Synthesis of Glutathione From Low Birth Weight Newborn Babies
Information source: Nantes University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Birth Weight
Intervention: Blood sample collection (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Nantes University Hospital Official(s) and/or principal investigator(s):
Alice KUSTER, Doctor, Principal Investigator, Affiliation: CHU Nantes
Norbert WINER, Doctor, Study Chair, Affiliation: CHU Nantes
Jean-Christophe ROZE, Professor, Study Chair, Affiliation: CHU Nantes
Dominique DARMAUN, Professor, Study Chair, Affiliation: CHU Nantes
Overall contact:
Alice KUSTER, Doctor, Email: alice.kuster@chu-nantes.fr
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.
Clinical Details
Official title: Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro
Study design: Health Services Research, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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.
Eligibility
Minimum age: N/A.
Maximum age: 9 Months.
Gender(s): Both.
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):
- Lowbirth 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 antioxydant minerals by the mother for the
last 24 hours
Locations and Contacts
Alice KUSTER, Doctor, Email: alice.kuster@chu-nantes.fr
CHU de Nantes, Nantes 44000, France; Recruiting
Additional Information
Starting date: September 2007
Ending date: September 2009
Last updated: September 17, 2009
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