[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643415":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":44,"responsibleParty":49,"collaborators":51,"id":57,"slug":44,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":44,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":44,"overallStatus":80,"whyStopped":44,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":44},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-enhanced IMCI","EXPERIMENTAL","Participants randomized to this arm undergo Integrated Management of Childhood Illness (IMCI) assessment enhanced by the StethoMe AI-enabled digital stethoscope. After the routine health worker IMCI evaluation, a study clinician performs a structured IMCI-based respiratory assessment and obtains digital lung-sound recordings at four standardized chest positions with the StethoMe device. The embedded algorithm computes respiratory rate and classifies abnormal lung sounds (crackles, wheezes) in real time. AI outputs remain concealed from health workers, study staff, and caregivers and do not influence clinical management. The intervention is the StethoMe AI-enabled digital stethoscope, which is applied during a single clinic encounter.",[13],"Device: StethoMe AI-enabled digital stethoscope system",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard IMCI","ACTIVE_COMPARATOR","Participants randomized to this arm receive standard IMCI assessment per WHO guidelines, in which pneumonia is classified using respiratory rate and chest indrawing without AI-enabled digital auscultation. Routine clinic health workers perform the IMCI evaluation and make all management decisions, including antibiotic prescription or referral. The intervention is the standard IMCI assessment, which is delivered during a single clinic encounter.",[19],"Diagnostic Test: Standard IMCI assessment",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","StethoMe AI-enabled digital stethoscope system","A CE-marked (EU Class IIa) wireless electronic stethoscope paired with a mobile application and an on-device deep convolutional recurrent neural network trained on more than 25,000 labeled lung-sound recordings. The device captures high-fidelity respiratory sounds, automatically computes respiratory rate, and classifies sounds in real time as normal or abnormal (fine\u002Fcoarse crackles, high-\u002Flow-pitched wheezes), with ambient-noise detection to flag low-quality signals. Recordings are obtained at four standardized chest positions; the algorithm's classifications are generated automatically but the output display is permanently disabled for field users so results stay concealed and do not inform care.",[9],[27],"StethoMe, AI-enhanced IMCI",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DIAGNOSTIC_TEST","Standard IMCI assessment","The World Health Organization's standardized clinical algorithm for children with cough and\u002For difficult breathing, in which pneumonia is classified on the basis of age-specific fast breathing and\u002For chest indrawing in the absence of general danger signs, without digital or AI-assisted auscultation. Conducted by routine clinic health workers using standard equipment, it represents the current WHO-recommended standard of care for outpatient pneumonia assessment.",[15],[34],"WHO Integrated Management of Childhood Illness, IMCI",[36],{"name":37,"affiliation":5,"role":38},"Eric McCollum, MD, MPH","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Eric D McCollum, MD,MPH","CONTACT","410-955-2035",null,"emccoll3@jhmi.edu",{"name":47,"role":42,"phone":43,"phoneExt":44,"email":48},"Sunaina Kapoor, MD,MPH","skapoor@jhmi.edu",{"type":50,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[52,54],{"name":53,"class":6},"University of Stellenbosch",{"name":55,"class":56},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100643415",false,"NCT07631377","The LalelaLung Study: Digital Stethoscope Clinical Evaluation","LaLeLa","Inclusion Criteria:\n\n* Age 2 to 59 months at the time of screening\n* Presence of cough and\u002For difficulty breathing\n* No WHO-defined emergency\u002Fdanger signs (e.g., grunting, cyanosis, apnea, convulsions, or altered level of consciousness)\n* A legal caregiver is present, able to understand the study information, and willing to provide written informed consent\n* Caregiver is willing and able to provide contact information (e.g., mobile phone number) to allow 7-day follow-up after the clinic visit\n\nExclusion Criteria:\n\n* Presence of WHO-defined emergency signs requiring immediate referral or hospital admission (grunting, cyanosis, apnea, uncompensated shock, convulsions, diarrhea with severe dehydration, or altered level of consciousness)\n* Critical illness or clinical instability judged by the screening clinician or study physician to require urgent medical attention\n* Age outside the target range (younger than 2 months or older than 59 months)\n* Previous enrollment in the study\n* Refusal or withdrawal of informed consent by the legal caregiver at any time prior to randomization","ALL","2 Months","59 Months",{"count":67,"type":68},350,"ESTIMATED","INTERVENTIONAL",[71],"PHASE4","Pneumonia is the leading infectious cause of death in children under five years of age worldwide, and most of these deaths occur in low- and middle-income countries. In these settings, frontline health workers diagnose pneumonia using the World Health Organization's Integrated Management of Childhood Illness (IMCI) guidelines, which rely mainly on counting how fast a child is breathing and checking for chest indrawing. This approach has saved many lives, but it is not very specific. As a result, many children who actually have self-limiting viral illnesses that do not require antibiotics are nonetheless treated with antibiotics, contributing to the global rise of antimicrobial resistance.\n\nNew digital stethoscopes paired with artificial intelligence (AI) can record a child's lung sounds and automatically detect abnormal sounds such as crackles and wheezes with accuracy comparable to physicians. The LaLeLa Lung Study will evaluate whether adding an AI-enabled digital stethoscope to standard IMCI assessment improves the accuracy of pneumonia diagnosis among children aged 2 to 59 months who present with cough and\u002For difficult breathing at a primary care clinic in Cape Town, South Africa.\n\nThe main component (Objective 1) is a randomized, triple-blinded diagnostic accuracy study that will enroll 350 children, randomly assigned in a 1:1 ratio to either IMCI care enhanced by the AI-enabled digital stethoscope or standard IMCI care. An independent panel of physicians, blinded to the AI results and to study-arm assignment, will review each case and serve as the reference standard for determining whether pneumonia was truly present. The investigators hypothesize that IMCI enhanced by the AI stethoscope will diagnose pneumonia more accurately, and target antibiotics more appropriately, than standard IMCI alone. Nested sub-studies will additionally evaluate a second AI stethoscope for tuberculosis detection, a wearable lung-sound and respiratory-rate patch, an automated respiratory-rate monitor, and a smartphone-connected pulse oximeter.\n\nA separate component (Objective 2) is a mixed-methods implementation study at a second clinic that will assess how easily health workers can use these devices, how acceptable the devices are to health workers and caregivers, and how well the devices fit into routine clinic workflows.\n\nThroughout the study, all AI-generated results will remain concealed from clinic staff, study clinicians, and caregivers, so the AI-generated results will not influence the care any child receives. All children continue to receive standard IMCI care. Findings will help inform whether AI-enabled digital auscultation should be integrated into childhood pneumonia care in South Africa and similar low-resource settings, with the goal of improving diagnosis, strengthening antibiotic stewardship, and reducing antimicrobial resistance and child mortality.",[74,75,76,77,78,79],"Pneumonia","Tuberculosis, Pulmonary","Respiratory Tract Infections","Bronchiolitis","Respiratory Sounds","Antibiotic Resistant Strain","NOT_YET_RECRUITING","2026-06-05",{"date":83,"type":84},"2026-06-09","ACTUAL",{"date":86,"type":68},"2026-07-20",{"date":88,"type":68},"2028-06-30",{"name":5,"class":6}]