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Premature Birth clinical trials

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NCT ID: NCT04542096 Recruiting - Respiratory Failure Clinical Trials

Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT

Start date: September 29, 2020
Phase:
Study type: Observational

Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a real time, radiation free, non-invasive and portable. Neonatal respiratory distress syndrome (RDS) is a respiratory disorder resulting from immaturity of the lung structure and lack of surfactant. It is one the most common conditions in premature infants. Many of these infants require either invasive or non-invasive respiratory support. The goal of the study is to investigate the dynamic changes in pulmonary aeration during assisted breathing in very low birthweight preterm infants using pulmonary electrical impedance tomography. Currently most widely used methods to assess respiratory lung function are either invasive and/or indirect (ABG, pulse oximetry, transcutaneous pCO2 measurement), lacks temporal resolution (lung ultrasound) or emit ionizing radiation (CT). EIT provides information on regional lung aeration without the aforementioned shortcomings.

NCT ID: NCT04540575 Recruiting - Preterm Birth Clinical Trials

Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants

ReDiMOM
Start date: December 3, 2020
Phase: N/A
Study type: Interventional

In the US, the burden of very low birth weight (VLBW; <1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW infants. This disparity is amplified because black VLBW infants are significantly less likely to receive mother's own milk (MOM) feedings from birth until neonatal intensive care unit (NICU) discharge than nonblack infants, which adds to the lifelong burden of VLBW birth with increased risk of morbidities and greater costs. Pumping is associated with out-of-pocket and opportunity costs that are borne by mothers, unlike donor human milk and formula, which are paid for by NICUs. This innovative trial will determine the effectiveness of the intervention in reducing the disparity in MOM feedings and provide an economic analysis of the interventions, yielding critical data impacting generalizability and likelihood of implementation of results. The investigators hypothesize that mothers who receive intervention will have greater pumping volume and duration and their infants will be more likely to receive MOM at NICU discharge compared to mothers who receive standard of care lactation care and their infants.

NCT ID: NCT04531566 Recruiting - Premature Birth Clinical Trials

Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support

Start date: October 20, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate that allowing infants that require high flow nasal cannula (HFNC)/Continuous positive airway pressure (CPAP) to orally feed if demonstrating oral cues will achieve full oral feeds faster.

NCT ID: NCT04528251 Recruiting - Neonatal Sepsis Clinical Trials

Comparison of the Effectiveness of Two Different Antibiotic Regimens of the Treatment of Pregnant Women With Preterm Rupture of Membranes

Start date: September 1, 2020
Phase:
Study type: Observational

There is no consensus around the world on the treatment of preterm rupture of membranes, which is one of the important causes of early neonatal sepsis and one of the common causes of prematurity. Different countries, hospitals and physicians can determine different treatment approaches. There is very little scientific data on the benefit of commonly used treatment regimens other than experience. In this study, scientific results will be obtained by comparing the efficacy of treatments (Sulbactam ampicillin or azithromycin ampicillin) in two different hospitals (Hacettepe University Perinatology Clinic and Ankara City Hospital Perinatology Clinic), and it will be shown which treatment regimen reduces early neonatal sepsis and inflammation better. Some samples (vaginal IL-6, vaginal-cervical swab samples for atypical bacteria, cervical swab samples for direct microscopy, serum IL-6) will be taken from pregnant women who develop membrane rupture and these samples will be used as initial inflammation markers. Each physician will decide on the treatment of his own patient, there will be no intervention in the treatment of the patient within the scope of the research. Patients will continue their routine follow-up after receiving their treatment. When the delivery occurs, the level of IL-6 in the cord blood will be examined with other inflammation markers (procalcitonin, crp, complete blood count), and the neonatal inflammation status of the baby will be determined. The low inflammation markers detected in the babies of pregnant women with high initial inflammation values will be compared and it will be determined which treatment is more effective. At the same time, routine neonatal intensive care follow-ups of these babies will be continued and treatment efficiency in terms of early neonatal sepsis will be determined. This study will present scientific data on which treatment is effective in the literature and will guide international treatment guidelines. At the same time, preterm rupture of membranes will show which bacterial agent plays a more role in the etiology and which of the inflammation markers have more sensitivity and specificity, as well as the success of the treatment, which is the subject of the study. The routine use of some examinations (such as cervical PCR) performed before the treatment begins, is a guide in the selection of agent-specific treatment and may shorten the unnecessary drug use and hospital stay; The management of patients may vary according to the initial inflammation parameters. Physicians evaluating the results of this study can evaluate the risk of their babies in terms of early neonatal sepsis according to the initial inflammation values of their patients, and increase and decrease the length of hospital stay.

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: 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: 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.

NCT ID: NCT04458441 Recruiting - Pain, Acute Clinical Trials

Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies?

w-pi
Start date: May 5, 2020
Phase: N/A
Study type: Interventional

Peripheral central catheter application, especially in extremely low birth weight premature babies, is an intensive care follow-up procedure. There are many clinical studies in areas such as catheter type, skin disinfection, catheter duration, catheter infection. In our practice, it was observed that premature baby was less uncomfortable, the number of trials decreased, and the change in body temperature was less with the application of hot skin disinfection in our practice. With a prospective randomized study, the investigators wanted to document their observational data scientifically.

NCT ID: NCT04444206 Recruiting - Preterm Birth Clinical Trials

Prevention of Preterm Birth by Screening of the Consistency Index and Length of the Uterine Cervix in Women With a Single Pregnancy

PreBirthCerv
Start date: April 25, 2020
Phase: N/A
Study type: Interventional

Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB. Other strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix. However, the predictive value of the research has recently been questioned, as the threat rate from preterms in the low-risk population has not decreased over time. Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its complaints during the three trimesters of pregnancy, an evaluation of the cervical consistency index (CCI) was also proposed, i.e. an ultrasound evaluation of cervical softness.