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Prenatal Corticosteroids and Antioxidants in Preterm Infants (RESOX)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00791687
First Posted: November 14, 2008
Last Update Posted: November 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Valencia
Carlos III Health Institute
Information provided by:
Fundacion Para La Investigacion Hospital La Fe
  Purpose
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.

Condition
Oxidative Stress

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prenatal Corticosteroids Enhance the Antioxidant Defense System in Extremely Low Gestational Age Neonates

Resource links provided by NLM:


Further study details as provided by Fundacion Para La Investigacion Hospital La Fe:

Primary Outcome Measures:
  • Evaluation of glutathione redox status in cord blood. [ Time Frame: at birth ]

Secondary Outcome Measures:
  • Evaluation of antioxidant activity. [ Time Frame: at birth ]

Enrollment: 57
Study Start Date: January 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
PRENATAL CORTICOSTEROIDS
Extremely low gestational age neonates (<28 weeks gestation) whose mothers received full course of betamethasone before delivery.
NON PRENATAL CORTICOSTEROIDS
Extremely low gestational age neonates (<28 weeks gestation) whose mothers did not receive full course of betamethasone before delivery.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Extremely low gestational age neonates < 28 weeks gestation whose mothers received or not antenatal glucocorticosteroids.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00791687


Locations
Spain
Division of Neonatology; University Hospital La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Fundacion Para La Investigacion Hospital La Fe
University of Valencia
Carlos III Health Institute
Investigators
Principal Investigator: MAXIMO VENTO, PHD, MD Valencian Agency of Health
  More Information

Publications:
Responsible Party: Maximo Vento, Valencian Agency for Health
ClinicalTrials.gov Identifier: NCT00791687     History of Changes
Other Study ID Numbers: PI08/0027
First Submitted: November 13, 2008
First Posted: November 14, 2008
Last Update Posted: November 14, 2008
Last Verified: November 2008

Keywords provided by Fundacion Para La Investigacion Hospital La Fe:
Antioxidant enzymes
Glutathione
Oxidative stress
Prematurity
Respiratory distress
Non enzymatic antioxidant defense system
Enzymatic antioxidant defense system

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs