NCT00791687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
Last Updated

November 14, 2008

Status Verified

November 1, 2008

Enrollment Period

2 years

First QC Date

November 13, 2008

Last Update Submit

November 13, 2008

Conditions

Oxidative Stress

Keywords

Antioxidant enzymesGlutathioneOxidative stressPrematurityRespiratory distressNon enzymatic antioxidant defense systemEnzymatic antioxidant defense system

Outcome Measures

Primary Outcomes (1)

  • Evaluation of glutathione redox status in cord blood.

    at birth

Secondary Outcomes (1)

  • Evaluation of antioxidant activity.

    at birth

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Extremely low gestational age neonates \< 28 weeks gestation whose mothers received or not antenatal glucocorticosteroids.

You may qualify if:

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

You may not qualify if:

  • Use of pro-or-antioxidant drugs by the mother during gestation
  • Major congenital malformations
  • Prenatal inflammation (E.G.:chorioamnionitis)
  • Chromosomopathies
  • Uncertainty about gestational age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Neonatology; University Hospital La Fe

Valencia, Valencia, 46009, Spain

Location

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

    PMID: 18270477BACKGROUND

  • 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.

    PMID: 18043518BACKGROUND

  • 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.

    PMID: 15710178BACKGROUND

  • 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.

    PMID: 14713347BACKGROUND

MeSH Terms

Conditions

Premature BirthDyspnea

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • MAXIMO VENTO, PHD, MD

    Valencian Agency of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

January 1, 2003

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

November 14, 2008

Record last verified: 2008-11

Locations

ES(1)