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Prenatal Corticosteroids and Antioxidants in Preterm Infants (RESOX)

F

Fundacion Para La Investigacion Hospital La Fe

Status

Completed

Conditions

Oxidative Stress

Study type

Observational

Funder types

Other

Identifiers

NCT00791687
PI08/0027

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

57 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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