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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
Sponsor:
Information provided by:
Nantes University Hospital

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Low Birth Weight Procedure: Blood sample collection Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   up to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
CHU de Nantes
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
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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
More Information
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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
Keywords provided by Nantes University Hospital:
Glutathione
Cysteine
Synthesis rate
Newborns
Low birth weight newborn babies
Additional relevant MeSH terms:
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Body Weight
Birth Weight
Signs and Symptoms