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Infant, Premature, Diseases clinical trials

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NCT ID: NCT01735578 Completed - Clinical trials for Necrotizing Enterocolitis

Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis

Start date: October 2012
Phase: N/A
Study type: Observational

Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in the newborn intensive care unit and represents a significant cause of morbidity and mortality in infants born prematurely. Among possible risk factors, a strong association between elective RBC transfusions in premature infants with anemia and the subsequent development of NEC has been consistently observed (6-11). However, a significant (and increasing) number of VLBW infants with anemia are managed with erythropoiesis stimulating agents (such as Epo) and iron and do not receive RBC transfusions during their hospital stay. The present study proposes to study this particular group of VLBW infants that remain with low (<28 %) hematocrit while receiving full enteral feedings. The investigators hypothesize that significant anemia in VLBW infants will be associated with a baseline low cerebro-splanchnic oxygenation ratio (CSOR) (<0.75) as measured by NIRS, and that nasogastric feedings (NGF) in those particular patients will lead to further decreased splanchnic oxygenation. The investigators further postulate that CSOR values will be significantly lower among VLBW that develop NEC as compared to infants that do not.

NCT ID: NCT01735552 Terminated - Clinical trials for Necrotizing Enterocolitis

Transfusion-related Inflammatory Cytokine and Neutrophil Extracellular Trap Quantification in Neonates

Start date: June 2012
Phase: N/A
Study type: Observational

Despite many advances in neonatal care, necrotizing enterocolitis (NEC) remains a leading cause of morbidity and mortality among premature infants. NEC is the most common life-threatening gastrointestinal emergency encountered in the neonatal intensive care unit, affecting between 3.8% and 13% of very low birthweight (VLBW) infants (1-3). More recently interest has intensified regarding the possible association between "elective" red blood cell (RBC) transfusions in premature infants and the subsequent development of NEC (4-9). On a physiological basis, a few explanations for transfusion-associated NEC have been proposed: 1) the physiological impact of anemia that can initiate a cascade of events leading to ischemic-hypoxemic mucosal gut injury predisposing to NEC [10]; and 2) increased splanchnic blood flow following RBC transfusion leading to reperfusion injury of gut mucosa. Aim 1. This study will quantify inflammatory cytokine profiles in anemic infants cared for in the NICU prior to and after transfusion with packed red blood cells (PRBC), as dictated by current clinical guidelines for treatment of anemia, and prospectively assess for clinical signs and symptoms of NEC following each transfusion event. Aim 2. Polymorphonuclear leukocytes (PMNs) isolated from the pre- and post-transfusion blood samples will be assessed in vitro for neutrophil extracellular traps (NET) formation. Aim 3. A) To determine whether significant anemia preceding a RBC transfusion is associated with impaired intestinal oxygenation, and whether a RBC transfusion temporarily increases splanchnic oxygenation. We postulate that the CSOR will be low (<0.75) at baseline measurement in infants with hemodynamically significant anemia, and that RBC transfusion will temporarily increase intestinal perfusion in that particular group of babies. B) To determine whether alterations in mesenteric regional oxygenation saturation(rSO2) can predict the development of NEC in VLBW infants. We hypothesize that overall cerebro-splanchnic oxygenation ratio (CSOR) values will be significantly lower among very low birth weight (VLBW) infants that develop NEC, when compared to CSOR values obtained in infants that do not develop NEC following RBC transfusion.

NCT ID: NCT01731613 Completed - Clinical trials for Infant, Premature, Diseases

Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

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

This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.

NCT ID: NCT01626508 Completed - Clinical trials for Infant, Premature, Diseases

Prospective Evaluation in Older Premature, Untreated Breast Milk and Milk Processed by the Breast-milk Bank

ADiLL
Start date: June 2012
Phase:
Study type: Observational

The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution of the total content and plasma profile of essential fatty acids (EFA) in a population of premature infants.

NCT ID: NCT01539356 Completed - Neonatal Sepsis Clinical Trials

Hepcidin Levels in Preterm Infants

Start date: March 2012
Phase: N/A
Study type: Observational

A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron retention in reticuloendothelial cells. The aims of this study were to determine serum hepcidin levels in preterm infants who receive blood transfusion and preterm infants having sepsis, in order to assess possible relationships between hepcidin and serum iron, serum ferritin,in iron load situations.

NCT ID: NCT01486173 Active, not recruiting - Clinical trials for Infant, Premature, Diseases

Early Nutrition and Neurological Development of Very Preterm Infants

EPINUTRI
Start date: June 2011
Phase: N/A
Study type: Observational

The main goal of this study is to determine the association between: - the quantity of mother's milk and duration of breastfeeding - the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA < 32 weeks.

NCT ID: NCT01304394 Completed - Clinical trials for Infant, Premature, Diseases

Safety During Use of Paediatric Triple Chamber Bag Formulas

Start date: February 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to provide daily information on the performance safety of the Ped3CB in practical therapeutic use in pediatric patients.

NCT ID: NCT01181791 Terminated - Clinical trials for Premature Infant Disease

Effects of Lactobacillus Reuteri in Premature Infants

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

This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants. The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.

NCT ID: NCT01150396 Recruiting - Clinical trials for Infant, Premature, Diseases

Prognosis of Extremely Premature Birth

BabyPEP
Start date: July 2010
Phase: N/A
Study type: Observational

Pregnant women at risk of giving birth before 28 weeks' gestational age will be enrolled. Fetal circulation will be studied and blood for inflammatory parameters will be collected. If birth occurs before 28 weeks, detailed information on clinical course of the newborn until discharge from the neonatal intensive care unit will be recorded,and specimens of amniotic fluid, placenta, blood and urine will be collection for inflammatory parameters. After discharge the children will be followed according to a specific protocol until 5 years of age.

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)?