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Premature Birth clinical trials

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NCT ID: NCT01713894 Completed - Clinical trials for Prematurity; Decision Support

Decision Aid - Extreme Prematurity

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

The purpose of this study is to assess in a pilot randomized controlled trial the following PICOT question: In parents facing extreme premature delivery, does the use of an existing validated visual decision aid as compared to standard counseling, reduce the primary outcome of parental decisional conflict? Furthermore, is such a decision aid understood and applicable across differing populations of different ethnic backgrounds and social classes?

NCT ID: NCT01697904 Completed - Oxidative Stress Clinical Trials

Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns

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

Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.

NCT ID: NCT01686685 Completed - Clinical trials for Autism Spectrum Disorder

Correlation of CXCR4 Expression in Premature Infants With a Diagnosis of Autism at 24 Months

ASD-CXCR4
Start date: September 2013
Phase:
Study type: Observational

Preterm children are at increased risk for autism spectrum disorders, with an estimated rate of 10%. In the US, about 1 in 8 pregnancies ends with a premature birth. Therefore, individuals with ASD who were born prematurely form a substantial body of children diagnosed with ASD. Premature birth confers an insult to the newborn at a neurologically vulnerable stage. Prematurity associated changes in oxygen tension can be detrimental to developing organs, the brain being one of the most rapidly developing organs in the second half of the pregnancy. Changes in oxygen tension mediate activation of proteins that change the course of cell development. In this study, we plan to measure changes in the expression of 3 proteins that may be affected by changes in oxygen level at birth. We will study the interaction between the proteins' levels in the first few days after premature birth with a diagnosis of ASD at 2 years of age. The proteins are: 1. VEGF (Vascular Endothelial Growth Factor), a protein that takes part in creating new blood vessels during embryonic development. 2. Hypoxia-inducible factor -1(HIF-1), a key protein that coordinates expression of different genes, many with developmentally critical functions. 3. CXCR4, a cell surface protein that is activated by SDF-1. SDF- 1 is a molecule that regulates migration of cells to their target destination during embryonic life. CXCR4 is expressed in areas of the brain and on cells that are known to be associated with ASD. We hypothesis that changes in oxygen tension in premature babies initiates a cascade of events that lead to changes in cell mobility via abnormal CXCR4 expression. This change leads to abnormal neurodevelopment. The investigators' primary aim is to find if there is a correlation between postnatal levels of expression of HIF-1, CXCR4 and VEGF and a diagnosis of autism at age 24 months. The investigators' secondary aim is to find if there is a correlation between postnatal levels of expression of HIF-1, CXCR4 and VEGF and a language or neurocognitive delay. Methods: 1. Premature babies will be recruited in the first day post delivery. 2. Blood samples will be collected at 3 time points during their hospitalization, and the expression of HIF-1, CXCR4 and VEGF will be determined. 3. Infants will undergo a complete developmental evaluation at 18-24 months of age . 4. Postnatal levels of HIF, CXCR4 and VEGF will be plotted against the results of the developmental evaluation.

NCT ID: NCT01683565 Completed - Preterm Birth Clinical Trials

Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood

Start date: September 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help development and behavior of children born preterm.

NCT ID: NCT01678638 Completed - Inguinal Hernia Clinical Trials

Timing of Inguinal Hernia Repair in Premature Infants

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

The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia.

NCT ID: NCT01675726 Completed - Clinical trials for CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

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

AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL reported by a French general population of reference. 3) to determine whether socio-demographic factors, neonatal features and neurocognitive status were impacting their QoL. METHODS: - Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier, Nantes, Nîmes, Nice and Rouen). - Inclusion criteria: all infants born before 28 weeks of gestation between January 2005 and December 2007, from 7 to 9 years old of age at the time of evaluation. - Written agreement to participate: collected from parents. - Data collection: reports of children's QoL by children and their parents (using standardized validated questionnaires); clinical information about the children, obtained through a medical examination; children neurocognitive profile. - Duration of inclusion: over 24 months. - Population: of the six structures, approximately 300 children will be evaluated consistent with the active files of the participating centres and an attrition rate of 30%. PERSPECTIVES This is one of the first studies to collect self-reported data on quality of life of school-age children (7-9 years) born before 28 weeks of gestation. A better understanding of demographic and clinical determinants of QOL of school-age very preterm children may help clinicians involved in the care of these children in their ethical and medical considerations.

NCT ID: NCT01665378 Completed - Anemia Clinical Trials

Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes

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

The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.

NCT ID: NCT01660620 Completed - Clinical trials for Development of Side Effects From Betaxolol

Topical Betaxolol for the Prevention of Retinopathy of Prematurity

Start date: April 2011
Phase: Phase 1
Study type: Interventional

We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.

NCT ID: NCT01649362 Completed - Preterm Infant Clinical Trials

Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants

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

The objective of this study is to evaluate the efficacy of an oral stimulation program on the length of the transition period in preterm infants (primary outcome), the length of hospital stay and the breastfeeding rates at discharge (secondary outcomes).

NCT ID: NCT01648855 Completed - Preterm Birth Clinical Trials

Consequences of Antiangiogenic Factors Involved in Preeclampsia on Intra-uterine Growth Restricted Preterm Newborn

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

Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal and neonatal morbidity and mortality worldwide. Imbalance between circulating angiogenic and antiangiogenic factors has emerged as a potential key pathway in the pathophysiology of preeclampsia. Patients with preeclampsia have a higher circulating concentration of antiangiogenic factors (ie, soluble vascular endothelial growth factor receptor-1 [sVEGFR- 1], also called soluble fms-like tyrosine kinase 1 [sFlt1]) and soluble endoglin (sEng)] and a lower maternal circulating concentration of free angiogenic factors (ie, vascular endothelial growth factor [VEGF] and placental growth factor [PlGF]) than patients with a normal pregnancy. Bronchopulmonary dysplasia is the main respiratory sequelae of preterm birth. Its rate increased in preterm infants born from mother with preeclampsia. Recent studies showed that bronchopulmonary dysplasia is consistently accompanied by a reduction in the number of small arteries and on abnormal distribution of vessels within the distal lungs. This is associated with reduced lung VEGF expression. The main objective of this population-based study, ie in intra uterine growth restricted preterm babies born before 30 weeks of gestational age, was to examine whether levels of sFlt1 at birth in maternal and umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD.