[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute of Mother and Child, Warsaw, Poland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,79,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100628527","continuous-glucose-monitoring-in-newborns-of-mothers-with-insulin-treated-gestational-diabetes-mellitus-100628527",false,"NCT07462793","COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus","COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial","COMET-GDM","Inclusion Criteria:\n\n* Maternal age of 18 years or older\n* Singleton pregnancy\n* Insulin-treated gestational diabetes mellitus\n\nExclusion Criteria:\n\n* Multifetal pregnancy\n* Congenital malformations or metabolic defects in the newborn\n* Preterm birth (defined as birth \\\u003C37 weeks of gestation)\n* Smoking during pregnancy\n* Preeclampsia, fetal growth restriction\n* Perinatal asphyxia\n* Congenital infections in the newborn\n* Adverse skin reactions (eczema, wounds) in the planned sensor insertion area",true,"ALL","1 Minute","30 Minutes",{"count":22,"type":23},120,"ESTIMATED","INTERVENTIONAL",[26],"NA","The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes.",[29,30],"Neonatal Hypoglycemia","Gestational Diabetes Mellitus (GDM)",[32,33,34,35],"gestational diabetes mellitus","neonatal hypoglycemia","insulin-treated gestational diabetes","neurodevelopmental outcomes","NOT_YET_RECRUITING","2026-03-08",{"date":39,"type":40},"2026-03-10","ACTUAL",{"date":42,"type":23},"2026-03",{"date":44,"type":23},"2027-12",{"name":46,"class":47},"Institute of Mother and Child, Warsaw, Poland","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":24,"phases":61,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100621468","fecal-microbiota-transplantation-in-children-with-autism-spectrum-disorder-and-gastrointestinal-symptoms-100621468","NCT07371013","Fecal Microbiota Transplantation in Children With Autism Spectrum Disorder and Gastrointestinal Symptoms","Fecal Microbiota Transplantation in Children With Autism Spectrum Disorder and Gastrointestinal Symptoms: A Pilot Study","FMT-ASD-GI","Inclusion Criteria:\n\n* Providing informed consent for participation in the study by the child's legal representative - parent or legal guardian.\n* Diagnosis of autism spectrum disorder according to DSM-5 or ICD-11 criteria.\n* Ability to swallow an empty test capsule identical in shape and size to the investigational product\n* Abnormal stool consistency observed by parents for at least 2 months prior to study inclusion.\n\nPatients with an average stool consistency greater than 5 on the Bristol Stool Form Scale (BSFS) during the baseline period will be classified as having diarrhea.\n\nPatients with an average stool consistency less than 3 on the Bristol Stool Form Scale during the baseline period will be classified as having constipation.\n\nExclusion Criteria:\n\n* Presence of a gastrointestinal disease such as celiac disease, food allergy, inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic esophagitis, peptic ulcer disease of the stomach or duodenum, Hirschsprung's disease.\n* Primary or secondary immunodeficiency, including absolute neutrophil count in peripheral blood \\\u003C1500 measured within 28 days prior to planned FMT.\n* History of surgery involving disruption of intestinal continuity within 3 months prior to study inclusion.\n* Lactose or fructose intolerance. Patients with lactose intolerance who follow an elimination diet and still experience symptoms may be included in the study.\n* Malnutrition defined as Body Mass Index (BMI) below the 3rd percentile based on Polish growth charts from 2010.\n* Overweight or obesity defined as BMI above the 85th percentile based on Polish growth charts from 2010.\n* Active infection requiring antibiotic therapy.\n* Expected use of antibiotics during participation in the study.\n* Use of probiotics during participation in the study.\n* Inability to undergo bowel cleansing therapy (Dicopeg Endo).\n* Inability to swallow an empty test capsule.\n* Lack of consent from the child's legal representative - parent or legal guardian - for participation in the study.","6 Years","12 Years",{"count":60,"type":23},20,[26],"The aim of the study is to evaluate the effectiveness and safety of fecal microbiota transplantation (FMT) in reducing gastrointestinal (GI) and behavioral symptoms in children with autism spectrum disorder (ASD).\n\nChildren with ASD often experience GI problems such as constipation, diarrhea, and abdominal pain. These symptoms can negatively affect their daily life and behavior. Recent research suggests that the gut microbiota-the community of bacteria and other microorganisms living in the intestines-plays an important role in digestion, immunity, and communication with the brain through the gut-brain axis. Modifying the gut microbiota may help improve GI symptoms and possibly behavioral functioning.\n\nFMT involves giving a preparation containing gut microbiota from a healthy donor after bowel cleansing. The product used in this study is MBiotix HBI Caps, produced by Human Biome Institute. A placebo (inactive substance) will also be used for comparison. Both will be given as frozen oral capsules that look identical.\n\n20 children aged 6-12 years will take part. Participants will be randomly assigned to receive either the microbiota preparation or placebo. The study includes several visits over about 6 months. Before the first dose, every child will undergo bowel cleansing with a special preparation (Polyethylene Glycol, PEG). During the study, participants will be asked to keep a symptom diary, complete questionnaires, and record child's diet. Biological samples (stool, urine, saliva) will be collected at specific time points for analysis. Every child will also be assessed by a psychologist before the study begins and again during the study using standardized tools (Autism Diagnostic Observation Schedule, Second Edition, ADOS-2) to evaluate behavioral functioning and quality of life.",[64,65],"Autism Spectrum Disorder","Gastrointestinal Symptoms",[67,68,69,70],"fmt","asd","gi","autism","2026-01-22",{"date":73,"type":40},"2026-01-27",{"date":75,"type":23},"2026-01",{"date":77,"type":23},"2027-03",{"name":46,"class":47},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":86,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":48},"100591747","cord-blood-s100b-protein-levels-in-neonates-following-intrauterine-transfusions-for-hdfn-associated-fetal-anemia-100591747","NCT06984445","Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia","Analysis of Cord Blood S100B Protein Levels in Neonates With Fetal Anemia Due to Hemolytic Disease Undergoing Intrauterine Transfusions: A Prospective Cohort Study","Study Group - Inclusion Criteria:\n\n1. Singleton pregnancy.\n2. Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.\n3. Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.\n4. Fetal anemia requiring IUT, indicated by a MCA-PSV MoM value exceeding 1.5.\n\nStudy Group - Exclusion Criteria:\n\n1\\. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).\n\nControl Group - Inclusion Criteria:\n\n1. Singleton pregnancy.\n2. Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.\n3. Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.\n4. No indications for IUT, as determined by MCA-PSV MoM values \\\u003C1.5 in routine assessments of fetal cerebral arterial flow.\n\nControl Group - Exclusion Criteria:\n\n1\\. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).","FEMALE","18 Years",{"count":89,"type":23},180,"OBSERVATIONAL","levated levels of S100B protein are a well-established marker of central nervous system (CNS) damage. Fetal anemia resulting from hemolytic disease of the fetus and newborn (HDFN) often necessitates intrauterine transfusions (IUTs) and represents a significant risk factor for CNS injury. However, it remains uncertain whether S100B protein levels can reliably predict which fetuses are at higher risk for CNS complications in this context. Furthermore, the potential role of measuring S100B concentrations before IUT in prenatal assessments, and its relationship to the severity of anemia and fetal cerebral blood flow, remains poorly understood. This study aims to investigate the concentration of S100B protein in cord blood from newborns with HDFN-related fetal anemia requiring IUT. The study group comprises pregnancies complicated by HDFN with abnormal middle cerebral artery (MCA) blood flow, indicating the need for IUT. In this group, S100B protein levels will be measured before each IUT, with additional measurements if further transfusions are required. The control group consists of pregnancies with HDFN that do not require IUT. Cord blood samples will be collected at birth to evaluate S100B protein levels in both groups. Additionally, fetal MCA blood flow will be monitored, and in the study group, fetal hemoglobin and hematocrit levels will be assessed before each IUT. The primary endpoints of the study include the measurement of cord blood S100B protein levels before IUT in the study group and at birth in both groups. Secondary endpoints will explore the potential correlations between S100B protein levels and umbilical cord blood gas parameters (e.g., pH, BE, lactate), fetal cerebral blood flow parameters (e.g., MCA-PSV values), and blood count parameters (e.g., hemoglobin and hematocrit levels), both before IUT in the study group and after birth in both groups.",[93,94,95,96],"s100b","Hypoxia-Ischemia, Brain","Hemolytic Disease of the Fetus and Newborn","Fetal Anemia",[98,99,100,101,102,103,104],"S100B protein","hemolytic disease of fetus and newborn (HDFN)","intrauterine transfusion (IUT)","fetal anemia","newborn","central nervous system (CNS) damage","CNS hypoxia-ischemia (HI)","RECRUITING","2025-05-14",{"date":108,"type":40},"2025-05-22",{"date":110,"type":40},"2024-07-17",{"date":112,"type":23},"2026-04-30",{"name":46,"class":47},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":86,"minAge":87,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":48},"100584789","cord-blood-s100b-protein-concentration-in-neonates-with-fetal-growth-restriction-100584789","NCT06893926","Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction","Evaluating the Utility of S100B Protein Concentration for Diagnosing Fetal Central Nervous System Hypoxia-Ischemia in Children With Late Fetal Growth Retardation: A Prospective Cohort Study","Study Group - Inclusion Criteria:\n\n1. Women with a full-term pregnancy (≥37 weeks of gestation), singleton.\n2. Pregnancy complicated by FGR.\n\nStudy Group - Exclusion Criteria:\n\n1. Antenatal (at recruitment):\n\n   * Maternal conditions that may affect the blood flow in placental vessels, including smoking, use of illicit stimulant substances, or pregestational diabetes.\n   * Maternal depression requiring pharmacological treatment (e.g., SSRIs).\n2. Intrapartum:\n\n   * Factors indicating a possible intrauterine infection, such as amniotic fluid leakage for more than 15 hours, spontaneous preterm labor, diagnosed intrauterine infection, or symptoms of infection in the mother.\n   * Prolonged labor lasting more than 15 hours.\n\nControl Group - Inclusion Criteria:\n\n1. Women with a full-term pregnancy (≥37 weeks of gestation), singleton.\n2. Pregnancy not complicated by FGR.\n\nControl Group - Exclusion Criteria:\n\n1. Antenatal (at recruitment):\n\n   * Maternal conditions that may affect placental blood flow, such as smoking, use of illicit stimulant substances, pregestational diabetes, or chronic hypertension.\n   * Maternal depression requiring pharmacological treatment (e.g., SSRIs).\n   * Risk factors for intrauterine HI, including abnormal fetal blood flow parameters on ultrasound, abnormal CTG recordings, or the need for intrauterine transfusion.\n2. Intrapartum:\n\n   * Indicators of possible intrauterine infection, such as amniotic fluid leakage for more than 15 hours, spontaneous preterm delivery, diagnosed intrauterine infection, or maternal symptoms of infection.\n   * Risk factors for perinatal HI.\n   * Prolonged labor lasting more than 15 hours (counted from the onset of regular uterine contractions).\n   * Birth weight below the 10th percentile or above the 90th percentile.\n   * Apgar score less than 8 at the 1st, 3rd, 5th, or 10th minute of life.\n   * Abnormal umbilical cord blood gas analysis results, defined as pH \\\u003C 7.15 or BE \\\u003C -9.3 mmol\u002Fl.\n3. Postnatal:\n\n   * Neonatal anemia requiring a top-up transfusion within the first 24 hours of life",{"count":22,"type":23},"S100B protein is a biomarker that increases following central nervous system (CNS) damage. Measuring this protein's levels may allow for the early identification of infants at high risk for developmental abnormalities, such as fetal growth restriction (FGR), even on the first day of life, in a non-invasive manner. Early detection could enable timely interventions and rehabilitation, potentially improving the child's prognosis and long-term outcomes. This study investigates two groups of full-term pregnancies: a study group with prenatally diagnosed late FGR, and a control group with normal fetal growth. Following delivery, cord blood samples from both groups will be analyzed for S100B protein concentrations, pH, base excess (BE), and lactate levels. Additionally, fetal blood flow parameters in the umbilical artery (UA), uterine arteries (UtA), ductus venosus (DV), and middle cerebral artery (MCA) will be monitored via ultrasound within 48 hours before delivery. This study aims to compare S100B protein concentrations in umbilical cord blood between the two groups and to assess correlations with fetal Doppler parameters, pH, BE, and lactate levels in cord blood gas analysis. Ultimately, we seek to determine the effectiveness of S100B protein concentration as a biomarker for diagnosing fetal CNS hypoxia- ischemia in FGR-affected children, compared to those with normal growth.",[93,94,124],"Fetal Growth Restriction (FGR)",[98,126,102,103,104],"fetal growth restriction (FGR)","2025-03-24",{"date":129,"type":40},"2025-03-25",{"date":131,"type":40},"2024-06-18",{"date":133,"type":23},"2026-03-31",{"name":46,"class":47},""]