Prenatal Corticosteroids and Antioxidants in Preterm Infants - Full Text View

Sponsors and Collaborators:	Fundacion Para La Investigacion Hospital La Fe University of Valencia Carlos III Health Institute
Information provided by:	Fundacion Para La Investigacion Hospital La Fe
ClinicalTrials.gov Identifier:	NCT00791687

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:	Case Control, Prospective
Official Title:	Prenatal Corticosteroids Enhance the Antioxidant Defense System in Extremely Low Gestational Age Neonates

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants

Drug Information available for: Corticosteroids

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Biospecimen Retention: None Retained

Biospecimen Description:

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

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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. 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.

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. Review.

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. Review.

Responsible Party:	Valencian Agency for Health ( Maximo Vento )
Study ID Numbers:	PI08/0027
Study First Received:	November 13, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00791687 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica

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

Study placed in the following topic categories:

Antioxidants
Stress

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009