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Infant Development clinical trials

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NCT ID: NCT06363019 Recruiting - Anxiety Clinical Trials

Supporting At-Risk Mothers Across Perinatal Period

SMART
Start date: February 26, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06361134 Completed - Infant Development Clinical Trials

Efficacy of Supporting SAFE Early Intervention

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention.

NCT ID: NCT06352229 Recruiting - Clinical trials for Parent-Child Relations

The Playful Learning in Infancy Program

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

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.

NCT ID: NCT06335524 Not yet recruiting - Child Development Clinical Trials

Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

IMPACT
Start date: September 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06332521 Recruiting - Infant Development Clinical Trials

Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment

BABYCRY_1000
Start date: March 20, 2024
Phase:
Study type: Observational

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.

NCT ID: NCT06312358 Not yet recruiting - Child Development Clinical Trials

Expanding the Infant Achievements Intervention Through Community Partnerships

Start date: March 2024
Phase: N/A
Study type: Interventional

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.

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.