Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-13 @ 7:45 AM
Study NCT ID:
NCT03553706
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2018-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indicators of Growth, Nutritional Status and Comorbide Disorders of Newborns With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-30', 'studyFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Categorization of subjects according to norms of growth rates for typical children and children with Down syndrome', 'timeFrame': '7 days', 'description': 'Comparison of children with Down syndrome according to values of birth weight, birth length and head circumference classified by anthropometric charts for typical children and anthropometric charts for children with DS'}, {'measure': 'Testing the differences of auxological characteristic according to gestational age', 'timeFrame': '7 days', 'description': 'Comparison of auxological parameters and auxological indexes of premature and term babies with DS'}, {'measure': 'Auxological characteristics of SGA, AGA and LGA children with DS by norms for DS', 'timeFrame': '7 days', 'description': 'Comparison of auxological parameters and auxological indexes between hypotrophic (SGA), eutrophic (AGA) and hypertrophic (HGA) children with DS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['growth restriction, nutritive status, comorbide disorders, Down Syndrome'], 'conditions': ['Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction']}, 'descriptionModule': {'briefSummary': 'Objective To access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with Down syndrome (DS)\n\nStudy design In this cohort retrospective study, 141 newborns with proven trisomy 21 born at the Department of Gynecology and Obstetrics of the University of Split Hospital (1990 to 2015) were included. The data were obtained from the medical histories of mothers, infants and the delivery protocol.\n\nThe objective was to access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with Down syndrome (DS)\n\nConclusion Higher CI were found in hyportrophic (SGA) newborns with DS and indicated their intrauterine growth restriction with brain sparing and increased further risk of severe psychomotor retardation. The SGA newborns have lower parameters and indexes of nutritive status and significantly differed from eutrophic and hypertrophic newborns. These SGA newborns with DS have increased developmental risks and that requires further diagnostic attention.', 'detailedDescription': 'Use of anthropometric charts developed specifically for children with DS have a better expression of real growth restriction (small for gestation age/SGA, 9.9%) than the application of the percentile curve for typical children (SGA, 24.1%). These differences were also noted in the evaluation of other anthropometric measures. Cephalization index (CI) proved to be the only predictor from the considered auxological parameters and indexes with minimal predictive value in the prediction of heart defects type ASD II and VSD.\n\nThe presence of comorbid disorders in newborns with DS did not have a significant predictive role on growth indicators and nutritive status of the newborn, but we noted a strong association between preterm births and white matter injury (WMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The perinatal outcome of 141 children with confirmed diagnosis of DS was evaluated retrospectively. 137 (137/141, 97.2%) children had the cytogenetic finding of regular trisomy 21, 3 (3/141, 2.1%) had the kariotypic finding of mosaicism and 1 child (1/ 141. %) had translocation 21/22.\n\nThere were more boys (74/141, 52.5%) than girls (67/141, 47.5%) in the examined sample.\n\nThe median of gestational age of newborns with DS was 38 weeks (range 37-38 weeks): 10 children were born at 40 weeks of gestation (7.1%), 34 at 38 weeks (24.1%), 24 at 37 weeks (16.3%), 15 children (10.6%) at 36 weeks; and 19 children from 32 to 35 weeks of gestation.\n\nThe median of gravidity for boys was the 3rd pregnancy, and for girls the 2nd pregnancy. The age range of the mother for both sexes was 31 to 35 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe study included newborns with proven trisomy 21 born at the Department of Gynecology and Obstetrics of the University of Split Hospital Center from 1990 to 2015\n\nExclusion Criteria:\n\n* excluded newborns with proven trisomy 21 died at first week of life'}, 'identificationModule': {'nctId': 'NCT03553706', 'acronym': 'DownSy', 'briefTitle': 'Indicators of Growth, Nutritional Status and Comorbide Disorders of Newborns With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Split'}, 'officialTitle': 'Interference Indicators of Growth, Nutritional Status and Comorbid Malformations of Newborns With Down Syndrome (DS)', 'orgStudyIdInfo': {'id': 'KBC2052018'}}, 'contactsLocationsModule': {'locations': [{'zip': '+385 21', 'city': 'Split', 'state': 'Dalmatia', 'country': 'Croatia', 'facility': 'Asija Rota Ceprnja', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}], 'overallOfficials': [{'name': 'Asija Rota Ceprnja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Split Department for Rehabilitation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Split', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asija Rota Ceprnja, MD., specialist of rehabilitation', 'investigatorFullName': 'Asija Rota Ceprnja', 'investigatorAffiliation': 'University Hospital of Split'}}}}