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Infant, Very Low Birth Weight clinical trials

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NCT ID: NCT02039583 Completed - Stillbirth Clinical Trials

Impact of Smoke-free Legislation on Early-life Mortality and Low Birth Weight in England

Start date: January 1995
Phase: N/A
Study type: Observational

The purpose of this study is to investigate whether there has been a change in low birth weight and perinatal and infant mortality following the July 2007 introduction of a ban on smoking in public places and workplaces in England.

NCT ID: NCT01785563 Completed - Clinical trials for Infant, Very Low Birth Weight

Nasal Noninvasive NAVA in the Very Low Birth Weight Infant

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

The purpose of this study is to determine if a new type of mechanical ventilation, or breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide additional support to infants who were born prematurely. Investigators are looking to determine if in two hours infants who weighed less than 1500 grams or 3 pounds 5 ounces, will demonstrate a decrease in the amount of carbon dioxide (the gas that humans exhale) dissolved in their blood as compared to prior to starting the study. This will be accomplished by enrolling infants who are stable on their current type of mechanical breathing that provides a constant air flow into the infant. This type of mechanical support helps keep the lungs inflated but does not help remove carbon dioxide. This study will change the type of mechanical support to a type of support called neurally adjusted ventilatory assist or NAVA. This type of mechanical support detects when the infant is breathing in by having electrical sensors on a feeding tube that is placed into the stomach through the nose or mouth. These electrical sensors detect when the diaphragm or the muscle that helps humans breath is trying to take a breath in. When the NAVA ventilator senses the attempt to breath, it provides additional air flow to make the effort of breathing easier. The ventilator will be attached to a tube or cannula that is placed into the infant's nose. After two hours of being on the NAVA ventilator a repeat measure of carbon dioxide in the blood will be performed by taking a small amount of blood from the infant's heel.

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: 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: 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: 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.

NCT ID: NCT01124331 Completed - Clinical trials for Bronchopulmonary Dysplasia

Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis

NeOProM
Start date: March 2005
Phase: N/A
Study type: Interventional

The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?

NCT ID: NCT00760942 Completed - Clinical trials for Infant, Very Low Birth Weight

Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

Start date: October 2008
Phase: N/A
Study type: Interventional

This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.