Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-05-17 @ 3:58 PM
Study NCT ID:
NCT03100305
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amino Acids Profiles in Premature Infants Receiving Nutritional Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014554', 'term': 'Urination'}], 'ancestors': [{'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-30', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amino acid profiles in blood', 'timeFrame': 'through the transition to enteral nutrition, an average of 1 month', 'description': 'Amino acid levels in blood'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Until the corrected gestational age is 37 weeks or discharged'}, {'measure': 'Height', 'timeFrame': 'Until the corrected gestational age is 37 weeks or discharged'}, {'measure': 'Head circumference', 'timeFrame': 'Until the corrected gestational age is 37 weeks or discharged'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Infant']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the changes of amino acid metabolic profiles in different nutritional stages of preterm infants and determine the effects of nutritional intervention on the amino acid metabolic status of preterm infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants who experience various nutritional stages including total parenteral nutrition, partial parenteral nutrition and enteral nutrition', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPremature infants, and admitted to hospital within 24 hours after birth; Documentation of informed consent; In need of receiving parenteral nutrition after birth;\n\nExclusion Criteria:\n\nPremature infants with a parenteral nutrition period of less than 3 days; Inborn error of metabolism; Chromosomal abnormalities or multiple malformations;'}, 'identificationModule': {'nctId': 'NCT03100305', 'briefTitle': 'Amino Acids Profiles in Premature Infants Receiving Nutritional Support', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'A Prospective Study of Amino Acids Profiles in Premature Infants Receiving Nutritional Support', 'orgStudyIdInfo': {'id': 'XH-17-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Extremely preterm infants', 'interventionNames': ['Other: Collection of blood and urine']}, {'label': 'Very preterm infants', 'interventionNames': ['Other: Collection of blood and urine']}, {'label': 'Moderately preterm infants', 'interventionNames': ['Other: Collection of blood and urine']}, {'label': 'Late preterm infants', 'interventionNames': ['Other: Collection of blood and urine']}], 'interventions': [{'name': 'Collection of blood and urine', 'type': 'OTHER', 'description': 'Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition', 'armGroupLabels': ['Extremely preterm infants', 'Late preterm infants', 'Moderately preterm infants', 'Very preterm infants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhenjuan He, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director of neonatal department', 'investigatorFullName': 'Zhenjuan He', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}