Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-25 @ 4:50 PM
Study NCT ID:
NCT06071403
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The serum will be used to test the concentration of insulin-like growth factor 1.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 416}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'short-term weight and long-term weight', 'timeFrame': "at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age", 'description': 'weight'}, {'measure': 'short-term head circumference and long-term head circumference', 'timeFrame': "at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age", 'description': 'head circumference'}, {'measure': 'short-term length and long-term length', 'timeFrame': "at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age", 'description': 'length'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth Retardation']}, 'descriptionModule': {'briefSummary': 'This study aims to estimate short-term and long-term effects of time points to cease parenteral nutrition on very preterm infants, such as growth; to estimate the role of insulin-like growth factor 1 in the growth.', 'detailedDescription': "At present, it is unclear when to cease parenteral nutrition, the effects of cessation times on preterm infants' growth, and whether insulin-like growth factor 1 (IGF-1) has a mediation effect in the procedure that nutrients regulate the growth in preterm infants.\n\nTherefore, a prospective cohort study was designed with the aims:\n\n1. to estimate the association between the time to cease parenteral nutrition and the growth in very low birth weight;\n2. to investigate the relationship between nutrient volume in parenteral nutrition and growth in very low birth weight;\n3. to analyze the IGF-1 mediation effect between nutrient volume and growth regulations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Very low birth weight infants(birth weight less than 1500 grams)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Infants with a birth weight less than 1500 grams\n2. Infants admitted within 72 hours after birth\n3. Infants born from July 1, 2023, to June 30, 2024\n4. Written informed consent from parents or guardians\n\nExclusion Criteria:\n\n1. Infants with congenital abnormality\n2. Infants surviving \\<7 days after birth'}, 'identificationModule': {'nctId': 'NCT06071403', 'briefTitle': 'The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants--A Multicenter Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'IRB00001052-23093'}}, 'armsInterventionsModule': {'armGroups': [{'label': '60-70% group', 'description': 'We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)\\*100%).', 'interventionNames': ['Other: (enteral feeding volume/ total fluid volume)*100%']}, {'label': '71-80% group', 'description': 'We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)\\*100%).', 'interventionNames': ['Other: (enteral feeding volume/ total fluid volume)*100%']}, {'label': '81-90% group', 'description': 'We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)\\*100%).', 'interventionNames': ['Other: (enteral feeding volume/ total fluid volume)*100%']}], 'interventions': [{'name': '(enteral feeding volume/ total fluid volume)*100%', 'type': 'OTHER', 'description': '(enteral feeding volume/ total fluid volume)\\*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume', 'armGroupLabels': ['60-70% group', '71-80% group', '81-90% group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xingtai', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Guo, Doctor', 'role': 'CONTACT', 'email': 'guowei_xt@126.com', 'phone': '13932903599'}, {'name': 'Yanguo Zhao, Master', 'role': 'CONTACT', 'phone': '19831695015'}], 'facility': 'Wei Guo', 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}], 'centralContacts': [{'name': 'Shuaijun Li, doctor', 'role': 'CONTACT', 'email': '18811331226@163.com', 'phone': '18811331226'}, {'name': 'Shuag Zhou, doctor', 'role': 'CONTACT', 'email': 'zhoushuang0601@bjmu.edu.cn', 'phone': '13296688543'}], 'overallOfficials': [{'name': 'Shuaijun Li, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctor, Attending physician', 'investigatorFullName': 'Li Shuaijun', 'investigatorAffiliation': 'Peking University'}}}}