Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-18 @ 1:46 PM
Study NCT ID:
NCT01881256
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2013-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D044342', 'term': 'Malnutrition'}], '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'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2013-06-17', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Actual nutrient intake vs recommended nutrient requirements in preterm infants', 'timeFrame': '19 months', 'description': "Comparison of intake with requirements during the preterm infant's hospital stay and up to 2 months corrected gestational age."}], 'secondaryOutcomes': [{'measure': 'Longitudinal data on body composition in Irish preterm neonates', 'timeFrame': '19 months', 'description': 'Evaluation of appropriateness of current feeding regimens for achievement of optimal growth \\& body composition outcomes'}, {'measure': 'Longitudinal data on vitamin D intake and circulating 25(OH)D', 'timeFrame': '19 months', 'description': 'To examine the relationship between vitamin D intake and serum 25-hydroxyvitamin D concentrations and biomarkers of calcium handling by analysis of sequential serum samples.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preterm birth', 'Parenteral and enteral nutrition', 'Body composition in preterm infants'], 'conditions': ['Premature Birth of Newborn', 'Malnutrition; Intrauterine or Fetal, Small-for-dates']}, 'descriptionModule': {'briefSummary': 'This is a longitudinal, observational study on nutrition, growth and body composition in preterm infants. Aims to determine the adequacy of actual nutrient intake during the preterm period by investigating associations between macronutrient supply, growth, and body composition at 34-weeks gestation, term equivalent and 2-month corrected gestational age.', 'detailedDescription': 'Infants between 23 and 24 weeks gestation and with a birth weight of 500 to 1500 g are recruited to a longitudinal, observational study of nutrition, growth and body composition in Cork University Maternity Hospital, Ireland.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants admitted to Cork University Maternity Hospital Neonatal Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Babies with a birth weight ≤1.5kg and gestational age ≤34 weeks were considered eligible.\n\nExclusion Criteria:\n\n* presence of congenital abnormalities or conditions that interfere with growth or body composition (congenital diseases, chromosomal abnormalities, chronic lung disease, cardiac or gastrointestinal diseases).'}, 'identificationModule': {'nctId': 'NCT01881256', 'acronym': 'BabyGrow', 'briefTitle': 'The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University College Cork'}, 'officialTitle': 'The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants', 'orgStudyIdInfo': {'id': 'BabyGrow1 Study'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mairead E Kiely, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Cork'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Cork', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cork University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mairead Kiely', 'investigatorAffiliation': 'University College Cork'}}}}