Low Birth WeightglutathioneNCT00607061
Synthesis of Glutathione From Low Birth Weight Newborn Babies
A study testing Blood sample collection in people with Low Birth Weight, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of the study is to determine mechanisms leading to glutathione deficiency in low birth weight newborn babies. Compared to full term neonates, depletion in this population may be due to a decreased synthesis rate or to an enhanced utilization or a combination of both mechanisms.The protocol is constituted of… Read more about this study
- Who is it for?
- Ages Up to 9 months
- Conditions the study is for
- Low Birth Weight
- What is being tested?
- Blood sample collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Jul 2010
- Phase
- Interventional
- 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 Up to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full term newborn babies
- Gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile
- Eutocic delivery
- Low birth weight newborn babies (gestational age < 32 weeks of amenorrhea and/or weight of birth < 1500 g and/or weight of birth < third percentile for their gestational age)
- Full term newborn babies (gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile)
Who cannot join
- Mother diastolic blood pressure > 90 mmHg during pregnancy,
- pH < 7.2 at umbilical cord and/or difference in pH < 0,02 between arterial pH and venous pH
- Dystocic delivery
- Bacterial or viral maternofoetal infection
- Foetal malformation
- Foetal disease
- Taking N-acetyl-cystein or vitamines and antioxidant minerals by the mother for the last 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro
The aim of the study is to determine mechanisms leading to glutathione deficiency in low birth weight newborn babies. Compared to full term neonates, depletion in this population may be due to a decreased synthesis rate or to an enhanced utilization or a combination of both mechanisms.The protocol is constituted of two steps. The objective of the first step is to quantify the blood concentration of glutathione in the artery and the vein of umbilical cord in full term newborn babies. Objectives of the second step are to determine if the glutathione synthesis rate, measured in vitro, is lower in erythrocytes collected from umbilical cord blood of low weight newborn babies compared to full term newborn babies. In this case, the next objective will be to determine if the adjunction of an excess of cysteine in vitro can restore the glutathione synthesis rate in these cells.
- Conditions
- Low Birth Weight
- Being tested
- Blood sample collection
- Keywords
- Glutathione, Cysteine, Synthesis rate, Newborns, Low birth weight newborn babies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionProcedure or surgery
Blood of the umbilical cord will be collected after delivery. A mother blood sample will be also collected in the few hours preceding delivery to determine glutathione and cysteine concentrations.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Full term newborn babies with gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile. Receives: Procedure: Blood sample collection |
| 2 | Other | Low birth weight newborn babies (gestational age < 32 weeks of amenorrhea and/or weight of birth < 1500 g and/or weight of birth < third percentile for their gestational age. Receives: Procedure: Blood sample collection |
| 3 | Other | Full term newborn babies (gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile). Receives: Procedure: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The glutathione concentration in umbilical cord in full term newborn babies, the glutathione concentration in umbilical cord of low birth weight newborn babies and the effect of the adjunction of an excess of cysteine on the glutathione synthesis rate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Birth WeightStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Alice KUSTER, Doctor, Principal investigator, Nantes University HospitalNorbert WINER, Doctor, Study chair, Nantes University HospitalJean-Christophe ROZE, Professor, Study chair, Nantes University HospitalDominique DARMAUN, Professor, Study chair, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607061
- Sponsor's protocol ID
- 06/12-O
- Acronym
- glutathione
- Status last verified
- Sep 2013
- First submitted
- 22 Jan 2008
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
De Luca A, Kuster A, Tea I, Darmaun D, Roze JC, Robins R, Hankard R. Plasma amino acid pools in the umbilical cord artery show lower 15N natural isotope abundance relative to the maternal venous pools. Isotopes Environ Health Stud. 2021 Mar;57(1):3-10. doi: 10.1080/10256016.2020.1817914. Epub 2020 Sep 24.
PubMed 32972258
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro
- ClinicalTrials.gov ID
- NCT00607061
- Acronym / sponsor ID
- glutathione / 06/12-O
- Conditions
- Low Birth Weight
- Keywords
- Glutathione, Cysteine, Synthesis rate, Newborns, Low birth weight newborn babies
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Feb 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.
The aim of the study is to determine mechanisms leading to glutathione deficiency in low birth weight newborn babies. Compared to full term neonates, depletion in this population may be due to a decreased synthesis rate or to an enhanced utilization or a combination of both mechanisms.The protocol is constituted of two steps. The objective of the first step is to quantify the blood concentration of glutathione in the artery and the vein of umbilical cord in full term newborn babies. Objectives of the second step are to determine if the glutathione synthesis rate, measured in vitro, is lower in erythrocytes collected from umbilical cord blood of low weight newborn babies compared to full term newborn babies. In this case, the next objective will be to determine if the adjunction of an excess of cysteine in vitro can restore the glutathione synthesis rate in these cells.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Blood sample collectionFull term newborn babies with gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile. |
| 2 | Other | Procedure: Blood sample collectionLow birth weight newborn babies (gestational age < 32 weeks of amenorrhea and/or weight of birth < 1500 g and/or weight of birth < third percentile for their gestational age. |
| 3 | Other | Procedure: Blood sample collectionFull term newborn babies (gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile). |
Who may qualify
- Ages
- Up to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Full term newborn babies
- Gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile
- Eutocic delivery
- Low birth weight newborn babies (gestational age < 32 weeks of amenorrhea and/or weight of birth < 1500 g and/or weight of birth < third percentile for their gestational age)
- Full term newborn babies (gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile)
Key exclusion criteria (7 listed)
- Mother diastolic blood pressure > 90 mmHg during pregnancy,
- pH < 7.2 at umbilical cord and/or difference in pH < 0,02 between arterial pH and venous pH
- Dystocic delivery
- Bacterial or viral maternofoetal infection
- Foetal malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood of the umbilical cord will be collected after delivery. A mother blood sample will be also collected in the few hours preceding delivery to determine glutathione and cysteine concentrations. | Procedure or surgery | 1, 2, 3 |
Primary outcome
The glutathione concentration in umbilical cord in full term newborn babies, the glutathione concentration in umbilical cord of low birth weight newborn babies and the effect of the adjunction of an excess of cysteine on the glutathione synthesis rate.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
- Derived from this study: PubMed 32972258De Luca A, Kuster A, Tea I, Darmaun D, Roze JC, Robins R, Hankard R. Plasma amino acid pools in the umbilical cord artery show lower 15N natural isotope abundance relative to the maternal venous pools. Isotopes Environ Health Stud. 2021 Mar;57(1):3-10. doi: 10.1080/10256016.2020.1817914. Epub 2020 Sep 24.
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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.
Alice KUSTER, Doctor principal investigator
Nantes University Hospital
Norbert WINER, Doctor study chair
Nantes University Hospital
Jean-Christophe ROZE, Professor study chair
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection in people with Low Birth Weight, run by Nantes University Hospital at 1 site in France.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Sep 2013. 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 France. 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 was stopped early. Results are not available in the source record.
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?
The glutathione concentration in umbilical cord in full term newborn babies, the glutathione concentration in umbilical cord of low birth weight newborn babies and the effect of the adjunction of an excess of cysteine on the glutathione synthesis rate.. 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 NCT00607061, which also lists 1 linked publication.
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 30 Sep 2013.