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

Tracking Information

First Received Date ^ICMJE

November 13, 2008

Last Updated Date

November 13, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of glutathione redox status in cord blood. [ Time Frame: at birth ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Evaluation of antioxidant activity. [ Time Frame: at birth ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Prenatal Corticosteroids and Antioxidants in Preterm Infants

Official Title ^ICMJE

Prenatal Corticosteroids Enhance the Antioxidant Defense System in Extremely Low Gestational Age Neonates

Brief Summary

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Biospecimen

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Oxidative Stress

Intervention ^ICMJE

Study Group/Cohort (s)

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.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2005

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00791687

Other Study ID Numbers ^ICMJE

PI08/0027

Has Data Monitoring Committee

Responsible Party

Maximo Vento, Valencian Agency for Health

Study Sponsor ^ICMJE

Fundacion Para La Investigacion Hospital La Fe

Collaborators ^ICMJE

University of Valencia
Carlos III Health Institute

Investigators ^ICMJE

Principal Investigator:

MAXIMO VENTO, PHD, MD

Valencian Agency of Health

Information Provided By

Fundacion Para La Investigacion Hospital La Fe

Verification Date

November 2008

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

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