Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-02 @ 10:33 AM
Study NCT ID:
NCT04143204
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2019-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition and Growth in Very Preterm Infants
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': 'D004435', 'term': 'Eating'}, {'id': 'D007334', 'term': 'Insulin-Like Growth Factor I'}, {'id': 'D020738', 'term': 'Leptin'}, {'id': 'D054439', 'term': 'Ghrelin'}, {'id': 'D002096', 'term': 'C-Peptide'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D013002', 'term': 'Somatomedins'}, {'id': 'D000096764', 'term': 'Insulin-Like Peptides'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D054392', 'term': 'Adipokines'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2019-10-26', 'studyFirstSubmitQcDate': '2019-10-26', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Z-scores of weight', 'timeFrame': 'at corrected age 40 gestational weeks', 'description': 'Computed according to the Fenton preterm growth standards (2013)'}], 'secondaryOutcomes': [{'measure': 'Z-scores of length/height', 'timeFrame': 'at corrected age 40 gestational weeks', 'description': 'Computed according to the Fenton preterm growth standards (2013)'}, {'measure': 'Z-scores of head circumference', 'timeFrame': 'at corrected age 40 gestational weeks', 'description': 'Computed according to the Fenton preterm growth standards (2013)'}, {'measure': 'Z-scores of weight', 'timeFrame': 'at corrected age 6 months and 18 months', 'description': 'Computed according to the WHO standards (2006)'}, {'measure': 'Z-scores of length/height', 'timeFrame': 'at corrected age 6 months and 18 months', 'description': 'Computed according to the WHO standards (2006)'}, {'measure': 'Z-scores of head circumference', 'timeFrame': 'at corrected age 6 months and 18 months', 'description': 'Computed according to the WHO standards (2006)'}, {'measure': 'Percentage of infants who achieve catch-up growth', 'timeFrame': 'at corrected age 6 months and 18 months', 'description': 'Catch-up growth is defined as weight, length/height or head circumference equal to or above the 25th percentile for corrected age, according to the WHO standards (2006).'}, {'measure': 'Body fat free mass', 'timeFrame': 'at corrected age 40 gestational weeks and 6 months', 'description': 'assessed by air displacement plethysmography (ADP)'}, {'measure': 'Body fat mass', 'timeFrame': 'at corrected age 40 gestational weeks and 6 months', 'description': 'assessed by air displacement plethysmography (ADP)'}, {'measure': 'Body fat proportion', 'timeFrame': 'at corrected age 40 gestational weeks and 6 months', 'description': 'assessed by air displacement plethysmography (ADP)'}, {'measure': 'Cognitive development outcome', 'timeFrame': 'at corrected age 18 months', 'description': 'It is examined by six areas of development measured by Griffith Mental Development Scales (GMDS) including locomotor, personal-social, hearing and language, eye and hand co-ordination, performance and practical reasoning. Developmental impairment is defined as a developmental quotient lying one standard deviation below the mean (\\<85) and includes mild impairments (70-84) and moderate/severe impairment (\\<70).'}, {'measure': 'Intestinal flora change', 'timeFrame': 'from birth to corrected age 18 months', 'description': 'The change of composition of intestinal flora in preterm infants. The composition of intestinal flora was test by 16s rRNA sequencing.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature', 'Growth']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the relation of early nutritional intake, especially oral nutrition intake, with growth and body composition among very preterm or very low birth weight infants.', 'detailedDescription': 'As the survival of very preterm infants increases, it is important to evaluate their long-term outcomes. Nutritional intake during early life was important to the growth and development in infants, especially in preterm infants. Studies found that early nutrition exposure in preterm infants can effect scored of Griffith Mental Development Scales and body fat percentage at later life. Insulin-like growth factor-1, leptin, Ghrelin, C-Peptide are associated with fat mass in children. And accumulation of fat and insulin resistance (IR) in the early postnatal period are related to metabolism diseases in adulthood. However, previous studies on nutrition and growth or the body composition of preterm infants were mostly completed in developed countries, and no relevant data were available in China. Therefore, this study aims to establish a prospective cohort of very preterm infants to observe the effects of nutritional exposure in early life on growth and body composition in later life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Very preterm or very low birth weight infants in NICU', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* infants born with a gestational age \\>=28 weeks and \\<32 weeks and/or a birth weight \\>=1000g and \\<1500g;\n* infants admitted to neonatal intensive care unit (NICU) of Children's hospital of Fudan University within 24h after birth.\n\nExclusion Criteria:\n\n* major congenital anomalies or heredity metabolic diseases;\n* severe disease or abdominal surgery during hospitalization;\n* death during hospitalization or discharge without medical advice;\n* small for gestational age."}, 'identificationModule': {'nctId': 'NCT04143204', 'briefTitle': 'Nutrition and Growth in Very Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Early Nutritional Intake and Growth in Very Preterm or Very Low Birth Weight Infants: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'NGPI2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'very preterm infants cohort', 'description': 'A prospective cohort of very preterm or very low birth weight infants from birth to corrected age 18 months.', 'interventionNames': ['Other: Oral nutritional intake']}], 'interventions': [{'name': 'Oral nutritional intake', 'type': 'OTHER', 'otherNames': ['All nutritional intake', 'Insulin-like growth factor 1', 'Leptin', 'Ghrelin', 'C-peptide'], 'description': 'The exposure are oral nutritional intake and all nutritional intake during early life (28 days), and insulin-like growth factor 1, leptin, Ghrelin, and C-peptide in serum at corrected age 40 gestational weeks.', 'armGroupLabels': ['very preterm infants cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Weili Yan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}