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Development clinical trials

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NCT ID: NCT02272842 Active, not recruiting - Malnutrition Clinical Trials

Vitamin B12, Neurodevelopment and Growth in Nepal

BeLive
Start date: April 20, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is crucial for normal cell division and is necessary for brain growth as well as for the maintenance of its normal function. Deficiency is also associated with impaired growth. In a previous study, we demonstrated that vitamin B12 administration over a period of six months enhanced growth, and scores on a neuro-developmental test in young Indian children. However, the overall effect was small and, for the developmental scores significant only in those that were malnourished at the start of the study. Our findings need to be verified in trials targeting younger, malnourished children and with longer supplementation time. Hypothesis: This proposed study will test three hypotheses; to measure to what extent 2 recommended daily allowances (RDA) of vitamin B12 administration for one year to stunted children improves; 1) growth, 2) neurodevelopment, and 3) hemoglobin concentration. Study design: Randomized placebo-controlled trial. Half of the children will receive a paste containing vitamin B12, the other half the same paste but without vitamin B12. Study participants and site: 600 malnourished infants in Bhaktapur municipality in Nepal. In this population we have demonstrated that vitamin B12 deficiency and poor growth is common in early childhood. Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12 months Data: The main outcomes of this study are scores on developmental assessments tools and growth measured every month for 12 months.

NCT ID: NCT01869530 Recruiting - Obesity Clinical Trials

TARGet Kids!: Measuring Nutrition in Young Preschool Children in the Primary Care Practice Setting

TARGetKids!
Start date: July 2008
Phase:
Study type: Observational [Patient Registry]

TARGet Kids! (The Applied Research Group for Kids) is a research study enrolling healthy children aged 0-5 years. The aim of the TARGet Kids! registry is to link early life exposures to health problems including obesity, micronutrient deficiencies, and developmental problems. TARGet Kids! represents an innovative collaboration between child health researchers and children's primary care doctors (pediatricians and family physicians) to promote research that really matters and create solutions to some of the today's biggest health concerns. The results of this collaborative research study are not only improving the quality of children's healthcare but also the health of children across the country. Coordinated by Sick Kids and St. Michael's Hospital with data management services by the Applied Health Research Centre (AHRC), TARGet Kids! is the only primary care research network for children in Canada.

NCT ID: NCT01779661 Recruiting - Cerebral Palsy Clinical Trials

Infant Aquatics Neurodevelopment Premature Infants

IA-NPI
Start date: April 2013
Phase: N/A
Study type: Interventional

The objective of this research is to examine the effect of Infant Aquatics on the development of and neurodevelopment of preterm and near-term infants, using the GM as prognostic estimation of future development. Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants. The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.

NCT ID: NCT01742520 Recruiting - Development Clinical Trials

Neurodevelopmental Outcomes of Preterm Infants Treated for Pain Management With Repeated Doses of Sucrose 24%

Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effect of sucrose 24% for pain prevention on preterm infants. Our hypothesis is that repeated doses of sucrose 24%, given prior to painful procedure,do not impair neurodevelopmental outcomes of preterm infants

NCT ID: NCT01700205 Completed - Development Clinical Trials

Effect of Infant Formula on Energy Balance

GRO
Start date: November 2, 2012
Phase: N/A
Study type: Interventional

The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.

NCT ID: NCT01667549 Completed - Development Clinical Trials

Sensitive Periods in Human Flavor Learning

Start date: August 2012
Phase: N/A
Study type: Interventional

The goals of the proposed research are to specify the timing and consequences of the sensitive period for flavor learning in infants who are being breastfed or formula fed. The investigators will conduct a randomized within- and between-subject study of women and their infants during a 15-month window.

NCT ID: NCT01576003 Completed - Nutrition Clinical Trials

Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.

NCT ID: NCT01561547 Completed - Pain Clinical Trials

Trial of Repeated Analgesia With Kangaroo Care

TRAKC
Start date: June 2012
Phase: Phase 3
Study type: Interventional

Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful procedure. While evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. Current guidelines recommend sweet taste for minor painful procedures. Although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. The combination of KMC and sucrose is marginally more potent, but again, long term use remains unstudied. AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to usual care (sucrose), and of KMC in combination with sucrose by examining each condition at least three times during NICU stay. A secondary aim is to compare these interventions on neurodevelopment at discharge from the NICU.

NCT ID: NCT01191671 Completed - Child Clinical Trials

Language and Deglutition in Children

LDC
Start date: May 2009
Phase: N/A
Study type: Observational

The first years of life are considered essential to child development, as there is greater brain growth and formation of more neural connections. Therefore, the stimulation of children in various fields of development becomes relevant to the acquisition of knowledge and skills.

NCT ID: NCT01162798 Completed - Growth Clinical Trials

Preterm Infant Growth

Start date: September 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.