Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT05053269
Status:
WITHDRAWN
Last Update Posted:
2023-05-01
First Post:
2021-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Weight Growth After Birth and Bronchopulmonary Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'none was included', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2021-09-12', 'studyFirstSubmitQcDate': '2021-09-15', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of BPD', 'timeFrame': "up to 36 weeks' gestational age", 'description': 'the infant was diagnosed with BPD'}], 'secondaryOutcomes': [{'measure': 'body weight growth after birth', 'timeFrame': "up to 36 weeks' gestational age", 'description': 'to assess whether body weight growth after birth is consistent with the growth curve'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchopulmonary Dysplasia', 'Preterm']}, 'descriptionModule': {'briefSummary': 'Bronchopulmonary dysplasia (BPD) is one of the most common, complex, and severe diseases in preterm infants. BPD was first described as chronic pulmonary disease in survivors of severe respiratory distress syndrome (RDS) in 1967, which was also called as the "old" BPD. In recent years, the definition for BPD has developed a lot. The National Institute of Child Health and Human Development (NICHD) workshop in 2018 assessed BPD at 36 post-menstrual age (PMA) along with radiographic confirmation and used a severity grading of I-III. Although with effective surfactant supplement and oxygen support, BPD brings a great challenge to neonatologists.', 'detailedDescription': 'Besides persistent inflammation, prolonged invasive ventilation and oxidative damage. body weight is the one of the most important factors to induce BPD. Poor extrauterine growth is commonly described in extremely preterm infants. But, the relationship of postnatal growth with BPD and respiratory morbidity is not entirely understood.\n\nThe aim of the present study is to assess whether body weight growth after birth is the risk factor for BPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '1 Minute', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "the preterm infants' gestational age is equal to or less than 32 weeks will be included in the study", 'eligibilityCriteria': "Inclusion Criteria:\n\n* equal to or less than 32 weeks' gestational age\n\nExclusion Criteria:\n\n* main congenital malformation\n* parents' refusal"}, 'identificationModule': {'nctId': 'NCT05053269', 'briefTitle': 'Body Weight Growth After Birth and Bronchopulmonary Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Association of Body Weight Growth After Birth and Bronchopulmonary Dysplasia(BPD)', 'orgStudyIdInfo': {'id': '2020228'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'good body weight growth', 'description': 'body weight growth after birth is consistent with the growth curve', 'interventionNames': ['Other: good body weight growth']}, {'label': 'poor body weight growth', 'description': 'body weight growth after birth is inconsistent with the growth curve', 'interventionNames': ['Other: poor body weight growth']}], 'interventions': [{'name': 'good body weight growth', 'type': 'OTHER', 'description': 'body weight growth after birth is consistent with the growth curve', 'armGroupLabels': ['good body weight growth']}, {'name': 'poor body weight growth', 'type': 'OTHER', 'description': 'body weight growth after birth is inconsistent with the growth curve', 'armGroupLabels': ['poor body weight growth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': "Children's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'Chen Long,MD', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}