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Infant Development clinical trials

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NCT ID: NCT05132374 Completed - Child Development Clinical Trials

The Infant- Toddler Climate of Healthy Interactions for Learning and Development (I-T CHILD)

I-T CHILD
Start date: December 7, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to train New York-based early childhood mental health consultants (ECMHCs) who will apply the Infant-Toddler Climate of Healthy Interactions for Learning and Development (I-T CHILD) tool as part of their standard practice. The study will evaluate I-T CHILD-informed early childhood mental health consultation in 100 New York State-licensed family day care and group family day care programs serving infants and toddlers in lower-income neighborhoods

NCT ID: NCT05106894 Active, not recruiting - Infant Development Clinical Trials

Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Start date: January 11, 2023
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. This overall study is designed to explore this idea, by designing a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala in providing nurturing care and, after design, to conduct a prospective implementation trial of its use followed by an adequately-powered efficacy study.

NCT ID: NCT05101707 Completed - Hemiplegia Clinical Trials

CIMT and taVNS for Hemiplegia in Infants

Start date: April 1, 2022
Phase: Early Phase 1
Study type: Interventional

Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body. In older children, therapists may use a hand mitt and restraint for the stronger arm, to encourage use of the weaker side, called constraint-induced movement therapy (CIMT). Even with the high intensity therapy of CIMT, it typically takes between 40-120 hours total treatment time for most children to improve their motor skills. A non-invasive form of nerve stimulation, transcutaneous auricular vagus nerve stimulation (taVNS), stimulates a nerve by the ear that enhances learning motor skills. The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with CIMT in infants with one-sided weakness at 6-18months of age.

NCT ID: NCT05049655 Enrolling by invitation - Infant Development Clinical Trials

Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers

Start date: October 19, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT05039918 Not yet recruiting - Pain Clinical Trials

Neonatal Experience of Social Touch

NEST
Start date: September 2021
Phase: N/A
Study type: Interventional

The purpose of this randomised control trial is to determine the efficacy of CT-optimal touch (gentle stroking at 3cm/s) for newborn's who require a heel prick.

NCT ID: NCT05011825 Completed - Depression Clinical Trials

A Pilot Evaluation of the Pregnant Moms' Empowerment Program

Start date: March 15, 2017
Phase: N/A
Study type: Interventional

This project will use a longitudinal design with assessments at baseline (T1), post-treatment (T2), 3 month post-partum (T3), 1 year postpartum (T4) and 3.5-5 years postpartum to examine whether the PMEP improves participants': a) mental health (depression, PTSD) and resilience, b) parenting skills, c) birth, infant, and toddler developmental outcomes, and d) lowers re-victimization rates. We hypothesize significantly improved outcomes in the intervention group compared to the control group at post-treatment and at all follow-ups. The pilot will use a quasi-randomized design, with participants assigned to alternating treatment and control blocks. Analyses will be conducted using intent to treat and per protocol methods. Following group assignment, all women will be scheduled for a baseline interview at a time convenient for the participant. Participant interviews will take approximately 1.5 hours. Mothers will be compensated with a gift card in the amount of 40 USD for each interview. In addition to the core evaluation metrics, mothers' demographic information will be obtained (age, relationship status, employment, education, number of children, income). Following the baseline interview, the PMEP will be provided to the treatment group; participants will receive 2-hours of contact time per week for 5 weeks (2-hour sessions, held once weekly). Women will receive reminder calls the day of each session to identify and resolve any barriers to attendance (e.g., transportation). Taxi fare will be supported for women who are unable to obtain transportation if the bus is not feasible. Following the completion of the PMEP groups or - for the control group - after 5-6 weeks has passed, all participants will complete a second interview. This interview will include all of the core measures of hypothesized treatment change, thereby permitting a comparison between women in the treatment and control groups over time. All women will be invited in a third time when their infant is 3 months old and again when their infant is 1 year of age to evaluate parenting and infant outcomes. Women will participate in a brief phone assessment when their children are between 3.5 and 5 years of age that includes all primary study outcomes.

NCT ID: NCT05006989 Recruiting - Infant Development Clinical Trials

Blueberry Intake and Infant Gut Health

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The objective of this project is to investigate the effects of blueberries on gut microbiota, inflammation and innate immunity in breastfed infants during early complementary feeding (~5 to 12 months of age).

NCT ID: NCT04987593 Completed - Infant Development Clinical Trials

Characterisation of the Gut Microbiota in Term Infants After Maternal Supplementation of Probiotics

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

A monocenter, open label pilot study in pregnant women and their offspring with at least four weeks prenatal and four weeks postnatal maternal intervention with a study product consisting of four different food constituents. The study will investigate the effect of maternal supplementation with the food constituents on the recovery of the constituents in the maternal and infant feces, the microbiota in both mother and infant and potential transmission routes from mother to infant.

NCT ID: NCT04901611 Completed - Infant Development Clinical Trials

Parental Touch Trial (Petal)

Petal
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

This is a two centre two-arm randomised controlled interventional trial. We aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia in neonates.

NCT ID: NCT04854226 Recruiting - Infant Development Clinical Trials

Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Macronutrient Composition to Improve Growth

Start date: April 21, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to measure protein turnover rates in preterm infants.