[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PENTA Foundation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":113},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100515587","optimising-kangaroo-care-to-reduce-neonatal-severe-infectionsepsis-and-resistant-bacterial-colonisation-among-high-risk-infants-in-nicu-100515587",false,"NCT05993442","Optimising Kangaroo Care to Reduce Neonatal Severe Infection\u002FSepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.","Optimising Kangaroo Care to Reduce Neonatal Severe Infection\u002FSepsis and Resistant Bacterial Colonisation Among High-risk Infants in Neonatal Intensive Care: a Pragmatic, Multicentre, Parallel Cluster Randomised Hybrid Implementation-effectiveness Study.","NeoDeco","INCLUSION CRITERIA\n\n1\\. Site level\n\n1a. Neonatal unit that provide routinely cares for extremely premature infants (\\\u003C28 weeks' gestation).\n\n1b. Minimum capacity of 12 beds.\n\n1c. Access to a -70 to -80°C freezer for storage of research samples\n\n1d. Willing to implement optimised KC if allocated to the intervention group.\n\n1e. Willing to commit to offering the minimum expected target duration or an increase of 50% if neonatal unit is already offering \\>67% of the minimum expected target duration, if allocated to the intervention arm.\n\n1f. Prepared to implement NeoIPC surveillance.\n\n1. g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.\n2. Infant level\n\n2a. All high-risk infants (born at \\\u003C32 weeks' gestation) admitted to participating neonatal units, regardless of complexity of care, anticipated hospitalisation duration, room type, or whether admitted directly after birth.\n\nEXCLUSION CRITERIA 1 Site level\n\n1. a. Participation in other research that could directly influence the study intervention or outcomes.\n2. a. Average StSC duration already exceeding 18 hours per day.\n3. a. Anticipated major changes in resistant bacterial colonisation pressure during the study\n\n2 Infant level 2a. No infant-level exclusion criteria for data collection. We exclude infants from individual data and sample collection if their parents or legal guardians do not provide written informed consent. These infants contribute to cluster-aggregated outcomes.","ALL","32 Weeks",{"count":20,"type":21},3080,"ESTIMATED","INTERVENTIONAL",[24],"NA","NeoDeco is a pragmatic, multicenter, parallel-group, cluster-randomised hybrid effectiveness-implementation trial designed to evaluate the impact of implementing optimised Kangaroo Care (KC) at the unit level compared to standard care in high-technology neonatal units. The trial includes a baseline period, a wash-in phase, and a staggered randomisation approach. The primary focus of the NeoDeco study is on high-risk preterm infants born at less than 32 weeks' gestational age, a population particularly vulnerable to hospital-acquired infections and sepsis during their initial hospital stay. By investigating hospital-acquired infections specifically, the study targets the period during which optimised KC practices are likely to have the most significant impact.",[27,28],"Infection, Bacterial","Infection Prevention",[30,31,32,33,34,35,36,37,38,39,40,41],"Nosocomial Infection","Prevention","Cluster","Implementation science","Surveillance","Kangaroo Care","Skin to Skin Contact","Neonatal Intensive Care Unit","NICU","Neonatal severe infection","Resistant bacterial","Pre-term infants","RECRUITING","2026-03-20",{"date":45,"type":46},"2026-03-25","ACTUAL",{"date":48,"type":46},"2024-05-28",{"date":50,"type":21},"2026-05",{"name":52,"class":53},"PENTA Foundation","NETWORK",24,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100583231","phase-2-safety-pharmacokinetics-and-antiviral-activity-of-remdesivir-veklury-in-hospitalized-children-with-rsv-100583231","NCT06873633","Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV","A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir (VEKLURY®) in Hospitalized Children Aged 0 to Less Than 2 Years With Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.","THAI-CARES RSV","Inclusion Criteria:\n\n* Signed informed consent from parents\u002Fcaregivers\n* Aged 0 to \\\u003C2 years\n* Weighing at least 2.0 kg\n* Onset of RSV associated-symptoms within 1 week of screening\n* Confirmed\\* with RSV infection (by rapid antigen test or RT PCR)\n* Hospitalized children fulfilling at least two of the following three RSV disease severity criteria:\n\n  * Inadequate oral feeding\n  * Inadequate oxygen saturation (peripheral capillary oxygen saturation \\[SpO2\\] \\\u003C95% on room air or requiring oxygen supplementation to maintain SpO2 ≥95%)\n  * Signs of respiratory distress (respiratory rate of ≥60 breaths per min for children aged up to 1 year, or ≥40 breaths per min for those older than 1 year, or accessory respiratory muscles use \\[subcostal, intercostal, or suprasternal retraction\\], or both)\n\nExclusion Criteria:\n\n* Preterm infants (gestational age at birth less than 37 weeks) who are aged \\\u003C56 days\n* Being hospitalized for other clinically relevant concurrent conditions (except for risk factors for severe RSV, e.g., cardiac disease, pulmonary disease, genetic disease, and prematurity)\n* Concurrent treatments with other agents with actual or possible direct antiviral activity against RSV \\\u003C24 hours prior to study drug dosing (e.g. ribavirin)\n* ALT or AST \\> 5 × ULN\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2 using the Schwartz formula if aged ≥1 year; or if aged \\\u003C1 year based on a creatinine value cut off dependent on chronological age\n* Any major congenital renal anomaly if \\\u003C28 days\n* Apgar score \\\u003C 5 when last recorded if age \\\u003C24 hours\n* Known hypersensitivity to the study drug, the metabolites, or formulation excipient.\n* On renal replacement therapies (e.g., intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy)\n* Any condition that, in the opinion of the site investigator, would make participation in the study unsafe for the child, or comprise the study objectives","0 Days","2 Years",{"count":66,"type":21},120,[68],"PHASE2","THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir (VEKLURY®) in children under two years of age who are hospitalized with confirmed respiratory syncytial virus (RSV) infection, as determined by either a rapid antigen test or RT-PCR. The primary objectives include evaluating the treatment's safety profile, its ability to significantly reduce RSV replication, and its overall acceptance in this patient population.",[71],"Respiratory Syncytial Virus (RSV)",[73,74,75],"respiration disorders","RSV infection","Respiratory Syncytial Virus Hospitalizations","2025-07-18",{"date":78,"type":46},"2025-07-23",{"date":80,"type":46},"2025-07-16",{"date":82,"type":21},"2027-02",{"name":52,"class":53},8,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100596110","phase-3-pregnancy-and-infant-preparedness-platform-in-europe-rsv-international-adaptive-platform-trial-to-evaluate-two-approved-prevention-options-to-prevent-respiratory-syncytial-virus-in-infants-maternal-vaccine-to-women-in-pregnancy-and-monoclonal-antibody-to-the-infants-given-alone-or-in-combination-100596110","NCT07041190","Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination.","PIPELINE-RSV International Trial. Pregnancy and Infant PrEparedness pLatform IN Europe (PIPELINE)- RSV International Immunisation Adaptive Platform Trial.","PIPELINE-RSV","Inclusion Criteria:\n\n* Pregnant women\n\n  * Pregnant woman #\n  * Provide informed consent prior to study enrolment\n  * Willing and able (in the Site Investigator's opinion) to comply with all study requirements\n  * Above the national legal age of consent\n  * Between 24+0 (or later as per national guidance) and 36+6 weeks gestation\n  * Able to read and complete the eHealth questionnaire in a language in which it is available\n  * Willing to receive MV in pregnancy, if allocated\n  * Willing for the baby to receive infant mAb, if allocated\n\nInfant\n\n* Informed consent provided by the mother, and other infant legal representative (partner \u002F co-parent) or legal guardian(s) if required by local regulations\n* Live-birth to mother enrolled in the study\n\n  * Inclusive of pregnant person of any\u002Fno gender\n\nExclusion Criteria:\n\nPregnant women\n\n* Major illness of the maternal participant or condition of the foetus that in the opinion of the Site Investigator would substantially increase the risk associated with the woman's participation in and completion of the study\n* Any suspected or confirmed condition in the foetus that in the opinion of the Site Investigator would contraindicate participation of the infant in the study\n* High risk of prematurity as judged by treating clinician\n* Multiple pregnancy (i.e. twins, triplets or more)\n* Previous participation in the PIPELINE-RSV trial\n* Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial\n* Any contraindication for receipt of intramuscular injection (bleeding diathesis or a condition associated with prolonged bleeding) or of vaccine (history of severe allergic reaction, e.g., anaphylaxis, to any component of the vaccine)\n* History of Guillain Barre Syndrome\n\nNote, all live born infants to mothers participating in the study will be included (with consent as required), but infant mAb will not be given if contraindicated.",true,{"count":95,"type":21},1500,[97],"PHASE3","RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get better by themselves but babies and younger children can become very poorly. About 1 in 15 infants with confirmed RSV within the first 12 months of life will be hospitalised, and a very small proportion will be seriously ill and may die.\n\nCurrently there are two different prevention options that can be used to prevent RSV infection in babies. One is a vaccine given to the mother during pregnancy, and the other is a monoclonal antibody given by injection to the baby. Although both prevention options work well on their own and are safe, neither provides 100% protection to the infant. It is not known whether giving both medicines, one to the mother in pregnancy and one to the infant, would provide better protection than giving only one medicine - this is what the PIPELINE-RSV study will look at.\n\nPIPELINE-RSV-International will recruit about 1500 pregnant women from across Europe in UK, Switzerland, the Netherlands and Belgium. A parallel trial, PIPELINE-RSV-France, running in France will recruit about 1000 pregnant women in France; the protocols will align on key aspects and the data will be analysed together. The study will include three study groups with different prevention options used in each: (1) a vaccine given to the mother in pregnancy, (2) an injection given to the baby at the beginning of RSV season, or (3) both a vaccine given to the mother in pregnancy and an injection given to the baby at around 4 months of age. Each mother-baby pair will be randomly allocated to group by a computer. The numbers of babies in each of these groups who acquire RSV will be compared. In some countries only two of the three study groups may be available.\n\nPregnant women and their babies will be followed until the baby reaches 12 months of age. Information will be collected about medically-important side effects either the mother or the baby had from their medicine(s) and any symptoms of RSV the baby had. Visits with the mother and baby will occur at birth, and 4 and 12 months later; these will ideally be in-person at birth and at 12 months. The mother will complete questionnaires via a Web-based platform to report any non-routine in-person visits, once in pregnancy and after the baby is born twice a month or monthly (more often in the winter), to also report baby's symptoms, to report their trial experience when the baby is 4 and 12 months' old, and to provide their views on vaccination at birth, and when the baby is 4 and 12 months' old. If the baby develops symptoms that might be RSV, their mother or another caregiver will be asked to take a sample using a swab from the baby's nose or mouth, and to send it by post for testing to find out if the baby has RSV.\n\nAs well as the main research study, there are also some substudies. A questionnaire will be given to women who consent to take part, to find out their motivations for joining the study and how they prefer to receive information about taking part in studies. A small number of women will be asked to take part in a study to look at how mothers' and babies' immune systems respond to the two different study prevention options , and to investigate different ways of collecting samples from their babies. In addition, researchers will use data from the study to see whether giving both medicines is cost-effective compared with giving just one medicine.\n\nThe study might be adapted in the future to look at other medicines for preventing RSV infection, when they become available.",[100],"RSV Immunization",[102,103],"Pregnancy RSV Immunization","Infant RSV Immunization","NOT_YET_RECRUITING","2025-06-19",{"date":107,"type":46},"2025-06-27",{"date":109,"type":21},"2025-09",{"date":111,"type":21},"2028-12",{"name":52,"class":53},""]