Prenatal Corticosteroids and Antioxidants in Preterm Infants

Oxidative Stress Clinical Trial

— RESOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791687
• Other study ID #: PI08/0027
• Status: Completed
• Phase: N/A
• First received: November 13, 2008
• Last updated: November 13, 2008
• Start date: January 2003
• Est. completion date: January 2005

Study information

• Verified date: November 2008
• Source: Fundacion Para La Investigacion Hospital La Fe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Oxidative Stress

Locations

Country	Name	City	State
Spain	Division of Neonatology; University Hospital La Fe	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion Para La Investigacion Hospital La Fe	Carlos III Health Institute, University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of glutathione redox status in cord blood.		at birth	No
Secondary	Evaluation of antioxidant activity.		at birth	No