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Premature Birth clinical trials

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NCT ID: NCT01538030 Completed - Premature Rupture Clinical Trials

Perinatal Outcome After Premature Rupture of Membranes

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

Premature rupture of membranes is an important cause of neonatal morbidity and mortality, mainly because of the complications associated with this pathology (oligohydramnios, cord compression or prolapse, infection). When rupture of the membranes occur the risk of cord compression increases but there is little evidence regarding this complication and amniotic fluid volume. The investigator's focus are the perinatal outcomes according to amniotic fluid volume (< 5 or >5).

NCT ID: NCT01523769 Completed - Prematurity Clinical Trials

Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants

Start date: September 2009
Phase: N/A
Study type: Interventional

Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these infants have higher circulating blood volume in the first 24 hours, less need for blood transfusions, and less incidence of intraventricular hemorrhage. Delayed umbilical cord clamping has also been shown to increase the initial hematocrit and decrease the need for red blood cell (RBC) transfusions compared with no intervention in infants born between 27 and 33 weeks' gestation. However, a delay in cord clamping of 30-45 seconds may theoretically interfere with neonatal resuscitation. There have been few studies that addressed the active milking of the cord and its effect on neonatal resuscitation. Active milking of the umbilical cord towards the baby prior to clamping (rather than passive) should take less than 5 seconds to perform and should not interfere with neonatal resuscitation. Umbilical cord milking, as an alternative to delayed cord clamping, has been shown to increase the circulatory blood volume expressed as the hemoglobin value. Active milking of the cord prior to clamping, however, is not considered standard of care and only 1 Japanese randomized control study has reported that umbilical cord milking reduces the need for RBC transfusions, thus reducing the number of infants requiring a RBC transfusion as compared with control conditions. Our study aims to test the hypothesis that active milking of the umbilical cord will reduce the need for transfusion in preterm infants.

NCT ID: NCT01523483 Completed - Preterm Birth Clinical Trials

Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor

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

The investigators study objective is to investigate the effectiveness of vaginal micronized progesterone in prolonging pregnancy after an episode of preterm labor which responded to tocolytic treatment. Furthermore, the investigators aim is to study the mechanisms of actions of progesterone supplementation by examining its effect on the two components of parturition: cervical ripening and myometrial contractility. The investigators will utilize transvaginal ultrasound to assess the changes in the cervical tissue, and non-invasive trans-abdominal uterine EMG to assess the uterine muscle activity. The investigators will also look at the effect of progesterone on contraction frequency by tocodynamometer (TOCO), though EMG is expected to provide much more information.

NCT ID: NCT01514747 Completed - Premature Birth Clinical Trials

A MRI Study of Visual and Motor Pathways in Premature Infants

Start date: October 2011
Phase:
Study type: Observational

Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the US. These babies often have motor and/or visual problems when they grow up. It is very important to identify high risk ELBW infants as early as possible, so that the investigators can treat them earlier to prevent poor development. Neurological examination at early age is not good enough to identify high risk ELBW infants. One the other hand, some magnetic resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at a very early age to predict long−term outcome and to identify infants who are at high risk of having motor and/or visual problems when they grow up.

NCT ID: NCT01503606 Completed - Clinical trials for Preterm Premature Rupture of Membrane

Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane

Start date: October 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.

NCT ID: NCT01499732 Completed - Healthy Clinical Trials

Exploratory Trial to Evaluate Premature Endothelial Dysfunction in Early Rheumatoid Arthritis(RA)Compared to Patients With Established RA, and Normal Subjects

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

Premature Endothelial Dysfunction is present in patients with early rheumatoid arthritis.

NCT ID: NCT01487928 Completed - Prematurity Clinical Trials

Human Milk Cream as a Caloric Supplement in Pre-Term Infants

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

Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.

NCT ID: NCT01487824 Completed - Preterm Birth Clinical Trials

What is the Impact of Early Life Exposures on the Cardiovascular System in Young Adulthood?

EVS
Start date: May 2007
Phase:
Study type: Observational

The purpose of this study is to investigate whether early life exposures such as premature birth or exposure to preeclampsia before you are born results in long-term alterations in the cardiovascular system that increase risk of cardiovascular disease development.

NCT ID: NCT01473264 Completed - Clinical trials for Bronchopulmonary Dysplasia

Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)

Start date: January 2000
Phase: Phase 1/Phase 2
Study type: Interventional

Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection. These conditions initiate an inflammatory response characterized by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the development of significant acute and chronic lung injury. The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10 is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and is the most abundant protein in the mucosal fluids in normal healthy lungs. The purpose of this study was to evaluate the pharmacokinetics, safety, tolerability and anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated premature infants receiving positive pressure ventilation for treatment of respiratory distress syndrome (RDS) to prevent long term respiratory complications referred to as bronchopulmonary dysplasia, and, more recently, as chronic respiratory morbidity (CRM; asthma, cough, wheezing, multiple respiratory infections). CC10 regulates inflammatory responses and protects the structural integrity of pulmonary tissue while preserving pulmonary mechanical function during various insults (eg. viral infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties suggest that administration of rhCC10 may help to facilitate development of normal airway epithelia and prevent the inflammation that leads to CRM in these infants.

NCT ID: NCT01469650 Completed - Premature Infants Clinical Trials

Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants

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

This study will determine levels of vitamin D supplementation to achieve goal serum 25-hydroxy vitamin D [25(OH)D] levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in Newborn Intensive Care Nursery (NICU). Infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day.