Synthesis of Glutathione From Low Birth Weight Newborn Babies (glutathione)
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ClinicalTrials.gov Identifier: NCT00607061 |
Recruitment Status :
Terminated
First Posted : February 5, 2008
Last Update Posted : September 30, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Birth Weight | Procedure: Blood sample collection | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
1
Full term newborn babies with gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile.
|
Procedure: Blood sample collection
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. |
2
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.
|
Procedure: Blood sample collection
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. |
3
Full term newborn babies (gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile).
|
Procedure: Blood sample collection
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. |
- 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.

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Ages Eligible for Study: | up to 9 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (first step):
- Full term newborn babies
- Gestational age > 37 weeks of amenorrhea and weight of birth > tenth percentile
- Eutocic delivery
Inclusion Criteria (second step):
- 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)
Exclusion criteria (first and second step):
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607061
France | |
CHU de Nantes | |
Nantes, France, 44000 |
Principal Investigator: | Alice KUSTER, Doctor | CHU Nantes | |
Study Chair: | Norbert WINER, Doctor | CHU Nantes | |
Study Chair: | Jean-Christophe ROZE, Professor | CHU Nantes | |
Study Chair: | Dominique DARMAUN, Professor | CHU Nantes |
ClinicalTrials.gov Identifier: | NCT00607061 |
Other Study ID Numbers: |
06/12-O |
First Posted: | February 5, 2008 Key Record Dates |
Last Update Posted: | September 30, 2013 |
Last Verified: | September 2013 |
Glutathione Cysteine Synthesis rate Newborns Low birth weight newborn babies |
Body Weight Birth Weight |