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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating whether early plasma transfusion from donors who recently recovered from Chikungunya infection can help newborns, whose mothers had peripartum Chikungunya infection, survive without developing encephalitis or encephalopathy (EE) in the first five days of life. This study aims to compare outcomes with a group of newborns who did not receive this treatment due to delayed diagnosis, transfer, or parental refusal. The trial focuses on newborns whose mothers had clinical or laboratory-confirmed Chikungunya infection around the time of birth. In the treatment group, newborns will receive a plasma transfusion called PC-CHIK-V derived from donors with recent Chikungunya infection. The timing of transfusion depends on when the maternal infection was diagnosed, with treatment given within 12 hours after birth or diagnosis. The trial includes newborns hospitalized in specialized neonatal units in Mayotte or La Réunion. An observational group of untreated newborns will be monitored as part of routine care for comparison. Participants will have daily clinic visits and biological tests until day 7, followed by one visit between 1 and 3 months of age. Researchers will evaluate the effectiveness of early PC-CHIK-V transfusion in preventing neonatal encephalitis or encephalopathy. Biological data from both treated and observational groups will be collected from maternal diagnosis through the newborn's first three months to assess safety and outcomes.

Age: 0Days - 2DaysAll GendersPhase Not Applicable
2 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating automated fetal heart functional parameters in healthy babies compared to those affected by congenital heart disease (CHD). This international multicenter prospective observational cohort study, with a nested case-control design, aims to determine if significant differences exist between the two groups and whether these parameters can improve the predictive value of the cardiovascular profile score for predicting hydrops. Participants will undergo assessments at two gestational age ranges: between 27+6 and 29+6 weeks and between 34+6 and 36+6 weeks. During the study, participants will receive two fetal cardiac function ultrasound examinations using either a clinical or research ultrasound system. The exams will measure various fetal biometric and cardiac function parameters, including Doppler indices, cardiac morphometry, valve function, and blood flow evaluations. Data will be collected and stored securely, with images analyzed using automated algorithms to assess cardiac function measurements such as pulsed wave Doppler myocardial performance indices and spatio-temporal image correlation annular plane systolic excursions. Participants will be followed until delivery and discharge of both mother and newborn. Researchers will collect anonymized information on pregnancy history, current pregnancy observations, delivery type, and maternal and neonatal conditions. The primary outcomes focus on comparing automated fetal cardiac parameters between CHD and control groups at specified gestational ages. Safety monitoring includes standard ultrasound scanning protocols, and data will be stored for at least five years after publication.

Age: 18Years +FEMALE
7 locations
Mamoudzou Clinical Trials | DecenTrialz