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L-arginine Concentrations and CPS Polymorphisms in VLBW Infants

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ClinicalTrials.gov Identifier: NCT00554866
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infant, Very Low Birth Weight Other: blood sample and buccal swab sample Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 477 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Carbamoyl-phosphate Synthase Gene Polymorphisms Influencing Plasma L-arginine Concentrations in Preterm Infants
Study Start Date : July 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2014

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: VLBW between 6 and12 hours after birth

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.

Additional DNA collection buccal cell samples were obtained with a sterile OmniSwab.

Other: 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.

Additional DNA collection buccal cell samples were obtained with a sterile OmniSwab.

Other Name: OmniSwab



Primary Outcome Measures :
  1. the association between the T1405N SNP in the CPS-1 gene and lower plasma L-arginine concentrations [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To determine whether the T1405N SNP in the CPS-1 gene is associated with a higher risk of NEC [ Time Frame: 4 years ]


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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • VLBW infants (< 30 weeks and < 1500 gram birth weight).

Exclusion Criteria:

  • 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).
  • Parents not able to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554866


Locations
Italy
Carlo Poma Hospital
Mantova, Italy
Cattedra di Neonatologia-Università degli Studi di Milano
Milano, Italy
Netherlands
Maastricht University Hospital
Maastricht, Limburg, Netherlands, 6202 AZ
Spain
Complejo Universitario Hospitalario Insular-Materno Infantil
Las Palmas de Gran Canaria, Spain, 35016
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Eduardo Villamor, MD, PhD Maastricht University Hospital

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00554866     History of Changes
Other Study ID Numbers: 07-2-018
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms