Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-01-05 @ 6:14 PM
Study NCT ID:
NCT03187067
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Pneumonia Lung Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Respiratory and blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-05', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-06-12', 'lastUpdatePostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LUS findings at enrollment', 'timeFrame': '8 hours'}], 'secondaryOutcomes': [{'measure': 'Repeat LUS findings', 'timeFrame': '30 days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['pneumonia', 'diagnostic', 'ultrasound', 'Pakistan', 'Mozambique'], 'conditions': ['Pneumonia', 'Acute Respiratory Infection']}, 'referencesModule': {'references': [{'pmid': '33707268', 'type': 'DERIVED', 'citation': 'Riaz A, Cambaco O, Ellington LE, Lenahan JL, Munguambe K, Mehmood U, Lamorte A, Qaisar S, Baloch B, Kanth N, Nisar MI, Volpicelli G, Bassat Q, Jehan F, Ginsburg AS. Feasibility, usability and acceptability of paediatric lung ultrasound among healthcare providers and caregivers for the diagnosis of childhood pneumonia in resource-constrained settings: a qualitative study. BMJ Open. 2021 Mar 11;11(3):e042547. doi: 10.1136/bmjopen-2020-042547.'}, {'pmid': '30622716', 'type': 'DERIVED', 'citation': 'Lenahan JL, Volpicelli G, Lamorte A, Jehan F, Bassat Q, Ginsburg AS. Multicentre pilot study evaluation of lung ultrasound for the management of paediatric pneumonia in low-resource settings: a study protocol. BMJ Open Respir Res. 2018 Dec 19;5(1):e000340. doi: 10.1136/bmjresp-2018-000340. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of LUS on the diagnosis and management of childhood pneumonia in developing countries'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases will be children 2 through 23 months of age who present to a study hospital with history of cough or difficulty breathing and chest indrawing. Controls will be children 2 through 23 months of age who present with cough or difficulty breathing, but without chest indrawing, fast breathing or fever.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (chest indrawing cases):\n\n* Male or female, 2 through 23 months of age\n* Cough \\<14 days or difficulty breathing\n* Visible indrawing of the chest wall, with or without fast breathing\n* Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to the study facility for a scheduled follow-up visit\n\nInclusion Criteria (non-chest indrawing controls):\n\n* Male or female, 2 through 23 months of age\n* Cough \\<14 days or difficulty breathing\n* Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to the study facility for a scheduled follow-up visit"}, 'identificationModule': {'nctId': 'NCT03187067', 'acronym': 'PLUS', 'briefTitle': 'Pediatric Pneumonia Lung Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Save the Children'}, 'officialTitle': 'Evaluation of Impact of Lung Ultrasound (LUS) on Management of Pneumonia in Low-resource Settings', 'orgStudyIdInfo': {'id': 'PLUS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mozambique, cases', 'interventionNames': ['Device: Lung ultrasound']}, {'label': 'Mozambique, controls', 'interventionNames': ['Device: Lung ultrasound']}, {'label': 'Pakistan, cases', 'interventionNames': ['Device: Lung ultrasound']}, {'label': 'Pakistan, controls', 'interventionNames': ['Device: Lung ultrasound']}], 'interventions': [{'name': 'Lung ultrasound', 'type': 'DEVICE', 'description': 'Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.', 'armGroupLabels': ['Mozambique, cases', 'Mozambique, controls', 'Pakistan, cases', 'Pakistan, controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manhiça', 'country': 'Mozambique', 'facility': 'Centro de Investigação em Saúde de Manhiça (CISM)', 'geoPoint': {'lat': -25.40222, 'lon': 32.80722}}, {'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Aga Khan University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Save the Children', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'Barcelona Institute for Global Health', 'class': 'OTHER'}, {'name': 'Aga Khan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}