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Preterm Birth clinical trials

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NCT ID: NCT02830503 Completed - Preterm Birth Clinical Trials

Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life

Start date: June 2016
Phase: N/A
Study type: Interventional

Project summary Rationale Many NICU's replace their feeding tubes once a week or more rarely in order to avoid disturbing the infants. The researchers discovered that there are high concentrations of potentially pathogenic bacteria in the yield of resident nasogastric feeding tubes, even within one day of use (own data, manuscript submitted). Preterm infants are vulnerable to the colonization of the gut, and development of dysbiosis might lead to necrotizing enterocolitis. The researchers speculate if replacing the resident feeding tube every day and thereby decreasing the amount of potentially pathogenic bacteria given to the infants via the feeding tube will lead to fewer bacteria present in the upper part of the gastrointestinal tract of the infant and hence a reduced competition with probiotic colonization. Objectives The investigators plan to conduct an intervention study in premature infants receiving probiotics (< 32 weeks of gestation) where the feeding tube will be replaced every day in the intervention group and once a week (standard practice) in the control group. The main outcome will be bacterial concentration in the stomach after one week of life. Methods The study is a prospective, randomized controlled trial in preterm infants. Infants will be randomized to the intervention group in which the tube is replaced every day or the control group which will follow normal practice in the department. The intervention will last one week. The infants will be followed until discharge. The investigators plan to include 11 infants in each group. Primary outcome Concentration of bacteria in gastric aspirates on day seven.

NCT ID: NCT02787213 Completed - Preterm Birth Clinical Trials

A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

TREETOP
Start date: August 2016
Phase:
Study type: Observational

Prospective multicenter observational study to further develop and validate a preterm birth risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks gestation. A single maternal peripheral blood sample will be collected for analysis. Data related to potential risk factors for preterm birth will be obtained through maternal interview and review of medical records. Subjects will be followed through the delivery process to assess the course of pregnancy, labor, and to document any related maternal complications. Neonatal outcomes will be gathered from the medical record for up to 28 days of life or discharge, whichever occurs first.

NCT ID: NCT02772835 Completed - Preterm Birth Clinical Trials

nHFOV vs nCPAP: Effects on Gas Exchange for the Treatment of Neonates Recovering From RDS

Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effects of two different techniques of non-invasive ventilation (nCPAP and nHFOV) on gas exchange in preterm infants recovering from respiratory distress syndrome.

NCT ID: NCT02723513 Completed - Preterm Birth Clinical Trials

Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term to characterize and probe the relationship between lung structure and function using imaging.

NCT ID: NCT02716909 Completed - Preterm Birth Clinical Trials

Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

Start date: March 2016
Phase: Phase 3
Study type: Interventional

Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB. The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.

NCT ID: NCT02697331 Completed - Preterm Birth Clinical Trials

Vaginal Progesterone in Twin With Short Cervix

Start date: April 5, 2016
Phase: Phase 3
Study type: Interventional

Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix . Study Design: The study is designed as randomized ,placebo-controlled, clinical trial . All women with dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out patient clinic. Randomization of cases will be done by computer method . 156 women with dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm detected on transvaginal sonogram between 20w to 24w gestational age were enrolled in the study and were distributed in two groups:group P (cases ) and group N (controls) . The randomization allocation was 1 : 1 (vaginal progesterone capsule : placebo).

NCT ID: NCT02693041 Completed - Preterm Birth Clinical Trials

Pregnancy Complications - A Probiotic Interventional Study

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

Investigators hypothesize that a) probiotics decrease the overall inflammatory state in the pregnant woman, especially in women with high risk pregnancies.

NCT ID: NCT02692820 Completed - Preterm Birth Clinical Trials

Preventing Preterm Birth With Probiotics

PrePro
Start date: May 2016
Phase: N/A
Study type: Interventional

Babies born preterm (before completing 37 weeks in the womb) are at increased risk of long-term disability and death. The investigators do not fully understand the cause(s) of preterm birth but it occurs more frequently when the normal, healthy bacteria (called Lactobacilli) in a woman's birth canal are replaced with unhealthy bacteria. Previous attempts to get rid of the unhealthy bacteria with antibiotics have not shown to affect the risk of preterm birth. The reason for this may be that what is required is the replacement of Lactobacilli in the birth canal. This can be done by asking women to take capsules containing lactobacilli once daily. To study whether oral Lactobacilli capsules compared with dummy capsules can reduce the risk of preterm birth, a large study involving approximately 10,000 women would be required. But the investigators do not know whether women would agree to take part in and complete such a study, and this is what the investigators wish to study in the small, initial study described here. The results of this study will show whether probiotics produce the desired biological effects on vaginal bacteria, and whether it would be feasible to perform the larger, definitive study of their effectiveness in prevention of preterm birth.

NCT ID: NCT02662790 Completed - Preterm Birth Clinical Trials

Dexamethasone on Fetal and Uteroplacental Doppler

Start date: February 2014
Phase: Phase 2
Study type: Interventional

The current study aims to investigate the effects of dexamethasone exerted on fetal and uteroplacental circulation as measured by Doppler ultrasonography in pregnancies at risk for preterm birth after 24 hours of its administration.

NCT ID: NCT02640638 Completed - Pregnancy Clinical Trials

A RCT of CenteringPregnancy on Birth Outcomes

CRADLE
Start date: February 24, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether CenteringPregnancy group prenatal care can improve preterm birth rate and other birth outcomes, maternal psychosocial and behavioral outcomes, and decrease the racial difference in selected birth outcomes among African American and White women, compared to individual prenatal care.