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Premature Birth clinical trials

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NCT ID: NCT02707237 Completed - Pregnancy Preterm Clinical Trials

Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling

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

Providing verbal counseling supplemented with both written and pictorial information then verbal counseling alone is a more effective method of counseling parents with threatened preterm delivery

NCT ID: NCT02702297 Completed - Clinical trials for Preterm Premature Rupture of Membranes

Multimodal Monitoring of Fetal Risk of Inflammation in Preterm Premature Rupture of Membranes

MuMFI-PPROM
Start date: January 7, 2016
Phase:
Study type: Observational

The purpose of this study is to examine whether the value of vaginal fluid cytokine levels as well as computerized fetal ECG analysis are suitable clinical parameters to detect an imminent intra-amniotic inflammation with a high risk of fetal inflammatory response syndrome (FIRS) or a neonatal early onset sepsis (EOS) and whether these parameters can be determined on a daily basis in the clinical monitoring of pregnancies complicated by PPROM.

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: NCT02696889 Completed - Clinical trials for Premature Ovarian Failure

Rejuvenation of Premature Ovarian Failure With Stem Cells

ROSE-1
Start date: February 6, 2016
Phase: N/A
Study type: Interventional

The ROSE-1 study is designed to determine the efficacy of bone marrow derived stem cell therapy on ovarian function recovery in subjects with idiopathic and other types of premature or primary ovarian failure (POF or POI) and low ovarian reserves.

NCT ID: NCT02694679 Completed - Diarrhea Clinical Trials

Randomized Controlled Trial of Social Network Targeting in Honduras

Start date: June 2015
Phase: N/A
Study type: Interventional

Social network targeting strategies can be used to improve the delivery and uptake of health interventions. We will enroll approximately 30,000 individuals into a randomized controlled trial of different targeting algorithms in order to explore how social network dynamics affect the uptake, diffusion, and group-level normative reinforcement of key neonatal and infant health behaviors and attitudes in 176 rural villages in the Copan region of Honduras. Our goal is to develop methods by which global health practitioners can exploit face-to-face social network interactions in order to maximize uptake of neonatal and infant health interventions. The villages will be randomly assigned to 16 cells of 11 villages each in a 2 x 8 factorial design of different targeting algorithms.

NCT ID: NCT02694510 Completed - Clinical trials for Oxidative Stress in Preterm Infants

Light Protection of TPN and Oxidative Stress in Preterm Infants

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be measured in preterm infants less than 32 weeks gestation before and 7 days after receiving either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN) solutions.

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: NCT02688010 Completed - Preterm Infants Clinical Trials

Effect of Reduced Noise Levels and Cycled Light on Visual and Neural Development in Preterm Infants

Start date: January 8, 2016
Phase: N/A
Study type: Interventional

Noise is a hazard for newborn. In 1997, the American Academy of Pediatrics determined that safe sound levels in the neonatal intensive care unit (NICU) should not exceed 45 dB which has been rarely achieved. High intensities of noise have several negative effects on preterm newborns. Also, they are exposed to either continuous bright light continuous near darkness or unstructured combination of the two during their hospitalizations. The investigators primary objective is to determine the impact of reduced noise levels and cycled light on growth parameters and visual development in preterm infants.

NCT ID: NCT02686060 Completed - Clinical trials for Babies Born Very Preterm

In-line Filtration to Reduce Systemic Inflammatory Response Syndrome in Babies Born Very prEtErm

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

While venous access is an essential part of caring for the preterm neonate potential severe adverse events, including contamination of fluids with bacteria, endotoxins and particulates could occur (Bethune 2001). Infusion therapy carries a risk for catheter-associated septicaemia (Geiss 1992) originated from the catheter tubing, the ports, at the cannula site or from contaminated infusion fluid. While not all infections lead to septicaemia, immuno-compromised patients such as neonates are at greater risk, and infection becomes a major problem (Ng 1989) and a major risk factor for neurodevelopmental disabilities (Volpe 2008). Indeed, it has been postulated that endotoxins may be involved in the pathogenesis of a proportion of cases of periventricular leukomalacia, the most frequent brain damage associated with neurocognitive handicaps in the human neonate (Volpe 2001). The presence of calcium in parenteral nutrition mixture leads to precipitation due to its incompatibility with the other components of the admixtures and leads to high concentration of particles (Athanasiou 2014). Adverse systemic effects of particulate matter including phlebitis, granulomata formation in the lung (Marshall 1987) and ischaemic necrosis, are a common finding in necrotizing enterocolitis another serious complication flowing preterm birth (Ballance 1990). Particle contamination of infusion solutions exists despite a stringent infusion regiment. The number and composition of particles depends on the complexity of the applied admixtures (Jack 2010). Particulate contamination is due to drug incompatibility reactions or their incomplete reconstitution during the preparation process (Schroder 1994). Various studies have demonstrated the contamination of infusion solutions with glass particles from opening glass ampoules, particles from rubber stoppers or conglomerates of the parenteral nutrition components (Ball 2003). Particles have also been shown to be inherent to generic drug formulation (Oie 2005). In an intensive care setting the particle burden may rise up to one million infused particles per day, increasing with the complexity and quantity of the administered infusions (Walpot 1989). There are two main IV filter pore sizes; the 0.2 micron filter is used for aqueous solutions, and the 1.2 micron filter is recommended for larger molecule solutions such as lipids. The 0.2 micron filter has also been reported to remove air, microorganisms and particulate matter. In addition, endotoxin retention is reportedly achieved by using a positively charged filter membrane; toxic macro-molecules are released by gram-negative bacteria and are claimed to be effective for up to ninety six hours (Bethune 2001). In-line IV filters are currently claimed to be an effective strategy for the removal of bacteria, endotoxins and particulates associated with intravenous therapy in adults (Ball 2003) and particularly effective in the removal of particles caused from drug precipitate such as antibiotics (Chee 2002; Ball 2003). However, evidence of the beneficial effect of in-line IV filters in children and neonates is much weaker, despite some positive studies (Jack 2012; Boehne 2013; Sasse 2015). In the population of preterm infants, no study is currently available while particulate contamination due to infusion therapy carries a higher health risk in this subpopulation. The benefits of using IV in-line filters in critically-ill preterm neonates remains to be demonstrated. This intervention in adults has also been challenged by several authors (Pearson 1996; Newell 1998). Friedland reported that certain drugs such as antibiotics may be retained in the filters causing a reduction in potency (Friedland 1985). On the other hand, there are no known adverse effects from the use of IV in-line filters.