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Development, Infant clinical trials

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NCT ID: NCT04301453 Completed - Development, Infant Clinical Trials

The Effect of Maternal Scent on Sleep Wake States

Start date: October 30, 2019
Phase: N/A
Study type: Interventional

This study will be a prospective, randomized controlled study, which aims to determine if a maternal scent intervention improves the sleep wake states, brain maturation, and heart rate variability in premature infants admitted to the neonatal intensive care unit (NICU). Infants will be randomized to either 24 hours of exposure to maternal scent or standard of care. Sleep wake states will be obtained using behavioral coding. Brain maturation will be measured using several electroencephalogram (EEG) parameters. Heart rate variability will be collected as part of vital sign collection.

NCT ID: NCT04203589 Completed - Cerebral Palsy Clinical Trials

Explorer Babies Early Intervention Program

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Premature babies have a high risk of adverse developmental outcomes. Early intervention approaches are applied to reduce these adverse outcomes or support of developmental delay. Early intervention approaches may vary depending on developmental priorities. While some early intervention methods can consider body structured findings such as posture, tonus, muscle power, others may consider coaching family, enrichment of the environment. The explorer baby program is developed based on the trial and error process. The program tries to find an answer to a unique question: "how trial behavior in infants can be increased and which behaviors of the infants should be supported to increase their trial process?" The Explorer baby program tries to increase exploratory motor behaviors to facilitate development. For this aim, the program tries to explain how a baby learns new skills such as rolling, sitting, babbling, playing peek a boo, etc. in all domains of development while the baby lives in their natural environment. This study aims to investigate the effect of the explorer baby early intervention program.

NCT ID: NCT03967743 Recruiting - Genetic Disease Clinical Trials

Application of a Systematic Developmental Assessment to a Novel Population: Infants With Rare Genetic Disorders

Start date: August 26, 2019
Phase:
Study type: Observational [Patient Registry]

The main objective of this study is to apply a well-established model of developmental surveillance (which evolved to characterize the outcomes of very low birth weight infants) to infants with genetic disorders. A novel clinical model for infants with rare genetic disorders has been created as a joint initiative between the Division of Newborn Medicine's NICU Growth and Developmental Support Programs (NICU GraDS) program and the Division of Genetics at Boston Children's Hospital (BCH). This study plans to enroll patients with genetic syndromes seen in this clinic into a prospective, longitudinal study in order to characterize their developmental profiles and needs.

NCT ID: NCT03849248 Recruiting - Development, Child Clinical Trials

Maternal Scent and Preterm Infant Nutrition

Start date: May 24, 2019
Phase: N/A
Study type: Interventional

To study the effect of maternal scent on the oral feeding, behavior and stress level of premature infants hospitalized in the Neonatal intensive care unit and to assess its potential effect on their development at 18 to 24 months.

NCT ID: NCT03506971 Active, not recruiting - Development, Infant Clinical Trials

Early Childhood : Action Research in the Lunévillois Area (PERL)

PERL
Start date: September 10, 2018
Phase: N/A
Study type: Interventional

The PERL project is a research in prevention in perinatality. The objective of this research is to offer preventive and regular care at familie's home in the Lunévillois area, while integrating it into the existing practices of the maternal and child protection, in the framework of a partnership between the PMI (Protection Maternal Infantile) and the child psychiatry. An innovative prevention device to support the interactions and development of the child will be proposed to about sixty families, randomly recruited into the general population. If the family agrees to participate, their will benefit from regular home visits by a pediatric nurse, accompanied on certain times by a psychologist, for a period of 4 years from the birth of the child. This home-visits accompaniment, centered on listening and observation, focuses on three areas: baby's development, parenthood and parent-child's interactions. A longitudinal and comparative evaluation will be carried out with a "control" group recruited according to the same conditions and at the same time as the "participants" group. A parallel research on the processes and mechanism will be carried out in partnership with the School of Public Health in order to define and validate the intervention theory (what are the mobilized levers produced and how, what are the mechanisms linking the intervention to its results), to describe the implementation and the processes involved, and to analyze the effects of context, especially social, on processes and results.

NCT ID: NCT03306316 Completed - Nutrition Clinical Trials

Prebiotic in Preterm Infants

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

This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18 months. The investigators anticipate collecting clinical data, anthropometrics, stool samples (requiring appropriate storage through analysis), salivary samples from mother and infant, discarded blood samples from baby after the standard care lab tests are done, a single, optional blood draw at the conclusion of the study, and subjecting infants to a neurodevelopmental survey at study completion. The overall goal of this study is to test prebiotic administration to human milk-fed infants who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through one primary aim, a secondary aim, and exploratory aims, indicated below: Primary aim: Compare weight, length, and head circumference Z-score growth between the study and placebo groups. Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more) between the study and placebo groups. Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups. Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of supplementation on reducing intestinal inflammation between the study and placebo groups. Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to determine whether there is a shift in microbial composition towards bifidobacteria and other microbes that are capable of metabolizing prebiotic.