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Infant Development clinical trials

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NCT ID: NCT04347590 Recruiting - Infant Development Clinical Trials

Continuous Glucose Monitoring and Cerebral Oxygenation in Preterm Infants

Glucolight
Start date: April 24, 2020
Phase: N/A
Study type: Interventional

Neonatal hypoglicaemia is associated with impaired neurodevelopment outcomes in preterm infants. Thus, hypoglicemic events should be diagnosed and treated promptly. Unfortunately, hypo- and hyperglicaemia management is still controversial. The investigators aim to assess if a continuous glucose monitor (CGM) impacts on both short-term and long-term neurodevelopment. Primary outcome is the effect of CGM coupled with a control algorithm for glucose infusion on the number of hemodynamic significant events (defined as hypoglycemic events associated with DOT-detectable reduction of brain oxygenation). It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, they will be randomized in two study arms, both of them will wear Medtronic CGM during the first 5 days of life: 1) Blinded group (B): the device monitor will be switched off, glucose infusion rate will be modified according to the daily capillary glucose tests. 2) Unblinded group (UB): the device monitor will be visibile, alarms for hypos/hyper will be active and glucose infusion rate will be modulated according to CGM and PID control algorithm. Enrolled newborns will also be monitored with near-infrared diffuse optical tomography (DOT) during the first 5 days from enrollment. Follow-up will be performed at 12, 18, 24 months and 5 years by neurodevleopmental scale (Bailey III until 24 months; Wechsler Preschool and Primary Scale of Intelligence (WPPSI) at 5 years). The estimated numerosity is 60 patients (30 for each arm).

NCT ID: NCT04321200 Recruiting - Pediatric ALL Clinical Trials

PANDA Gym: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability

Start date: November 1, 2020
Phase:
Study type: Observational

Early childhood detection of motor delays or impairments provides the opportunity for early treatment which improves health outcomes. This study will use state of the art sensors combined with machine learning algorithms to develop objective, accurate, easy-to-use tools for the early scoring of deficits and lays the foundation for the early prediction of physical disability.

NCT ID: NCT04285437 Recruiting - Breastfeeding Clinical Trials

The Effects of Massage Therapy on Term Neonates Development and on Maternal Bonding

Start date: January 31, 2020
Phase: N/A
Study type: Interventional

This study collects data from 2 groups of mother- term neonate pairs at the Neonatal Department of Children Hospital II, Ho Chi Minh City (in group M: neonates are massaged by their mothers during the first 2 months after birth, in group X: neonates are not massaged), and then, evaluates the effects of Massage Therapy on the mental and physical development of neonates and on maternal bonding (breast feeding, postnatal depression) during the first 2 months after birth.

NCT ID: NCT03828708 Recruiting - Infant Development Clinical Trials

Early Iron Exposure on the Gut Microbiota in Young Infants

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

This study will look at the amount of iron in infant formula and how that affects a child's gut development. The children of mothers who plan to formula feed their children will be randomized to receive either high iron or low iron formula from birth until 4 months of age. Infants will consume only the study provided formula during enrollment. Blood and stool samples will be collected at birth and end of study to measure the effects of the iron exposure. The overall object is to compare high iron versus low iron exposure in formula-fed infants during the first months of life. Aims include determining the types of bacteria that are present in the infants' fecal microbiome, determining the effect of high iron exposure on gut microbiome and sleep patterns, and comparing iron status and homeostasis between the low and high iron formula groups.

NCT ID: NCT02683473 Recruiting - Infant Development Clinical Trials

Measurement of Energy Metabolism in Infants

BabyEE Pilot
Start date: March 2016
Phase:
Study type: Observational

The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.

NCT ID: NCT02290756 Recruiting - Infant Development Clinical Trials

A Community Based Implementation of a Toolkit and Parenting Program for Improving Brain Development in Newborns

Start date: January 2015
Phase: N/A
Study type: Interventional

The investigators propose to develop and test the efficacy of a low cost evidence based toolkit aimed at improving brain development among newborns a rural setting of Pakistan. The toolkit will include a safe delivery kit, nutritional supplementation, and trainings on cord care, hypothermia management, aspiration and bag and mask techniques and APGAR score calculation. A simple, home-based parenting program will also be implemented that will teach parents tools that provide stimuli for brain and cognitive development in children. This parenting program covers Early Childhood Interventions for children at risk of developmental problems and covers developmental skill areas such as cognitive and fine motor, social and self-help and gross motor skills. Such an intervention package provides comprehensive care to families at the community level, with a minimal cost that can be scaled up. A new cadre of Link workers will be implemented who will provide mentoring and supportive supervision to Birth Attendants and will train parents in the stimulation program. The study will recruit 1080 pregnant women and their newborns.

NCT ID: NCT01274299 Recruiting - Infant Development Clinical Trials

Measurements of Facial Dimensions in Infants and Toddlers 0-4 Years of Age

Start date: November 2010
Phase: N/A
Study type: Observational

Anthropometric data of infants' face will be obtained using special 3D scanners and software.