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Prenatal Corticosteroids and Antioxidants in Preterm Infants

NCT ID: NCT00791687

Last Updated: 2008-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-01-31

Brief Summary

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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

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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.

Conditions

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Oxidative Stress

Keywords

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Antioxidant enzymes Glutathione Oxidative stress Prematurity Respiratory distress Non enzymatic antioxidant defense system Enzymatic antioxidant defense system

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PRENATAL CORTICOSTEROIDS

Extremely low gestational age neonates (\<28 weeks gestation) whose mothers received full course of betamethasone before delivery.

No interventions assigned to this group

NON PRENATAL CORTICOSTEROIDS

Extremely low gestational age neonates (\<28 weeks gestation) whose mothers did not receive full course of betamethasone before delivery.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role collaborator

Carlos III Health Institute

OTHER_GOV

Sponsor Role collaborator

Fundacion Para La Investigacion Hospital La Fe

OTHER

Sponsor Role lead

Responsible Party

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Valencian Agency for Health

Principal Investigators

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MAXIMO VENTO, PHD, MD

Role: PRINCIPAL_INVESTIGATOR

Valencian Agency of Health

Locations

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Division of Neonatology; University Hospital La Fe

Valencia, Valencia, Spain

Site Status

Countries

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Spain

References

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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. doi: 10.1254/jphs.fp0060844. Epub 2008 Feb 9.

Reference Type BACKGROUND
PMID: 18270477 (View on PubMed)

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. doi: 10.1203/PDR.0b013e31815b43ee.

Reference Type BACKGROUND
PMID: 18043518 (View on PubMed)

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. doi: 10.1016/j.taap.2004.07.008.

Reference Type BACKGROUND
PMID: 15710178 (View on PubMed)

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. doi: 10.1089/152308604771978462.

Reference Type BACKGROUND
PMID: 14713347 (View on PubMed)

Other Identifiers

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PI08/0027

Identifier Type: -

Identifier Source: org_study_id