Clinical trial NCT00791687: Prenatal Corticosteroids and Antioxidants in Preterm Infants
Official title: Prenatal Corticosteroids Enhance the Antioxidant Defense System in Extremely Low Gestational Age Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxidative Stress
Keywords: Antioxidant enzymes
Glutathione
Oxidative stress
Prematurity
Respiratory distress
Non enzymatic antioxidant defense system
Enzymatic antioxidant defense system
Lead sponsor: Fundacion Para La Investigacion Hospital La Fe
Sponsor class: OTHER
Collaborators: name: University of Valencia
name: Carlos III Health Institute
First posted: 2008-11-14
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Extremely low gestational age neonates \< 28 weeks gestation whose mothers received or not antenatal glucocorticosteroids.

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.

Eligibility 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

Primary outcomes:
measure: Evaluation of glutathione redox status in cord blood.
timeFrame: at birth
Secondary outcomes:
measure: Evaluation of antioxidant activity.
timeFrame: at birth
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Division of Neonatology; University Hospital La Fe
Study officials:
affiliation: Valencian Agency of Health
name: MAXIMO VENTO, PHD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1203/PDR.0b013e31815b43ee.
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. doi: 10.1016/j.taap.2004.07.008.
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. doi: 10.1089/152308604771978462.