L-arginine Concentrations and CPS Polymorphisms in VLBW Infants

Study Description

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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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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 ]

Eligibility Criteria

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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.

Contacts and Locations

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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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	October 28, 2015
Last Verified:	October 2015

Additional relevant MeSH terms:

Birth Weight; Body Weight; Signs and Symptoms