Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT00554866
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2007-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
L-arginine Concentrations and CPS Polymorphisms in VLBW Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 477}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-27', 'studyFirstSubmitDate': '2007-11-06', 'studyFirstSubmitQcDate': '2007-11-06', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the association between the T1405N SNP in the CPS-1 gene and lower plasma L-arginine concentrations', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'To determine whether the T1405N SNP in the CPS-1 gene is associated with a higher risk of NEC', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infant, Very Low Birth Weight']}, 'descriptionModule': {'briefSummary': 'Plasma L-arginine concentrations are decreased in premature infants with necrotizing enterocolitis (NEC). A carbamoyl-phosphate synthetase 1 (CPS1) polymorphism has been correlated with low plasma concentrations of L-arginine in neonates (\\> 35 weeks of gestation). Recently Moonen et al (Pediatr Res 2007; 62(2):188-90) described a correlation between this CPS1 T1405N single nucleotide polymorphism (SNP) and the presence of NEC in VLBW infants. However there is no data about the correlation between the plasma arginine concentrations and the T1405N SNP in the CPS-1 gene in VLBW infants. In the present project we postulate that T1405N SNP in the CPS-1 gene is associated with lower plasma arginine concentrations and is also a risk factor for the development of NEC.', 'detailedDescription': 'Plasma L-arginine concentrations are decreased in premature infants with necrotizing enterocolitis (NEC). A C-to-A nucleotide transversion (T1405N) in the gene that encodes carbamoyl-phosphate synthetase 1 (CPS1), the rate-limiting enzyme in the urea cycle, has been correlated with low plasma concentrations of L-arginine in neonates (\\> 35 weeks of gestation). Recently Moonen et al (Pediatr Res 2007; 62(2):188-90) described a correlation between this CPS1 T1405N single nucleotide polymorphism (SNP) and the presence of NEC in VLBW infants. However there is no data about the correlation between the plasma arginine concentrations and the T1405N SNP in the CPS-1 gene in VLBW infants. In the present project we postulate that T1405N SNP in the CPS-1 gene is associated with lower plasma arginine concentrations and is also a risk factor for the development of NEC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Hours', 'minimumAge': '6 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* VLBW infants (\\< 30 weeks and \\< 1500 gram birth weight).\n\nExclusion Criteria:\n\n* Blood transfusion, enteral or parenteral protein intake, or inhaled nitric oxide administration before time of the blood sample (obtained between 6 and 12 hours after birth).\n* Parents not able to give informed consent.'}, 'identificationModule': {'nctId': 'NCT00554866', 'briefTitle': 'L-arginine Concentrations and CPS Polymorphisms in VLBW Infants', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Carbamoyl-phosphate Synthase Gene Polymorphisms Influencing Plasma L-arginine Concentrations in Preterm Infants', 'orgStudyIdInfo': {'id': '07-2-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VLBW between 6 and12 hours after birth', 'description': 'Blood sample and buccal swab sample. One blood sample (500 mL) will be obtained from each VLBW infant between 6 and12 hours after birth from an umbilical-artery or peripheral artery catheter.\n\nAdditional DNA collection buccal cell samples were obtained with a sterile OmniSwab.', 'interventionNames': ['Other: blood sample and buccal swab sample']}], 'interventions': [{'name': 'blood sample and buccal swab sample', 'type': 'OTHER', 'otherNames': ['OmniSwab'], 'description': 'one blood sample (500 mL) will be obtained from each VLBW infant between 6 and12 hours after birth from an umbilical-artery or peripheral artery catheter.\n\nAdditional DNA collection buccal cell samples were obtained with a sterile OmniSwab.', 'armGroupLabels': ['VLBW between 6 and12 hours after birth']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mantova', 'country': 'Italy', 'facility': 'Carlo Poma Hospital', 'geoPoint': {'lat': 45.16031, 'lon': 10.79784}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Cattedra di Neonatologia-Università degli Studi di Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '6202 AZ', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '35016', 'city': 'Las Palmas de Gran Canaria', 'country': 'Spain', 'facility': 'Complejo Universitario Hospitalario Insular-Materno Infantil', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}], 'overallOfficials': [{'name': 'Eduardo Villamor, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}