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Premature Birth clinical trials

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NCT ID: NCT04519112 Not yet recruiting - Clinical trials for Premature Ventricular Contraction

Remote Magnetic Versus Manual Navigation-guided Ablation for Non-outflow Tract Premature Ventricular Contractions: a Prospective, Randomized, Controlled Trial

Start date: October 1, 2020
Phase: Phase 4
Study type: Interventional

This prospective, randomized, controlled trial is designed to compare the safety and efficacy of remote magnetic navigation-guided ablation for ventricular premature complexes arising from non-outflow tracts with manual control navigation.

NCT ID: NCT04516226 Recruiting - Clinical trials for Preterm Premature Rupture of Membrane

Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes

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

Randomized controlled trial studying the use of vaginal cleansing with chlorhexidine gluconate for pregnant women with PPROM (preterm pre labor rupture of membranes). The primary outcome will be pregnancy latency. Secondary outcomes will include various maternal and neonatal outcomes, and inflammatory markers from maternal blood, amniotic fluid, fetal cord blood and placental analysis.

NCT ID: NCT04515524 Enrolling by invitation - Clinical trials for Retinopathy of Prematurity

Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next)

Start date: February 16, 2021
Phase:
Study type: Observational

Primary objectives of the study are: - To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP). - To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP. Secondary objectives of the study are: - To describe visual function in patients included from the VGFTe-ROP-1920 study, for treatment of ROP. - To describe overall development in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.

NCT ID: NCT04509375 Recruiting - Clinical trials for Anemia of Prematurity

Near-Infrared Spectroscopy and Cranial Doppler in Premature Newborns With Anemia

Start date: March 14, 2019
Phase:
Study type: Observational

It is aimed in this study to examine the changes in brain blood supply and oxygenation in neonatal premature babies who have anemia and who underwent erythrocyte suspension transfusion in the light of original guidelines by means of obtaining measurements with the help of cranial doppler ultrasonography and near-infrared spectroscopy.

NCT ID: NCT04506619 Terminated - Clinical trials for Bronchopulmonary Dysplasia

Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants

Start date: September 9, 2020
Phase:
Study type: Observational

The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.

NCT ID: NCT04505176 Not yet recruiting - Premature Birth Clinical Trials

Comparison of the Results of Transcutaneous Carbon Dioxide and Oxygen Pressure in Premature Neonates Who Underwent MIST Under HHHFNC or Nasal CPAP Methods

TCOPHC
Start date: November 30, 2020
Phase:
Study type: Observational [Patient Registry]

Intratracheal surfactant treatment is applied in Respiratory Distress Syndrome (RDS) Continious Positive Airway Pressure(CPAP) treatment. In recent clinical studies, two similar methods have been studied with a thin catheter without endotracheal intubation in the application of surfactant. In our neonatal intensive care unit, respiratory support is given with nasal CPAP and Humidified Heated High Flow Nasal Cannula (HHHFNC) instead of classical invasive (intubated) mechanical ventilation methods. In CPAP method, heated and humidified air is given a certain pressure (6-8 cmH2O), while in HHHFNC method, heated humidified air is given at a certain flow rate (6-8 L / min). This study was planned to compare the results of infants who were given surfactant with MIST (Minimal Invazive Surfactant Treatment) method under CPAP or HHHFNC support in the treatment of respiratory distress syndrome in premature babies. During surfactant application, babies will be monitored (as in all babies in the NICU) saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary bed) and t values will be recorded. For all these reasons, monitoring of PI (Perfusion Index), PVI (plethysmographic variability index) and continuous transcutaneous PCO2 and PO2 values are of great importance for the prevention of mortality and morbidity, as well as monitoring of oxygen saturation values with pulse oximetry in premature babies. In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients will be consecutively distributed to two groups until they reach the specified number of patients. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support. At the end of the study, all data will be entered in an SPSS (Statistical Package for the Social Sciences) file and study statistics will be made. A database will be created using SPSS software. A p value of <0.05 was determined as the limit of significance.

NCT ID: NCT04499430 Active, not recruiting - Premature Birth Clinical Trials

Comparison of the Results of Premature Babies Started Complementary Feeding

COTROPBSCF
Start date: June 8, 2020
Phase:
Study type: Observational [Patient Registry]

Neurological-developmental evaluations and developmental outcomes-diagnoses of premature babies are evaluated according to corrected postnatal age. Based on the limited evidence available, it can be concluded that complementary feeding may be an appropriate age for most premature babies who have reached at least the third month, generally corrected. However, for premature babies born at different gestational weeks, these periods have a relatively different meaning. A more accurate timeframe can be found in terms of complementary nutrition by evaluating chronological age and motor development together. More prospective observational studies are needed in this regard in premature babies. In the literature, there are not enough studies on the transition time to the most appropriate complementary diet for premature babies. The investigators planned to do this prospective observational study. In this study, patient groups will be randomly selected after appropriate matching. Premature babies participating in the study will be handled in three main groups (six subgroups in total). The data will be added to the case report forms. In addition to routine follow-ups, families will be called on the phone monthly, information about their babies' nutrition will be asked, whether there is a problem, questions of families will be answered, and information about complementary nutrition will be provided. At the end of the study, all data will be collected and entered into the SPSS database, which will be created.

NCT ID: NCT04494529 Completed - Preterm Birth Clinical Trials

Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth

SNACS Pilot
Start date: March 1, 2021
Phase: Phase 3
Study type: Interventional

Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome, in preterm infants. Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity. We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg) of betamethasone. The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we have received funding from the Canadian Institutes of Health Research (CIHR).

NCT ID: NCT04489056 Recruiting - Vaginal Microbiome Clinical Trials

Microbiome in Preterm Birth

Start date: July 27, 2020
Phase:
Study type: Observational

The aims of this prospective longitudinal case-control pilot-study are (1) to characterize the changes of the vaginal, uterine and placental microbiome in pregnant women experiencing pPROM with immediate hospitalization and consecutive caesarean section at preterm, in comparison to uneventful term births with elective cesarean section, as well as (2) to evaluate the influence of the maternal on the neonatal microbiome and the early neonatal outcome in pPROM preterm cases, in comparison to uneventful term births. The first aim will be achieved by collecting vaginal and rectal swabs for microbiome analysis in women experiencing pPROM, followed by uterine and placental swabs that are collected during the caesarean section. Control samples will be collected at the same time points from women undergoing elective caesarean section at term. The second aim will be achieved by microbiome analysis of rectal, oral/buccal, and skin swabs taken from newborns that are either born preterm after pPROM, or at term, both by caesarean section.

NCT ID: NCT04483401 Recruiting - Premature Birth Clinical Trials

Premie DCD Imaging Intervention Study

Start date: May 26, 2016
Phase: N/A
Study type: Interventional

This study will leverage a current longitudinal study of brain development in preterm children. In the Miller/Grunau Trajectories study, preterm children are returning for follow-up at 8-9 years. At this appointment, children undergo MRI and neurodevelopmental testing. Children who are identified with DCD at this appointment will be invited to participate in this intervention study. Participants will have a 2nd MRI 12 weeks after the first scan. They will then receive 12 weekly sessions with an occupational therapist, followed by a third MRI. Children with DCD who were born very preterm (<32 weeks gestational age) who are not part of the Miller/Grunau study are also eligible to participate.