Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT05430594
Status:
UNKNOWN
Last Update Posted:
2022-06-24
First Post:
2022-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This Study Investigate the Impact of Maternal COVID-19 Infection During Birth on the Childrens' Physical and Mental Development.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-20', 'studyFirstSubmitDate': '2022-06-20', 'studyFirstSubmitQcDate': '2022-06-20', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurodevelopmental outcome', 'timeFrame': '2 years old'}], 'secondaryOutcomes': [{'measure': 'Neurodevelopmental outcome', 'timeFrame': '1 year old'}, {'measure': 'Phsycosomatic outcome', 'timeFrame': '1 and 2 years old'}, {'measure': 'Regulation disorders', 'timeFrame': '1 and 2 years old'}, {'measure': 'Feeding', 'timeFrame': '1 and 2 years old'}, {'measure': 'Maternal mental status', 'timeFrame': '1 and 2 years old'}]}, 'conditionsModule': {'keywords': ['followup', 'longterm outcome', 'child development', 'maternal COVID-19'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': "This study investigates the impact of the maternal COVID infection during birth on the children's development: physical and mental outcomes. We would like to differentiate the effect from the viral infection and effect of the pandemic period, too."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Months', 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Firstly we examine the infants at 1 year old. We do control examination if it is necessary or give advice. We did a next examination at 2 years old in every cases.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postitive maternal COVID test during the birth\n* the newborn was cared at the Semmelweis University after birth'}, 'identificationModule': {'nctId': 'NCT05430594', 'acronym': 'Coronababies', 'briefTitle': "This Study Investigate the Impact of Maternal COVID-19 Infection During Birth on the Childrens' Physical and Mental Development.", 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'Long-term Followup of Children Was Born From COVID Positive Mother During Birth', 'orgStudyIdInfo': {'id': 'SE RKEB: 14/2022.'}}, 'contactsLocationsModule': {'locations': [{'zip': '1078', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Fanni Toth, Dr', 'role': 'CONTACT', 'email': 'toth.fanni2@gamil.com'}], 'facility': 'Semmelweis University, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'centralContacts': [{'name': 'Fanni Toth, Dr', 'role': 'CONTACT', 'email': 'toth.fanni2@gmail.com', 'phone': '+36306924507'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}