[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NICHD Global Network for Women's and Children's Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":118},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,90],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100581807","phase-3-caffeine-for-hypoxic-ischemic-encephalopathy-100581807",false,"NCT06855108","Caffeine for Hypoxic Ischemic Encephalopathy","Caffeine for Hypoxic Ischemic Encephalopathy (CHIME Trial)","CHIME","Participant Inclusion Criteria:\n\nInfants who meet all the following criteria are eligible for enrollment as study participants:\n\n1. Liveborn infants ≥36 weeks\n2. Birth weight ≥1800 grams\n3. Meets physiologic criteria for moderate to severe HIE, defined as meeting either of the following two criteria:\n\n   1. Criterion #1: Severe acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria:\n\n      * pH \\\u003C7.0; or\n      * Base Deficit ≥16 mmol\u002FL; or\n      * Lactate \\>8 mmol\u002FL.\n   2. Criterion #2: Participant must meet all of the following three criteria:\n\n   i. Moderate acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria:\n   * POC pH 7.0-7.15; or\n   * Base Deficit 10.0-15.9 mmol\u002FL; or\n   * Lactate 6-8 mmol\u002FL.\n\n   ii. Evidence of an acute perinatal event (i.e., placental abruption, intrapartum hemorrhage, cord prolapse, severe fetal heart rate abnormality, uterine rupture).\n\n   iii. Any of the following criteria:\n   * 10-minute Apgar \\\u003C5; or\n   * Need for assisted ventilation initiated at birth and continued for ≥10 minutes\n4. Meets neurologic criteria for moderate to severe HIE, defined as a physical exam conducted between one and six hours after birth that meets either of the following criteria:\n\n   1. Moderate to severe encephalopathy in at least three out of six modified Sarnat categories (level of consciousness, spontaneous activity, muscle tone, posture, primitive reflexes, autonomic function); or\n   2. A clinical diagnosis of seizure in the first six hours after birth.\n\nParticipant Exclusion Criteria:\n\nInfants who meet any of the following criteria are not eligible for enrollment as study participants:\n\n1. Home births\n2. Infants who cannot be enrolled, randomized and receive study medication within 6 hours post-delivery\n3. Infants with a recognized major congenital anomaly or genetic syndrome that would affect their neurodevelopment.\n4. Infants for whom medical care will not be provided based on the severity of their condition or any other condition that would preclude participation per clinical judgement.\n5. Infant has received therapeutic hypothermia or there is a clinical plan to initiate active or passive hypothermia for the infant.\n6. Infants who will be unavailable to complete follow-up visits.\n7. Infants who have received caffeine after delivery.\n8. Infants whom the health care team deem ineligible for the study based on likelihood to receive caffeine outside of the study protocol.\n9. Enrollment in another trial that will impact participation in this trial.","ALL","6 Hours",{"count":20,"type":21},830,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE). The trial will recruit neonates who are diagnosed with HIE within six hours after birth based on physiologic criteria (acidosis noted on an umbilical cord or early \\[\\\u003C1 hour\\] postnatal blood sample) and neurologic criteria (modified Sarnat exam consistent with encephalopathy). Following informed consent, and by six hours after birth, neonates with HIE will be randomized to one of two treatment arms and subsequently receive one 20 mg\u002Fkg dose of oral caffeine followed by two additional 10 mg\u002Fkg doses at 24-hour intervals or placebo of the same regimen (three total doses).\n\nThe goal of this clinical trial is to compare the incidence of all-cause mortality OR moderate to severe neurodevelopmental impairment (NDI) at 18-22 months between neonates with HIE who are randomized to oral caffeine or placebo. Our hypothesis is that neonates with HIE who receive oral caffeine will have 10% lower incidence of all-cause mortality or moderate to severe NDI at 18-22 months compared to placebo.",[27],"Hypoxic Ischemic Encephalopathy (HIE)",[29,30,31,32],"Caffeine","Hypoxic Ischemic Encephalopathy","HIE","AKI","RECRUITING","2026-06-19",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2026-04-08",{"date":41,"type":21},"2030-07",{"name":43,"class":44},"NICHD Global Network for Women's and Children's Health","NETWORK",7,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":45},"100571679","phase-3-asymptomatic-bacteriuria-in-pregnancy-in-low--and-middle-income-countries-100571679","NCT06723392","Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries","Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries: A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research","ABLE","Inclusion Criteria:\n\nIndividuals who meet the following criteria are eligible for randomization:\n\n* Enrolled in GN MNHR\n* Established pregnancy ≥12 and ≤20 weeks GA by last menstrual period and\u002For clinical assessment and\u002For ultrasonography\n* Age: 18 years (or lower limit age eligible\\*) to 49 years\n\n  \\* Some sites will be able to include individuals giving birth regardless of age if they are considered an adult or an emancipated minor. However, other sites will require individuals to be at least 18 years of age. The investigators will adhere to local regulations.\n* Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up\n* Able to provide informed consent\n* Presence of a single bacterial isolate (\\>105 colony forming unit (CFU)\u002FmL) in urine at enrollment\n* Intent to remain in study area for at least 42 days PP\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria are not eligible for randomization:\n\n* Gestational age \\\u003C12 weeks or \\>20 weeks\n* Received treatment with any antibiotic within 14 days before screening visit\n* Current symptoms of UTI\n* History of allergy to nitrofurantoin\n* Pregnancy loss \u002F miscarriage prior to randomization\n* Currently taking magnesium-containing antacid\n* Any illness \u002F condition (e.g., anemia, diabetes, renal disease, pulmonary disease) requiring immediate medical care per site PI assessment\n* Enrollment in another trial that per the study MOP will impact this trial",true,"FEMALE","18 Years","49 Years",{"count":59,"type":21},1134,[24],"This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 \\[End preventable deaths of newborns and children under 5 years of age\\] by examining the potential impact of this practice to reduce the incidence of SVN\u002FSB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).",[63,64,65,66],"Preterm Birth","Small for Gestational Age (SGA)","Stillbirth","Bacteriuria (Asymptomatic) in Pregnancy",[68,69,70,71,72,73,74,75,76,77,78,79,80,81],"asymptomatic bacteriuria","small vulnerable newborn","preterm birth","small for gestational agea","still birth","SVN\u002FSB","oral nitrofurantoin monohydrate\u002Fmacrocrystals","Global Network","Bangladesh","India","Pakistan","Democratic Republic of Congo","Zambia","Guatemala","2026-01-20",{"date":84,"type":37},"2026-01-22",{"date":86,"type":37},"2025-12-08",{"date":88,"type":21},"2028-11",{"name":43,"class":44},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":54,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100138497","maternal-newborn-health-registry-100138497","NCT01073475","Maternal Newborn Health Registry","Global Network for Women's and Children's Health Research Maternal Newborn Health Registry","MNH","Inclusion Criteria:\n\n* Community-level\n\n  * Appropriate for long-term registry data collection and the conduct of ongoing Global Network research\n  * At least 300 deliveries per year\n* Participant-level\n\n  * Pregnant women intending to deliver within study cluster\n  * Women who deliver within the study cluster\n  * Women who reside in the community but are transferred for care at delivery\n\nExclusion Criteria:\n\n* Participant-level\n\n  * Opt out of consent to include data in the study",{"count":99,"type":21},950000,"OBSERVATIONAL","The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths, neonatal and maternal mortality.",[103],"Pregnancy Outcome Trends in Low-resource Geographic Areas",[105,106,107,65,108,109],"Pregnancy","Maternal mortality","Neonatal mortality","Maternal Cause of Death","Neonatal Cause of Death",{"date":111,"type":37},"2026-01-21",{"date":113,"type":37},"2008-05",{"date":115,"type":21},"2030-05",{"name":43,"class":44},15,""]