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Development, Infant clinical trials

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NCT ID: NCT05412524 Recruiting - Development, Infant Clinical Trials

Impact of Reading on Endogenous Oxytocin System of Preterm Infants

Start date: September 23, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to learn how early language exposure may be related to changes in DNA in parents and their premature infants. While a person's genetic code is determined at the time of conception, the way that some genes are expressed in the body can be changed even after an individual is born. These changes are called epigenetic changes. In this study, the investigators want to learn about the epigenetic changes that happen after a premature baby is born and whether a parent's interaction with their baby can influence these epigenetic changes. The investigators will look at epigenetic changes by collecting saliva samples from parents and their preterm babies, here defined as babies born at <33 weeks gestation. Specifically, the investigators will be looking at salivary levels of DNA methylation of the oxytocin receptor gene (OXTRm). The investigators will track changes in OXTRm levels over time in parents and their babies and see if these levels change in relation to how much time parents spend with their babies and how much time they spend reading to their babies. The investigators will ask mothers and, if desired, their partners to read to their babies for at least 15 minutes per week. The investigators will ask them to track time spent with the baby and reading time on a log, and will also measure word count with a commercially-available LENA device. The investigators will use logistic regression analysis to identify the independent association between OXTR DNA methylation and time spent with parent(s) and word count.

NCT ID: NCT05404815 Active, not recruiting - Preterm Birth Clinical Trials

Exposure to Plasticisers in the Neonatal Intensive Care Unit

PLASTIC-NICU
Start date: June 2, 2020
Phase:
Study type: Observational

Neonatal intensive care relies on indwelling plastic medical devices fundamental in respiratory support, intravenous catheterization, and nutrition. While being in a critical developmental period, constant exposure to these invasive medical devices puts premature neonates at risk of plasticizers' potential toxicity. Despite novel regulations and development of alternative plasticizers (AP), reference to guide manufacturers and an overview of the prevailing exposure levels to DEHP or alternatives in the neonatal intensive care unit (NICU) are still missing. The three main objectives of this project are: (1) to assess current exposure to plasticizers in the NICU, (2) to identify the sources of exposure and (3) to study the resultant long-term health risk in premature neonates. These objectives are addressed in three work packages (WP). In work package 1, in vivo exposure of premature neonates to phthalates and alternative plasticizers is assessed by determining their metabolites in biological matrices (urine and hair). Work package 2 explores ex vivo leaching characteristics of different plasticizers from medical devices used in the NICU. Finally, Work package 3 studies the long-term neurocognitive and lung development in relation to plasticizer exposure in the NICU.

NCT ID: NCT05261503 Completed - Preterm Clinical Trials

Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effectiveness the HEP (Homeostasis-Enrichment-Plasticity) approach, which based upon the principles of enriched environment (EE) and ecological theories of development on preterm infants with developmental delay risk. Thirty-two preterm infants aged 4-10 months will be randomly divided into 2 groups as the HEP intervention group and the Traditional Physical Therapy (TPT) group. EE-based intervention will be applied to the HEP intervention group, and traditional physiotherapy will be applied to the TPT group for 12 weeks (24 sessions). The demographic information of the participants will be recorded. The motor and sensory functions of the infants will be evaluated with, the Peabody Developmental Motor Scales (PDMS-2) and the Test of Sensory Functions in Infants™ (TSFI™), respectively. Additionally, the anxiety status of the parents will be evaluated with the Beck Anxiety Inventory (BAI). All evaluations will be done twice, at the end and at the beginning of 12 weeks.

NCT ID: NCT05230199 Recruiting - Clinical trials for Parent-Child Relations

Sensory Optimization of the Hospital Environment

SOOTHE
Start date: May 29, 2023
Phase: N/A
Study type: Interventional

The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.

NCT ID: NCT05147480 Completed - Anxiety Clinical Trials

Online Mother-Baby Yoga With Preterm Infants and Their Mothers

Start date: January 7, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effects of internet-based mother-baby yoga on preterm infants and their mothers.

NCT ID: NCT05004597 Completed - Development, Infant Clinical Trials

3D Craniofacial Morphologic Development of Healthy Infants

Start date: December 4, 2018
Phase: N/A
Study type: Interventional

Healthy infants were enrolled to receive three dimensional craniofacial photography regularly at their age of one month, two month, four month, six month, nine month and twelve month. All the image data was analyzed to reveal infants' craniofacial development.

NCT ID: NCT04693494 Completed - Healthy Clinical Trials

Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. The purpose of this study is to know if motor development can be improved by the environment.

NCT ID: NCT04689386 Recruiting - Clinical trials for Respiratory Distress Syndrome in Premature Infant

Effect of Chest Physiotherapy on the Development of Preterm Infants.

Start date: February 26, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of the stimulation of "reflex rolling" from the Vojta method and the effect of the expiratory flow increase technique on the development of the preterm infants. In the same way, it will be assessed whether the application of these techniques produce pain. This application will be carried out in preterm infants of less than 32 weeks of gestation with neonatal respiratory distress syndrome (SDR) and carriers of mechanical ventilation. The intervention will take place in the neonatal intensive care unit (NICU) The intervention period is one month (4 weeks) and different follow-ups will be carried out at term age, at 3, 6, 9 and 12 months of corrected age.

NCT ID: NCT04506541 Completed - Clinical trials for Breastfeeding, Exclusive

The Effects Of KC On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Kangaroo care is a developmental care method determined to improve the quality of life of premature babies. When the benefits of kangaroo care on development and feeding with breast milk on premature babies are considered, term babies should also receive kangaroo care, and kangaroo care should be started immediately after birth. In this research, the authors aimed to investigate the effect of kangaroo care at birth on breast milk only feeding status and infant growth and development according to attachment theory. This is a randomized controlled, experimental, prospective study. The sample of the study consisted of pregnant women between 36-38 gestational weeks, who referred to the pregnant outpatient clinic of Buca Maternity and Children Hospital between March 2017 and February 2019 (n: 132). Pregnant women in the intervention group received "kangaroo care and breastfeeding training," and their babies were given kangaroo care at birth. Routine care was given to the mothers and their babies in the control group. Maternal attachment levels of mothers in both groups after birth and infants' breastfeeding only status and infant growth and development in the first, third, sixth, and ninth months were evaluated.

NCT ID: NCT04436055 Terminated - Drug Use Clinical Trials

Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)

EPIC
Start date: October 26, 2020
Phase:
Study type: Observational

The overall objective of this proposed project is to prospectively evaluate the epigenetic and developmental effects of paternal cannabis and other drug use in offspring.