View clinical trials related to Extreme Prematurity.
Filter by:TREOCAPA is a Phase II/III European Multicentre study concerning the prophylactic treatment by Acetaminophen of extremely preterm infant during the first five days after birth. The Phase II is a dose finding phase in order to assess the minimum effective dose regimen of acetaminophen for the closure of PDA for neonates with a gestational age less than 27 weeks This part of the study will be conducted in 11 NICUs, in 4 countries (France, UK, Finland and Denmark). The Phase III is The phase III is a randomized, multicenter, double-blind, placebo-controlled superiority trial, two arms in a 1:1 ratio, evaluating an increasing of 10% of the percentage of survival without severe morbidity at 36 weeks of post menstrual age. In the intervention arm, 20 mg/kg followed by 7.5 mg/kg quarter in die (QID) will be administered to the 27-28 weeks gestational age group (dosage confirmed through PK/PD data analysis from the previous Finnian study) and the dosage selected after the conclusion of the Phase II will be administered to the 23-26 weeks gestational age group. A group sequential design, with a total of 3 analyses (2 interim analyses and a final) and the O'Brien-Fleming alpha spending function is chosen for the trial. At the same time, a Bayesian sequential analysis is planned for safety endpoints
Extreme premature Children will at discharge from Karolinska Hospital and Södersjukhuset in Stockholm be asked to participate in a study, examining the effects of a home-visit based post-discharge program aiming at facilitating the interaction between infants and parents, improving the development of the children, and the parental mental health. The study is a randomized controlled Trial (RCT), hence 50% of the participants will be offered treatment as usual (TAU) with addition of an extended follow-up program. The interaction-based program consists of one initial visit at the hospital followed by nine home-visits and two telephone calls during the child's first year of life. The interventionists are skilled Healthcare professionals with several years of experience from caring for premature infants and their parents. All interventionists have successfully completed a one year further education program, delivered one day per week and containing theoretical lectures, practice with actual cases, supervision on the cases, visits to the different parts of the neonatal care chain and discussions with a representative from the premature family association Sweden.