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

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

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
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 |
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 |