Oxidative StressRESOXNCT00791687
Prenatal Corticosteroids and Antioxidants in Preterm Infants
An observational study of Oxidative Stress, run by Fundacion Para La Investigacion Hospital La Fe at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oxidative Stress
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2003to Jan 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Extremely low gestational age neonates < 28 weeks gestation whose mothers received or not antenatal glucocorticosteroids.
Who may be able to join
- Gestational age <28 weeks
- Registered used or not of prenatal glucocorticosteroids by the mother
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Division of Neonatology; University Hospital La Fe
Valencia, Valencia, 46009
About this study
Official title: Prenatal Corticosteroids Enhance the Antioxidant Defense System in Extremely Low Gestational Age Neonates
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.
- Conditions
- Oxidative Stress
- Keywords
- Antioxidant enzymes, Glutathione, Oxidative stress, Prematurity, Respiratory distress, Non enzymatic antioxidant defense system, Enzymatic antioxidant defense system
- Medical subject headings
- Premature Birth, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of glutathione redox status in cord blood.
Measured: at birth
Secondary outcomes (1)
Evaluation of antioxidant activity.
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startJan 2003
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Para La Investigacion Hospital La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia, Carlos III Health Institute
- Investigators
- MAXIMO VENTO, PHD, MD, Principal investigator, Valencian Agency of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791687
- Sponsor's protocol ID
- PI08/0027
- Acronym
- RESOX
- Status last verified
- Nov 2008
- First submitted
- 13 Nov 2008
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
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 18270477Chandrasekar 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 18043518Asikainen 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 15710178Asikainen 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Corticosteroids Enhance the Antioxidant Defense System in Extremely Low Gestational Age Neonates
- ClinicalTrials.gov ID
- NCT00791687
- Acronym / sponsor ID
- RESOX / PI08/0027
- Conditions
- Oxidative Stress
- Keywords
- Antioxidant enzymes, Glutathione, Oxidative stress, Prematurity, Respiratory distress, Non enzymatic antioxidant defense system, Enzymatic antioxidant defense system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Fundacion Para La Investigacion Hospital La FeUniversity, hospital or other
- Collaborators
- University of Valencia, Carlos III Health Institute
- Study start
- Jan 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Extremely low gestational age neonates < 28 weeks gestation whose mothers received or not antenatal glucocorticosteroids.
Key inclusion criteria (2 listed)
- Gestational age <28 weeks
- Registered used or not of prenatal glucocorticosteroids by the mother
Key exclusion criteria (5 listed)
- Use of pro-or-antioxidant drugs by the mother during gestation
- Major congenital malformations
- Prenatal inflammation (E.G.:chorioamnionitis)
- Chromosomopathies
- Uncertainty about gestational age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of glutathione redox status in cord blood.
Time frame: at birth
1 secondary outcome
Evaluation of antioxidant activity.
Time frame: at birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2008.
- Background: PubMed 18270477Arima 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.
- Background: PubMed 18043518Chandrasekar 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.
- Background: PubMed 15710178Asikainen 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.
- Background: PubMed 14713347Asikainen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAXIMO VENTO, PHD, MD principal investigator
Valencian Agency of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress, run by Fundacion Para La Investigacion Hospital La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of glutathione redox status in cord blood. (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00791687, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2008.