L-arginine Concentrations and CPS Polymorphisms in VLBW Infants

NCT00554866 | Completed

• 1 other identifier: 07-2-018
• Study Type: interventional
• Target: 477
• Locations: 3 countries
• Sites: 4

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.

Conditions

Infant, Very Low Birth Weight

Outcome Measures

Primary Outcomes (1)

• the association between the T1405N SNP in the CPS-1 gene and lower plasma L-arginine concentrations

  2 years

Secondary Outcomes (1)

• To determine whether the T1405N SNP in the CPS-1 gene is associated with a higher risk of NEC

  4 years

Study Arms (1)

VLBW between 6 and12 hours after birth

EXPERIMENTAL

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

Interventions

blood sample and buccal swab sample OTHER

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.

Also known as: OmniSwab

VLBW between 6 and12 hours after birth

Eligibility Criteria

• Age: 6 Hours - 12 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (4)

Carlo Poma Hospital

Mantova, Italy

Location

Cattedra di Neonatologia-Università degli Studi di Milano

Milan, Italy

Location

Maastricht University Hospital

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Complejo Universitario Hospitalario Insular-Materno Infantil

Las Palmas de Gran Canaria, 35016, Spain

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Eduardo Villamor, MD, PhD

  Maastricht University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 7, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2014
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

NL (1); ES (1); IT (2)