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Infant Development clinical trials

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NCT ID: NCT06278961 Recruiting - Cerebral Palsy Clinical Trials

Families Filming Infants Learning Movement

FILM
Start date: January 28, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT06230848 Recruiting - Stress Clinical Trials

Multisensory Early Oral Administration of Human Milk in Preterm Infants

M-MILK
Start date: October 23, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06195358 Recruiting - Infant Development Clinical Trials

Mobile Health Intervention for Infants in Guatemala (18-m Intervention)

Start date: January 25, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06191757 Completed - Infant Development Clinical Trials

Effect Of Early Intervention Program Applied To Premature Infants

Start date: November 28, 2021
Phase: N/A
Study type: Interventional

Purpose: This study was conducted to evaluate the effect of singing a lullaby with compassionate touch on early comfort and later on development of developmental support program in premature infants in the neonatal intensive care unit. H01: Singing a lullaby along with touching in the early stages of premature babies in the neonatal intensive care unit has no effect on the comfort score of the babies. H02: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the social emotional skills of premature babies. H03: Singing lullabies with touch to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the language skills of premature babies. H04: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the cognitive skills of premature babies. H05: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the motor skills of premature babies.

NCT ID: NCT06180330 Completed - Infant Development Clinical Trials

The Impact of Water Activities on Motor Development in Infants

Start date: December 15, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06144450 Not yet recruiting - Infant Development Clinical Trials

Evaluation of Effectiveness of the Web-Based Monitoring Program Given to Mothers of Premature Babies

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

The study was planned to determine the effect of the web-based hospital and home follow-up program given to mothers of premature infants on infant growth-development, repeated hospitalization of the infant, maternal stress, preparation for discharge, home care and problem-solving care skills.

NCT ID: NCT06117631 Recruiting - Metabolic Syndrome Clinical Trials

Project Sueño: Sleep & Understanding Early Nutrition in Obesity

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06107933 Recruiting - Infant Development Clinical Trials

Developmental Impacts of Microplastics Exposure in Early Life

DIMPLE
Start date: October 1, 2023
Phase:
Study type: Observational

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

NCT ID: NCT06059209 Recruiting - Infant Development Clinical Trials

Enfamil NeuroPro Study

Start date: January 5, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06053515 Recruiting - Pregnancy Clinical Trials

Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication

Start date: October 9, 2023
Phase: N/A
Study type: Interventional

Rosie the Chatbot is an educational chatbot that moms can have on their computers or cellphones and will work by moms typing in their questions about pregnancy, health, infant milestones, and other variety of health related topics and receiving back a response immediately. Rosie only provides information from verified sources such as children's hospitals, health organizations and government agencies. Rosie does not ask moms to provide any personal information on her or her child, her chat is completely confidential, it works in English and Spanish and will be free.