[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06658496":3,"trial-entities:NCT06658496":101,"trial-summary:NCT06658496":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":17,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":42,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":74,"locations":76,"central_contacts":86,"overall_officials":95,"references":99,"see_also_links":100},"NCT06658496","2024-1052","PDA for Kidneys Study","Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study","RECRUITING","2027-05","2026-05","2026-05-15","2024-12-19","University of Wisconsin, Madison","OTHER",true,"The goal of this observational study is to gather more information on kidney oxygen levels in babies with a patent ductus arteriosus (PDA), and evaluate the relationships between kidney oxygen levels, PDA status and kidney injury.\n\nResearchers will do this by looking at ultrasound images of the heart, analyzing substances in the urine, and evaluating oxygen levels in the kidneys.",null,[19,20],"Patent Ductus Arteriosus","Congenital Heart Disease",[22],"neonate","OBSERVATIONAL",[],{"count":26,"type":27},45,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DEVICE","Near Infrared Spectroscopy","Application of regional NIRS sensors to brain and kidney sites in the first 72 hours after birth to monitor regional tissue oxygenation.",[34],"Neonates with PDA",[36],"NIRS",[38],{"measure":39,"description":40,"timeFrame":41},"Comparison of patent ductus arteriosus (PDA) echocardiography parameters to kidney hypoxia","Measured through continuous renal near infrared spectroscopy (NIRS) monitoring in neonates with a PDA to those without. Echos will be obtained every 48 hours during the first 7 days of age for a maximum of 3. RSO2 will be recorded until 7 days of age.","Days 1 to 7 of age",[43,47,51,55],{"measure":44,"description":45,"timeFrame":46},"Correlation of Iowa PDA score to kidney hypoxia","The Iowa PDA score will be classified as low (0-3), moderate (4-6), or high volume (\\>6) for each echo obtained. Lower scores are optimal. RSO2 correlation will be made with PDA score during the first 7 days of age.","Days 1-7 of age",{"measure":48,"description":49,"timeFrame":50},"Correlation between urinary biomarkers and Iowa PDA score","The Iowa PDA score will be classified as low (0-3), moderate (4-6), or high volume (\\>6). Urinary NGAL, cystatin C, and beta 2 micro globulin levels will be measured daily for the first 7 days of age and a correlation with the Iowa PDA score to levels of these biomarkers will be made.","Days 1-7 of life",{"measure":52,"description":53,"timeFrame":54},"Correlation between rates of hypertension and Iowa PDA score","The Iowa PDA score will be classified as low (0-3), moderate (4-6), or high volume (\\>6). Hypertension will be assessed for throughout hospitalization and a correlation with Iowa PDA score and the diagnosis of hypertension will be made.","Duration of hospitalization, up to 6 months",{"measure":56,"description":57,"timeFrame":54},"Correlation between rates of acute kidney injury (AKI) and Iowa PDA score","The Iowa PDA score will be classified as low (0-3), moderate (4-6), or high volume (\\>6). The diagnosis of AKI will be made using either or both urine output criteria or serum creatinine criteria and a correlation will be made with the IOWA PDA score in the first 7 days of age.","ALL","1 Minute","7 Days",false,{"inclusion":63,"exclusion":68,"raw_text":73},[64,65,66,67],"Delivered at \\\u003C32 weeks' gestation","≤72 hours of age","Inpatient at Meriter Hospital, Inc. NICU","At least one parent\u002Fguardian is able to provide parental permission in English or Spanish",[69,70,71,72],"Major congenital anomalies of kidney","Attending physician's discretion to not place NIRS sensors due to clinical concerns","In the PI or Co-I's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life","Birth parent aged \\\u003C18","Inclusion Criteria:\n\n* Delivered at \\\u003C32 weeks' gestation\n* ≤72 hours of age\n* Inpatient at Meriter Hospital, Inc. NICU\n* At least one parent\u002Fguardian is able to provide parental permission in English or Spanish\n\nExclusion Criteria:\n\n* Major congenital anomalies of kidney\n* Attending physician's discretion to not place NIRS sensors due to clinical concerns\n* In the PI or Co-I's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life\n* Birth parent aged \\\u003C18",[75],"CHILD",[77],{"facility":78,"status":8,"city":79,"state":80,"zip":81,"country":82,"geoPoint":83},"Meriter Hospital, Inc.","Madison","Wisconsin","53715","United States",{"lat":84,"lon":85},43.07305,-89.40123,[87,92],{"name":88,"role":89,"phone":90,"email":91},"Paige Condit, MD","CONTACT","616-481-9914","pcondit@wisc.edu",{"name":93,"role":89,"email":94},"Meg Baker","meg.baker@wisc.edu",[96],{"name":97,"affiliation":13,"role":98},"Matthew Harer, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":102,"biomarkers":103},[20,19],[],{"nct_id":4,"found":15,"summary":105,"prompt_version":114},{"design":106,"status":107,"heading":6,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an observational study with a planned enrollment of 45 participants. It is not a randomized or blinded study.","completed","This observational study, called the PDA for Kidneys Study, aims to learn more about how oxygen levels in a baby's kidneys are related to a condition called patent ductus arteriosus (PDA) and potential kidney injury. Researchers will use a device called Near Infrared Spectroscopy (NIRS) to monitor oxygen levels in the brain and kidneys of newborns during their first 72 hours of life. They will also look at heart ultrasounds and analyze urine samples. The main goal is to compare PDA heart measurements with kidney oxygen levels during the first week after birth. This study is for babies born before 32 weeks' gestation, who are 72 hours old or less, and are inpatients at Meriter Hospital, Inc. NICU. At least one parent must be able to give permission in English or Spanish. The study is currently unclear on its recruitment status.","The primary endpoint measures kidney hypoxia up to Day 7 of age.",141,"Participants will have Near Infrared Spectroscopy (NIRS) sensors applied to their brain and kidney sites during the first 72 hours after birth to monitor regional tissue oxygenation.","Not stated in the trial record.",[31],"v2"]