Prenatal Corticosteroids and Antioxidants in Preterm Infants (RESOX)

This study has been completed.
Sponsor:
Collaborators:
University of Valencia
Carlos III Health Institute
Information provided by:
Fundacion Para La Investigacion Hospital La Fe
ClinicalTrials.gov Identifier:
NCT00791687
First received: November 13, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 13, 2008
November 13, 2008
January 2003
January 2005   (final data collection date for primary outcome measure)
Evaluation of glutathione redox status in cord blood. [ Time Frame: at birth ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Evaluation of antioxidant activity. [ Time Frame: at birth ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prenatal Corticosteroids and Antioxidants in Preterm Infants
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Extremely low gestational age neonates < 28 weeks gestation whose mothers received or not antenatal glucocorticosteroids.

Oxidative Stress
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00791687
PI08/0027
No
Maximo Vento, Valencian Agency for Health
Fundacion Para La Investigacion Hospital La Fe
  • University of Valencia
  • Carlos III Health Institute
Principal Investigator: MAXIMO VENTO, PHD, MD Valencian Agency of Health
Fundacion Para La Investigacion Hospital La Fe
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP