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Completed

NCT Number: NCT00791687

Prenatal Corticosteroids and Antioxidants in Preterm Infants

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.

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Key information

Conditions

Oxidative Stress Dyspnea Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Neonatology; University Hospital La Fe

Valencia, 46009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of glutathione redox status in cord blood.

    Time frame: at birth

Secondary outcomes

  1. Evaluation of antioxidant activity.

    Time frame: at birth

Sponsors and collaborators

Lead sponsor

Fundacion Para La Investigacion Hospital La Fe

Other

Collaborators

  • Carlos III Health Institute
  • University of Valencia

Registry information

Official study title

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

Acronym: RESOX

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Nov 14, 2008
Registry last updated
Nov 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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