L-arginine Concentrations and CPS Polymorphisms in VLBW Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00554866
First received: November 6, 2007
Last updated: October 27, 2015
Last verified: October 2015

November 6, 2007
October 27, 2015
July 2007
December 2009   (final data collection date for primary outcome measure)
the association between the T1405N SNP in the CPS-1 gene and lower plasma L-arginine concentrations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
the association between the T1405N SNP in the CPS-1 gene and lower plasma L-arginine concentrations [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00554866 on ClinicalTrials.gov Archive Site
To determine whether the T1405N SNP in the CPS-1 gene is associated with a higher risk of NEC [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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L-arginine Concentrations and CPS Polymorphisms in VLBW Infants
Carbamoyl-phosphate Synthase Gene Polymorphisms Influencing Plasma L-arginine Concentrations in Preterm Infants
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Infant, Very Low Birth Weight
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
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.

Intervention: Other: blood sample and buccal swab sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
477
December 2014
December 2009   (final data collection date for primary outcome measure)

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.
Both
up to 12 Hours   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Netherlands,   Spain
Belgium
 
NCT00554866
07-2-018
No
Not Provided
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Eduardo Villamor, MD, PhD Maastricht University Hospital
Maastricht University Medical Center
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP