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Infant, Very Low Birth Weight clinical trials

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NCT ID: NCT01717625 Completed - Premature Birth Clinical Trials

The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia

BPD
Start date: November 2011
Phase: Phase 2
Study type: Interventional

This study is multicentered, prospective, randomized, opened, parallel, intervention study. The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia (BPD) in preterm infant, below 32weeks gestational age. The investigators evaluate the first effectiveness through the morbidity and mortality of bronchopulmonary dysplasia. And then, the investigators evaluate the second effectiveness through the oxygen index, the usage of mechanical ventilator about taking medicine after 2 Weeks, Oxygen Utilization After 4 Weeks, Proinflammatory Cytokine through the bronchial lavage fluid.

NCT ID: NCT01518452 Completed - Clinical trials for Infant, Very Low Birth Weight

Computerized Working Memory Training in Very-low-birth-weight Children at Preschool Age

Start date: April 2011
Phase: N/A
Study type: Interventional

The main aim of this prospective interventional study is to compare quantitative EEG findings and cognitive and neuropsychological test results before and after training with the Cogmed JM program in a group of very-low-birth-weight children in preschool age, i.e. ages 5-6 years. The investigators hypothesize that the children in the study may respond positively to the computerized training and improve working memory, but probably to different degrees depending on the underlying neurological condition. The investigators also hypothesize that training may benefit additional executive functions.

NCT ID: NCT01430832 Terminated - Clinical trials for Post Traumatic Stress Disorder

Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

Start date: September 1, 2011
Phase:
Study type: Observational

The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.

NCT ID: NCT01430728 Recruiting - Clinical trials for Infant, Very Low Birth Weight

Cerebral Tissue Oxygenation in Very Low Birthweight Infants in the First 3 Days of Life

Start date: April 2011
Phase: N/A
Study type: Observational

The purpose of this study is to examine the range of cerebral tissue oxygen saturation in healthy and sick very low birthweight infants during the first 72 hours of life.

NCT ID: NCT01363167 Completed - Clinical trials for Vitamin D Deficiency

Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2

Start date: October 2011
Phase: N/A
Study type: Interventional

This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.

NCT ID: NCT01353313 Active, not recruiting - Clinical trials for Bronchopulmonary Dysplasia

Hydrocortisone for BPD

Start date: August 11, 2011
Phase: Phase 3
Study type: Interventional

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.

NCT ID: NCT01341236 Completed - Clinical trials for Infant, Very Low Birth Weight

Near Infrared Spectroscopy (NIRS) and Superior Mesenteric Artery (SMA) Doppler Patterns as Predictor of Feeding Tolerance in Very Low Birth Weight (VLBW) IntraUterine Growth Restricted (IUGR) and NON IUGR Infants

Start date: September 2011
Phase: Phase 4
Study type: Interventional

This study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (IUGR) or NON-IUGR STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10 children) and NON-IUGR infants (approximately 10 children). PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN). SECONDARY ENDPOINT: - To compare if changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants; - To compare growth and nutritional status of the 2 groups by randomized arm. - To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of Near Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the transitional period, between the 48th and 72nd hours of life, all infants' intestinal perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery will be executed. - To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance (need of interruption of enteral feeding). DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW babies. Duration of the study: 24 months. INCLUSION CRITERIA - Weight at birth ranging: 700 - 1501 grams; - Gestational age up to 25 weeks and 6 days; - Written informed consent from parents or guardians EXCLUSION CRITERIA - Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract) - Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC) - Pre-existing cutaneous disease not allowing the placement of the probe

NCT ID: NCT01204983 Recruiting - Clinical trials for Infant, Very Low Birth Weight

Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU

NICU
Start date: July 2010
Phase:
Study type: Observational

Human milk is associated with substantial benefits to infants' health and development, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. The use of donor human milk as an alternative to cow milk in these infants has risen dramatically in the past year. However, there have been recent reports of hyperphosphatemia and hyponatremia associated with the consumption of donor human milk products. These electrolyte imbalances can lead to concerning symptoms, including headache, nausea, vomiting, altered mental status, coma, seizures, or heart failure. It is important to recognize and appropriately treat these electrolyte disturbances associated with donor human milk to avoid potential nutritional problems.

NCT ID: NCT01193270 Completed - Infant, Premature Clinical Trials

Vitamin E for Extremely Preterm Infants

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth weight). This pilot will examine whether a single dose of vitamin E will be absorbed into the infants' bloodstreams with resulting serum α-tocopherol level in the target range of 1-3 mg/dl.

NCT ID: NCT01167517 Completed - Lactation Clinical Trials

Lactation Education Study in Mothers of Very Low Birth Weight Infants

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

This study will test the effectiveness of breast milk expression discharge instructions in digital video disc (DVD) format for home use by mothers of very low birth weight infants on the dose and duration of mother's breast milk feeding in their infants compared to breast milk expression discharge instructions in printed format. The investigators hypothesize that infants whose mothers receive breast milk expression discharge instructions via DVD will receive a larger dose of maternal breast milk and for longer duration during the initial neonatal intensive care unit hospitalization than infants whose mothers receive discharge instructions in printed format.