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Premature Birth clinical trials

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NCT ID: NCT03589365 Not yet recruiting - Preterm Birth Clinical Trials

Preterm Birth and Long Term Consequences on Myocardial Functions and Structure

PREMACOEUR
Start date: July 2018
Phase: N/A
Study type: Interventional

Cardiovascular diseases (hypertension, coronary heart disease, stroke and cardiac insufficiency) are the leading cause of death worldwide. They are a major cause of concern in public health worldwide as well. Their incidence is increasing especially in emerging countries. It has been shown through epidemiological and experimental studies that these cardiovascular diseases are influenced by environmental factors which can act early during different periods of the development. Preterm birth is an emerging risk factor of cardiovascular diseases. Preterm birth rate varies accordingly to countries from 6 % to 14 % and accounts for 80% of low birth weight. These past thirty years have shown an improvement in the management and survival rate of these babies. The number of preterm infants reaching adulthood is thus increasing. Long term effects of preterm birth on cardiovascular diseases are little known. However, emerging evidence suggest that preterm birth affects certain functions and structure. A significant increase in blood pressure and alterations on the vascular, metabolic, and renal systems have been reported in healthy young adult born preterm. And abnormal heart shape with left ventricular hypertrophy have been demonstrated in these population (Oxford)

NCT ID: NCT03535480 Not yet recruiting - Clinical trials for Premature Ovarian Failure (POF)

Autologous Bone Marrow Stem Cell Ovarian Transplantation to Restore Ovarian Function in Premature Ovarian Failure

ASCOT-2
Start date: June 2018
Phase: Phase 4
Study type: Interventional

This study aims to recover ovarian function in POF/POI patients. With this pueprose we designed a study protocol including two arms: ASCOT arm, were patients receive the stem cell mobilization treatment with Granulocyte colony stimulating factor (G-CSF) followed by apheresis and ovarian artery catheterism to selectively infuse the stem cells into the ovary and the G-CSF arm including patients that receive the mobilization treatment but not the ovarian artery catheterism to selectively infuse the cells into the ovary.

NCT ID: NCT03443297 Not yet recruiting - Preterm Infant Clinical Trials

Early Versus Delayed Feeding in Preterm Growth-Restricted Infants

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The introduction of enteral feeds for preterm, growth restricted infants are often delayed due to concern that early introduction may not be tolerated and may increase the risk of necrotizing enterocolitis. However, prolonged enteral fasting may diminish the functional adaptation of the immature gastrointestinal tract and extend the need for parenteral nutrition with its attendant infectious and metabolic risks. Early introduction of small volumes of milk in the form of Trophic feeding, promote intestinal maturation, may enhance feeding tolerance and decrease the time taken to reach full enteral feeding independently of parenteral nutrition. A Randomized Trial will be carried out over a period of 12 months in Department of Neonatology of BSMMU. Sample size will be 50(25 in each group). Infants with gestation below 35 weeks, birth weight below the 10th percentile for gestational age, will be randomly allocated by web-based randomization to commence enteral feeds "early," whose feeding will be started from 24 to 48 hours of age or "late," whose feeding will be started from 48 to 72 hours of age. Gradually feeding will be increased. Rate of advancement of feeding will be same for both groups. Primary outcomes will be time to achieve full enteral feeding sustained for 72 hours. Statistical analyses will be performed by using Fisher Exact test and by Student's t test for categorical data and quantitative data respectively. Logistic regression analyses will be performed to determine the role of independent variable.

NCT ID: NCT03418311 Not yet recruiting - Preterm Birth Clinical Trials

Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome

Impetus
Start date: September 2020
Phase: N/A
Study type: Interventional

Preterm birth (PTB) complicates 13% of all pregnancies worldwide and is the most important cause of neonatal morbidity and mortality. Women with a twin pregnancy are at increased risk of preterm delivery. In the Netherlands, approximately 50% of women with a multiple pregnancy deliver before 37 weeks of gestation (WoG), of whom 9% deliver before 32 weeks. Evidence based treatment guidelines concerning prevention of PTB are not available in Europe. Expectant management is usual care with interventions only in terms of a tertiary prevention of PTB according to guidelines for premature rupture of membranes, premature labour or other pregnancy complications. The studies done on this topic included women at different stages of the second trimester so the question of the onset of cervix shortening and its impact on PTB is not answered yet. The critical period for a maximum impact of the pessary treatment on PTB is still to be verified. Up to now only the ProTwinTrial addressed the long-term outcome of the newborns, so here data and evidence is clearly missing. The investigators want to assess the impact of a cervical pessary treatment in twin pregnancies with cervical shortening on children's survival without neurodevelopmental disability at the age of 3 years at 3 different stages of the second trimester (16-20 (early) vs. 20-24 (middle) vs. 24-28 (late) weeks of gestation).

NCT ID: NCT03418012 Not yet recruiting - Preterm Birth Clinical Trials

Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB

Prometheus
Start date: September 2020
Phase: N/A
Study type: Interventional

Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at delivery. Consequently every week of prolonged pregnancy will have a tremendous effect concerning the outcome of the new-borns, subsequently for their parents and society as well. The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the prevention of preterm birth in women with a singleton pregnancy who are at high risk of spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery and/or a history of previous cervical surgery. In accordance with the results by "van´t Hooft et al. 2016" an approximately 20% higher percentage of children's long-term survival without neurodevelopmental disability is expected for the pessary group in comparison with usual management (=control group) on basis of a reduction of prematurity < 34 week of gestation (WoG). The primary outcome measure for the effect of the pessary treatment in comparison to expectant management will be the children's long-term survival (3yrs) without neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary placement on the prevention of preterm birth and its resulting risk on mortality and morbidity for the neonates.

NCT ID: NCT03412487 Not yet recruiting - Clinical trials for Premature Ovarian Failure

Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure

Start date: January 2018
Phase: N/A
Study type: Interventional

25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group). *Pelvic laparoscopy and ovarian biopsy will be done ovarian biopsy preparation For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody

NCT ID: NCT03214744 Not yet recruiting - Preterm Infant Clinical Trials

Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants

pretermfood
Start date: May 2018
Phase: N/A
Study type: Observational

Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants

NCT ID: NCT03207412 Not yet recruiting - Clinical trials for Premature Ovarian Failure

Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency

Start date: December 22, 2017
Phase: N/A
Study type: Interventional

This project will investigate the safety and effectiveness of human amniotic epithelial cells in primary ovarian insufficiency patients and provide a new cell therapy against infertility.

NCT ID: NCT03177746 Not yet recruiting - Clinical trials for Erectile Dysfunction

The Safety of Dapoxetine/Tadalafil Combination Therapy

Start date: December 31, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of Dapoxetine/Tadalafil 30/20 mg film-coated tablet in the treatment of men with premature ejaculation and erectile dysfunction.

NCT ID: NCT03151122 Not yet recruiting - Preterm Infant Clinical Trials

The Effect of a Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The objective of the study is to establish a continuous nurse-led integrated support program and to exam its impact on preterm infant neurodevelopment. Research hypotheses include:1. The continuous nurse-led integrated support will have significant impact on preterm infant neurodevelopment; 2.The support program will also have positive effect on parent psychological well-being.