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CompletedNCT00791687RESOXUpdated Nov 14, 2008

Prenatal Corticosteroids and Antioxidants in Preterm Infants

An observational study in Oxidative Stress, sponsored by Fundacion Para La Investigacion Hospital La Fe. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2008-11-14.

Sponsored by Fundacion Para La Investigacion Hospital La Fe · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
57
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Oxidative Stress

Keywords

  • Antioxidant enzymes
  • Glutathione
  • Oxidative stress
  • Prematurity
  • Respiratory distress
  • Non enzymatic antioxidant defense system
  • Enzymatic antioxidant defense system
03

In context

Premature Birth

2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.

This study's enrollment of 57 is below the median of 115 across 798 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Fundacion Para La Investigacion Hospital La Fe is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gestational age \<28 weeks
  • Registered used or not of prenatal glucocorticosteroids by the mother

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
57 participants (actual)

Groups and 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.

06

What researchers measure

Primary outcomes

  1. Evaluation of glutathione redox status in cord blood.

    Time frame: at birth

Secondary outcomes

  1. Evaluation of antioxidant activity.

    Time frame: at birth

07

Study locations

1 site
  • Division of Neonatology; University Hospital La Fe
    Valencia, Valencia 46009, Spain
08

References and documents

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. doi: 10.1254/jphs.fp0060844. Epub 2008 Feb 9. PubMed 18270477 ↗
  • 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. PubMed 18043518 ↗
  • 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. PubMed 15710178 ↗
  • 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. PubMed 14713347 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2003, a primary completion of Jan 2005 and a completion of Jan 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2008
First posted
Nov 14, 2008
Start
Jan 2003
Primary completionActual
Jan 2005
CompletionActual
Jan 2005
Last update
Nov 14, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00791687
Lead sponsor
Fundacion Para La Investigacion Hospital La Fe
Collaborators
University of Valencia, Carlos III Health Institute
First posted
Nov 14, 2008
Start date
Jan 2003
Primary completion
Jan 2005
Completion
Jan 2005
Last update
Nov 14, 2008

Study contacts

MAXIMO VENTO, PHD, MD
principal investigator · Valencian Agency of Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Fundacion Para La Investigacion Hospital La Fe

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