Warsaw. The study participants will include 20 infants participating in aquatic baby classes once a week and 20 infants not participating in any classes and their parents. The study will be conducted in a quiet and calm room, which will be prepared in advance and equipped with a smooth mat, a lounger and infant toys. The estimated time to conduct the study is about 30 minutes. The examination will be carried out twice: before the start of the two-month course and after its completion. Each time in the presence of a parent or legal guardian, after signing a consent form for the study. The selected methods of assessing motor development are fully non-invasive and consist of the following tests: 1. Alberta Infant Motor Scale (AIMS)-a test involving observation of motor development, in which each activity is assessed as existing or not. The sum of the scores from all trials is then placed on a centile grid, the results of which will indicate how many children of a certain age are achieving a given level of motor skills. 2. Early Motor Development Questionnaire (EMQ)-will be conducted on the basis of a ready-made form and in an anonymous manner based on parents' current knowledge of their children's development.
The purpose of the study is to understand how mothers think and feel about feeding their babies and putting them to sleep, understand more about programs that can support mothers taking care of babies, and how professionals can be most helpful in helping mothers make decisions about their baby's feeding and sleeping. The overarching goal is to prevent early life obesity and progression to metabolic syndrome in high-risk populations, starting with healthy toddler weights by age 2 years.
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 one-month postpartum living in Denver and Boulder, Colorado. 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
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.