[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07216365":3,"trial-entities:NCT07216365":127,"trial-summary:NCT07216365":132},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":92,"sex":93,"minimum_age":94,"maximum_age":95,"healthy_volunteers":96,"eligibility_criteria":97,"std_ages":103,"locations":105,"central_contacts":121,"overall_officials":124,"references":125,"see_also_links":126},"NCT07216365","STUDY00011029","Caffeine Optimization for Oxygen Saturation Index in ELBW Infants","Caffeine Optimization for Oxygen Saturation Index in ELBW Infants (COFIE Trial)","RECRUITING","2029-09-01","2026-07","2026-07-29","2026-07-15","University of Rochester","OTHER",true,"The goal of this clinical trial is to determine whether a higher dose of caffeine citrate can improve breathing and reduce health complications in extremely premature infants, specifically those born before 28 weeks of pregnancy, known as ELGAN infants. These babies often struggle with breathing due to underdeveloped lungs, and caffeine is commonly used to help support their respiratory function. However, the most effective and safest dose has not yet been clearly established.\n\nThe study aims to answer two main questions: Does a higher maintenance dose of caffeine (10 mg\u002Fkg) lead to better oxygenation, as measured by the Oxygen Saturation Index (OSI), compared to the standard dose (5 mg\u002Fkg)? And does the higher dose reduce the risk of serious complications such as lung disease, brain injury, or death-without causing more side effects like fast heart rate, high blood pressure, or poor growth?\n\nTo answer these questions, researchers will compare two groups of infants: one receiving the high-dose caffeine treatment and the other receiving the standard dose. This comparison will help determine if the higher dose leads to better outcomes without increased risk.\n\nParticipants will begin caffeine treatment once they have regained their birth weight and are at least seven days old. They will be randomly assigned to receive either the high or standard caffeine dose and will be followed until caffeine is stopped or they are discharged from the hospital. During this time, researchers will monitor each infant's oxygenation levels, need for breathing support, signs of common complications, growth and feeding progress, and any side effects. Before discharge, each infant's motor development will also be assessed using a tool called the Test of Infant Motor Performance (TIMP).\n\nThis study could help define the most effective caffeine dosing strategy for supporting extremely premature infants and improving their short-term health outcomes.",null,[19,20],"Neonatal Apnea","Infants",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},40,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Caffeine Citrate","High Dose Group:\n\nCaffeine citrate administered as a 20 mg\u002Fkg loading dose followed by a 10 mg\u002Fkg\u002Fday maintenance dose starting at 7 days of life. Dose escalation up to 12.5 mg\u002Fkg\u002Fday may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion.\n\nStandard Dose Group:\n\nCaffeine citrate administered as a 20 mg\u002Fkg loading dose followed by a 5 mg\u002Fkg\u002Fday maintenance dose starting at 7 days of life. Dose escalation up to 7.5 mg\u002Fkg\u002Fday may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion.",[35,36],"High Dose Caffeine Arm","Standard Dose Caffeine Arm",[38,42,46,49,52,56,59,63,67,70,73,76,79,82,86,89],{"measure":39,"description":40,"timeFrame":41},"Average Oxygen Saturation Index (OSI) per Patient Over First 56 Days","The OSI is calculated as (FiO₂ × MAP × 100) \u002F SpO₂. The average OSI per patient will be calculated from randomization through the first 56 days or until caffeine is discontinued or the patient is discharged. Higher OSI values indicate worse oxygenation.","From Randomization to Day 56 or Caffeine Discontinuation",{"measure":43,"description":44,"timeFrame":45},"Total Duration of Respiratory Support","Total number of days each patient receives any respiratory support, including invasive ventilation, CPAP, or supplemental oxygen.","From Randomization to 1 year",{"measure":47,"description":48,"timeFrame":45},"Total Incidence of Severe Bronchopulmonary Dysplasia (BPD)","Number of infants diagnosed with severe BPD based on NICHD criteria.",{"measure":50,"description":51,"timeFrame":45},"Total Incidence of Severe Intraventricular Hemorrhage or Periventricular Leukomalacia (IVH\u002FPVL)","Number of infants diagnosed with severe IVH (Grade III\u002FIV) or PVL based on cranial imaging.",{"measure":53,"description":54,"timeFrame":55},"Total Length of NICU Stay","Total number of days each infant remains in the NICU from birth until discharge.","Birth to 1 year",{"measure":57,"description":58,"timeFrame":45},"Total Number of Infant Deaths","Number of infants who die before NICU discharge.",{"measure":60,"description":61,"timeFrame":62},"Total Test of Infant Motor Performance (TIMP) Score Prior to Discharge","TIMP is a 42-item motor development assessment. Each item scores from 0 to 6. Total scores range from 0 to 252. Higher scores indicate better motor performance.","Prior to NICU Discharge",{"measure":64,"description":65,"timeFrame":66},"Total Duration of SpO₂ Below Threshold (Intermittent Hypoxia)","Cumulative minutes with SpO₂ below target threshold, derived from Neo-DReAMS repository.","From Randomization through Day 56",{"measure":68,"description":69,"timeFrame":45},"Total Time with Heart Rate >180 bpm (Tachycardia)","Total minutes with heart rate exceeding 180 bpm recorded via monitor.",{"measure":71,"description":72,"timeFrame":45},"Total Growth Parameter Z-Scores (Length, Weight, Head Circumference)","Growth will be assessed using Fenton z-scores. Higher scores reflect better growth relative to gestational norms.",{"measure":74,"description":75,"timeFrame":45},"Total Osteopenia Markers (Alkaline Phosphatase, Calcium, Phosphorus)","Osteopenia assessed by abnormal lab values: alkaline phosphatase \\>500 IU\u002FL, abnormal calcium or phosphorus. Abnormal values per infant will be summed.",{"measure":77,"description":78,"timeFrame":45},"Total Incidence of Hypertension (>95th Percentile)","Number of days with blood pressure \\>95th percentile for gestational age.",{"measure":80,"description":81,"timeFrame":45},"Total Time to Full Enteral Feeds","Days from birth until the infant reaches 120 mL\u002Fkg\u002Fday enteral nutrition.",{"measure":83,"description":84,"timeFrame":85},"Total Number of NPO Periods >24 Hours","Number of times infant is NPO (nothing by mouth) for more than 24 hours.","From Randomization through NICU Discharge",{"measure":87,"description":88,"timeFrame":45},"Total Incidence of Necrotizing Enterocolitis (NEC)","Number of infants diagnosed with NEC (Bell's stage II or higher).",{"measure":90,"description":91,"timeFrame":45},"Total Incidence of Spontaneous Intestinal Perforation (SIP)","Number of infants with radiographically or surgically confirmed SIP.",[],"ALL","0 Days","27 Weeks",false,{"inclusion":98,"exclusion":100,"raw_text":102},[99],"URMC Inborn Newborn infants born with gestational age of 22 weeks 0 days - 27 weeks 6 days or infants OR ≥ 28 weeks with a birthweight \\\u003C 1000 grams",[101],"Hepatic failure, spontaneous intestinal perforation, necrotizing enterocolitis, Anticipated major congenital or genetic anomalies, infants not anticipated to survive beyond 72 hours, infants with mothers that are non-English speaking or \\\u003C18 years old at time of enrollment.","Inclusion Criteria:\n\n* URMC Inborn Newborn infants born with gestational age of 22 weeks 0 days - 27 weeks 6 days or infants OR ≥ 28 weeks with a birthweight \\\u003C 1000 grams\n\nExclusion Criteria:\n\n* Hepatic failure, spontaneous intestinal perforation, necrotizing enterocolitis, Anticipated major congenital or genetic anomalies, infants not anticipated to survive beyond 72 hours, infants with mothers that are non-English speaking or \\\u003C18 years old at time of enrollment.",[104],"CHILD",[106],{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":111,"contacts":112,"geoPoint":118},"University of Rochester Medical Center","Rochester","New York","14642","United States",[113],{"name":114,"role":115,"phone":116,"email":117},"Stephanie Vachon, DO","CONTACT","(585) 275-4174","stephanie_vachon@urmc.rochester.edu",{"lat":119,"lon":120},43.15478,-77.61556,[122],{"name":123,"role":115,"phone":116,"email":117},"Stephanie C Vachon, DO",[],[],[],{"nct_id":4,"conditions":128,"biomarkers":131},[129,130],"Apnea in newborn","Preterm Birth",[],{"nct_id":4,"found":15,"summary":133,"prompt_version":143},{"design":134,"status":135,"heading":136,"summary":137,"follow_up":138,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"This is an interventional study planning to enroll 40 extremely premature infants. It will compare a high dose of caffeine citrate to a standard dose.","completed","Caffeine Optimization for Oxygen Saturation in Premature Infants","This study is looking at whether a higher dose of caffeine citrate can help extremely premature infants (born before 28 weeks of pregnancy) breathe better and reduce health problems. These babies often have trouble breathing because their lungs are not fully developed. Caffeine is commonly used to help with breathing, but the best and safest dose isn't fully known. This study will compare a higher dose of caffeine citrate (10 mg\u002Fkg\u002Fday) to the standard dose to see if it improves how much oxygen babies get (measured by Oxygen Saturation Index or OSI). We are looking for 40 infants, aged 0 days to 27 weeks, who were born at URMC with a gestational age of 22 to 27 weeks, or those born at 28 weeks or more but weighing less than 1000 grams. The current status of the study is unclear.","Participants will be followed for their average Oxygen Saturation Index for the first 56 days, and for total duration of respiratory support and incidence of severe bronchopulmonary dysplasia (BPD) up to 1 year.",140,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]