Prenatal Corticosteroids and Antioxidants in Preterm Infants (RESOX)
November 13, 2008 updated by: Fundacion Para La Investigacion Hospital La Fe
Prenatal Corticosteroids Enhance the Antioxidant Defense System in Extremely Low Gestational Age Neonates
Premature infants are highly susceptible to oxidative stress because of the immaturity of their antioxidant defense system.
The use of prenatal glucocorticosteroids administered to the mother improves respiratory function and overall outcome.
The investigators hypothesize that prenatal glucocorticosteroids favor the expression and competence of the antioxidant defense system.
Study Overview
Status
Completed
Conditions
Detailed Description
This is an observational study recruiting extremely low gestational age neonates (<28 weeks gestation) whose mothers received or not full scheduled prenatal glucocorticosteroids. Healthy term newly born infants acted as controls.
At birth cord blood were drawn for the following analytical determinations: reduced and oxidized glutathione; malondialdehyde; superoxide dismutase; catalase; glutathione peroxidase; glutathione reductase; glutathione s-transferase. In addition, first urine voided was collected for ortho-tyrosine/phenylalanine and 8-hydroxy-2-oxo-deoxyguanosine/2-deoxyguanosine determination. Analytical data and clinical outcomes are compared.
Study Type
Observational
Enrollment (Actual)
57
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Valencia, Spain, 46009
- Division of Neonatology; University Hospital La Fe
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Extremely low gestational age neonates < 28 weeks gestation whose mothers received or not antenatal glucocorticosteroids.
Description
Inclusion Criteria:
- Gestational age <28 weeks
- Registered used or not of prenatal glucocorticosteroids by the mother
Exclusion Criteria:
- Use of pro-or-antioxidant drugs by the mother during gestation
- Major congenital malformations
- Prenatal inflammation (E.G.:chorioamnionitis)
- Chromosomopathies
- Uncertainty about gestational age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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PRENATAL CORTICOSTEROIDS
Extremely low gestational age neonates (<28 weeks gestation) whose mothers received full course of betamethasone before delivery.
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NON PRENATAL CORTICOSTEROIDS
Extremely low gestational age neonates (<28 weeks gestation) whose mothers did not receive full course of betamethasone before delivery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Evaluation of glutathione redox status in cord blood.
Time Frame: at birth
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at birth
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Evaluation of antioxidant activity.
Time Frame: at birth
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at birth
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: MAXIMO VENTO, PHD, MD, Valencian Agency of Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Arima M, Kumai T, Asoh K, Takeba Y, Murano K, Goto K, Tsuzuki Y, Mizuno M, Kojima T, Kobayashi S, Koitabashi Y. Effects of antenatal dexamethasone on antioxidant enzymes and nitric oxide synthase in the rat lung. J Pharmacol Sci. 2008 Feb;106(2):242-8. doi: 10.1254/jphs.fp0060844. Epub 2008 Feb 9.
- Chandrasekar I, Eis A, Konduri GG. Betamethasone attenuates oxidant stress in endothelial cells from fetal lambs with persistent pulmonary hypertension. Pediatr Res. 2008 Jan;63(1):67-72. doi: 10.1203/PDR.0b013e31815b43ee.
- Asikainen TM, White CW. Antioxidant defenses in the preterm lung: role for hypoxia-inducible factors in BPD? Toxicol Appl Pharmacol. 2005 Mar 1;203(2):177-88. doi: 10.1016/j.taap.2004.07.008.
- Asikainen TM, White CW. Pulmonary antioxidant defenses in the preterm newborn with respiratory distress and bronchopulmonary dysplasia in evolution: implications for antioxidant therapy. Antioxid Redox Signal. 2004 Feb;6(1):155-67. doi: 10.1089/152308604771978462.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
January 1, 2005
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
November 13, 2008
First Submitted That Met QC Criteria
November 13, 2008
First Posted (Estimate)
November 14, 2008
Study Record Updates
Last Update Posted (Estimate)
November 14, 2008
Last Update Submitted That Met QC Criteria
November 13, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PI08/0027
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